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Aldin, Z., Diss, J., Mahmood, H., Sadik, T., Basra, H., Ahmed, M., . . . Sayed-Noor, A. (2024). Long-term effectiveness of transforaminal anterolateral approach CT-guided cervical epidural steroid injections for cervical radiculopathy treatment. Clinical Radiology
Open this publication in new window or tab >>Long-term effectiveness of transforaminal anterolateral approach CT-guided cervical epidural steroid injections for cervical radiculopathy treatment
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2024 (English)In: Clinical Radiology, ISSN 0009-9260, E-ISSN 1365-229XArticle in journal (Refereed) Epub ahead of print
Abstract [en]

Aim: To evaluate the long-term clinical effectiveness of computed tomography (CT)-guided transforaminal cervical epidural steroid injection using an anterolateral approach for the treatment of cervical radiculopathy (CR) using well-established robust clinical scoring systems for neck pain and neck disability. Despite its widespread use, evidence to support the long-term benefit of routine cervical epidural steroid injection is currently very limited.

Materials and methods: This study included 113 patients with magnetic resonance imaging (MRI)-confirmed CR who underwent a steroid injection at a single cervical level via a unilateral transforaminal anterolateral approach. Pain was assessed quantitatively at pre-injection, 15 minutes post-injection, 1 month, 3 months, and at 1 year. Neck disability was assessed using the Oswestry Neck Disability Index (NDI) at pre-injection, 1 month, 3 months, and 1 year time points.

Results: Eighty patients completed the study. Sixty per cent reported reduced neck pain (mean pain reduction, 55%), which was clinically significant in 45% cases. Furthermore, 66% reported an improvement in neck disability (mean improvement, 51%), which was clinically significant for 56% patients. Clinically significant good outcomes in both neck pain and neck disability were evident from as early as 1-month, and importantly, were independent both of pre-treatment CR characteristics (including severity of pre-injection neck pain or disability) and of findings on pre-injection MRI imaging.

Conclusion: Transforaminal anterolateral approach CT-guided epidural steroid injection resulted in a clinically significant long-term improvement in both neck pain and disability for half of the present cohort of patients with unilateral single-level CR. This improvement was independent of the severity of the initial symptoms and pre-injection MRI findings.

Place, publisher, year, edition, pages
Elsevier, 2024
National Category
Orthopaedics Physiotherapy
Identifiers
urn:nbn:se:umu:diva-221658 (URN)10.1016/j.crad.2024.01.022 (DOI)38369438 (PubMedID)2-s2.0-85185600975 (Scopus ID)
Available from: 2024-03-04 Created: 2024-03-04 Last updated: 2024-03-04
Schmidt, V., Gordon, M., Petterson, A., Buttazzoni, C., Seimersson, A., Sayed-Noor, A., . . . Wadsten, M. (2023). Functional outcomes are restored a decade after a distal radius fracture: a prospective long-term follow-up study. Journal of Hand Surgery, European Volume, Article ID 17531934231194682.
Open this publication in new window or tab >>Functional outcomes are restored a decade after a distal radius fracture: a prospective long-term follow-up study
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2023 (English)In: Journal of Hand Surgery, European Volume, ISSN 1753-1934, E-ISSN 2043-6289, article id 17531934231194682Article in journal (Refereed) Epub ahead of print
Abstract [en]

We performed an 11-13-year prospective follow-up of patients after a distal radial fracture (DRF) to investigate the association between fracture malunion, radiocarpal osteoarthritis and clinical outcome. In total, 292 patients responded to patient-reported outcome measures; of them, 242 underwent clinical examination. Clinical outcomes improved with time. A decade after fracture, median Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score was 5, EuroQol Five-dimensions score was 1.0, and range of motion and grip strength were 96% of the contralateral side. Neither osteoarthritis (6%) nor pseudoarthrosis of the ulnar styloid (30%) affected the outcomes. Dorsal tilt, radial inclination, ulnar variance and intra-articular extension did not affect long-term clinical outcomes or the risk of osteoarthritis. Recovery after a DRF is an ongoing process that lasts years. A decade after the injury event, range of motion, grip strength and QuickDASH were recovered to population normal, regardless of radiological outcomes.

Level of evidence: II.

Place, publisher, year, edition, pages
Sage Publications, 2023
Keywords
Distal radius fracture, functional outcomes, grip strength, long-term results, outcomes, patient-reported outcome measure, range of motion
National Category
Orthopaedics
Identifiers
urn:nbn:se:umu:diva-214296 (URN)10.1177/17531934231194682 (DOI)001061922700001 ()37684021 (PubMedID)2-s2.0-85170554329 (Scopus ID)
Available from: 2023-09-11 Created: 2023-09-11 Last updated: 2023-09-20
Schmidt, V., Mellstrand Navarro, C., Ottosson, M., Tägil, M., Christersson, A., Engquist, M., . . . Wadsten, M. (2022). Forecasting effects of "fast-tracks" for surgery in the Swedish national guidelines for distal radius fractures. PLOS ONE, 17(2), Article ID e0260296.
Open this publication in new window or tab >>Forecasting effects of "fast-tracks" for surgery in the Swedish national guidelines for distal radius fractures
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2022 (English)In: PLOS ONE, E-ISSN 1932-6203, Vol. 17, no 2, article id e0260296Article in journal (Refereed) Published
Abstract [en]

BACKGROUND AND PURPOSE: National guidelines for treatment of distal radius fractures (DRFs) were presented in Sweden in 2021. In the guidelines, a fast-track is recommended for 4 subgroups of highly unstable DRFs. Regardless of the results of the closed reduction these are recommended for surgery within 1 week of injury. This study aims to evaluate the potential consequences of the newly presented national guidelines on incidence of surgical interventions.

PATIENTS AND METHODS: In all, 1,609 patients (1,635 DRFs) with primary radiographs after a DRF between 2014 and 2017 at two Swedish hospitals were included in a retrospective cohort study. An estimation was made of the percentage of patients in the historical pre-guidelines cohort, that would have been recommended early primary surgery according to the new national guidelines compared to treatment implemented without the support of these guidelines.

RESULTS: On a strict radiological basis, 32% (516 out of 1635) of DRFs were classified into one of the 4 defined subgroups. At 9-13 days follow-up, cast treatment was converted into delayed primary surgery in 201 cases. Out of these, 56% (112 out of 201) fulfilled the fast-track criteria and would with the new guidelines have been subject to early primary surgery.

INTERPRETATION: The fast-track regimen in the new guidelines, has a high likelihood of identifying the unstable fractures benefitting from early primary surgery. If the proposed Swedish national guidelines for DRF treatment are implemented, a greater proportion of fractures would be treated with early primary surgery, and a delayed surgery avoided in the majority of cases. The potential benefits in relation to possible costs when using the fast-track criteria in every day practice are still unknown.

Place, publisher, year, edition, pages
Public Library of Science, 2022
National Category
Orthopaedics
Identifiers
urn:nbn:se:umu:diva-192459 (URN)10.1371/journal.pone.0260296 (DOI)000797657800004 ()35143508 (PubMedID)2-s2.0-85124387217 (Scopus ID)
Funder
Region Västernorrland, LVNFOU921951
Available from: 2022-02-14 Created: 2022-02-14 Last updated: 2023-09-05Bibliographically approved
Al-Amiry, B., Rahim, A., Knutsson, B., Mattisson, L. & Sayed-Noor, A. (2022). Kinesiophobia and its association with functional outcome and quality of life 6-8 years after total hip arthroplasty. Acta Orthopaedica et Traumatologica Turcica, 56(4), 252-255
Open this publication in new window or tab >>Kinesiophobia and its association with functional outcome and quality of life 6-8 years after total hip arthroplasty
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2022 (English)In: Acta Orthopaedica et Traumatologica Turcica, ISSN 1017-995X, Vol. 56, no 4, p. 252-255Article in journal (Refereed) Published
Abstract [en]

Objective: The aim of this study was to assess the incidence and severity of kinesiophobia, and to determine the relationship between Tampa Scale of Kinesiophobia (TSK) scores, functional outcome and quality of life (QoL) 6-8 years after Total Hip Arthroplasty (THA).

Methods: 161 patients (78 male and 83 female) with unilateral primary osteoarthritis (OA) treated with THA between September 2010 and December 2013 were included in this study. Western Ontario and McMaster Universities Osteoarthritis (WOMAC) and EQ-5D scores were measured preoperatively. At 6-8 years follow-up, these scores were repeated and TSK scores were also measured. According to the TSK, patients were divided into two groups for further comparisons and analysis: without kinesiophobia (TSK-score ≤ 36) and with kinesiophobia (TSK-score >36).

Results: There were 99 patients (61.5%) with no kinesiophobia (TSK score ≤ 36, TSK mean 28.4, SD 4.7) and 62 patients (38.5%) with kinesiophobia (TSK score > 36, TSK mean 42.8, SD 5.3). Patients with and without kinesiophobia were not statistically different regarding age, sex or body mass index. (P = 0.20, P = 0.99, P = 0.22, respectively). In the group with no kinesiophobia, the mean 6-8 years WOMAC was 12.4 (SD 15.6), while the absolute delta (Δ) value between preoperative and 6-8 years WOMAC was 46.2 (SD 20.4), compared to the group with kinesiophobia where the mean 6-8 years WOMAC was 32.2 (SD 23.4), while the absolute delta (Δ) value between preoperative and 6-8 years WOMAC was 32.3 (SD 25.5): both P < 0.001. The group with no kinesiophobia had a mean 6-8 years EQ-5D of 0.81 (SD 0.22), while the absolute delta (Δ) value between preoperative and 6-8 years EQ-5D was 0.44 (SD 0.26), compared to the group with kinesiopho-bia where the mean 6-8 years EQ-5D was 0.57 (SD 0.23), while the absolute delta (Δ) value between preoperative and 6-8 years EQ-5D was 0.33 (SD 0.26): P < 0.001 and P = 0.03, respectively. TSK scores were associated with worse WOMAC and EQ-5D scores, higher proportion of dependence on walking aids and increased THArelated adverse events (all P < 0.05).

Conclusion: This study has shown us that there is a high incidence of kinesiophobia 6-8 years after surgery and treating kinesiophobia early after THA might improve the outcome.

Level of Evidence: Level IV, Therapeutic Study.

Place, publisher, year, edition, pages
AVES, 2022
Keywords
Complications, Functional outcome, Hip arthroplasty, Kinesiophobia, Quality of life
National Category
Orthopaedics
Identifiers
urn:nbn:se:umu:diva-199204 (URN)10.5152/j.aott.2022.21318 (DOI)000860761700004 ()35968616 (PubMedID)2-s2.0-85136801843 (Scopus ID)
Available from: 2022-09-09 Created: 2022-09-09 Last updated: 2023-09-05Bibliographically approved
Torstensson, T., Sayed-Noor, A. & Knutsson, B. (2022). Physical inactivity before surgery for lumbar spinal stenosis is associated with inferior outcomes at 1-year follow-up: a cohort study. International Journal of Spine Surgery, 16(5), 916-920
Open this publication in new window or tab >>Physical inactivity before surgery for lumbar spinal stenosis is associated with inferior outcomes at 1-year follow-up: a cohort study
2022 (English)In: International Journal of Spine Surgery, E-ISSN 2211-4599, Vol. 16, no 5, p. 916-920Article in journal (Refereed) Published
Abstract [en]

Background: Lumbar spinal stenosis (LSS) is a common disorder in older people. Inactivity secondary to the disease state can further increase LSS symptoms. Initial care includes physiotherapy to relieve symptoms and optimize patient function and quality of life. It is currently unclear whether inactivity before surgery for LSS is associated with postoperative outcomes. Our aim was to investigate associations between self-reported exercise before LSS surgery and self-reported outcomes at 1-year follow-up.

Methods: Using a retrospective cohort study design, prospective data were collected from the National Swedish Register for Spine Surgery (Swespine) between September 2006 and December 2012: 11,956 patients diagnosed with LSS completed the 1-year follow-up. The primary outcome measure was the Oswestry Disability Index (ODI). Secondary outcome measures were back and leg pain reported on a visual analog scale (VAS). The independent variable was dichotomized into no regular exercise (NRE) and regular exercise (RE). Adjusted analysis of covariance models were used to analyze differences in outcome improvement between the NRE and RE groups.

Results: The mean improvement in the ODI was 15.9 (95% CI, 15.5–16.3) in the NRE group and 19.2 (95% CI, 18.5–19.8) in the RE group (P < 0.001). Improvement in back pain (P < 0.001) and leg pain (P < 0.001) were also inferior in the NRE group compared to the RE group. The NRE group improved 21.8 (95% CI, 21.2–22.5) units in back pain and 28.8 (95% CI, 28.1–29.5) in leg pain on the VAS compared to 25.2 (95% CI, 24.2–26.3) units in back pain and 32.5 (95% CI, 31.3–33.6) in leg pain in the RE group.

Conclusions: Inactivity defined as self-reported NRE before surgery for LSS is associated with worse outcomes 1-year postsurgery compared to patients reporting RE. Clinical Relevance: This study is relevant to currently practicing spinal surgeons and spine physiotherapists.

Place, publisher, year, edition, pages
International Society for the Advancement of Spine Surgery (ISASS), 2022
Keywords
inactivity, leg pain, low back pain, lumbar spinal stenosis, physical activity, physical function, spinal surgery
National Category
Orthopaedics
Identifiers
urn:nbn:se:umu:diva-201337 (URN)10.14444/8347 (DOI)000884696000022 ()36302609 (PubMedID)2-s2.0-85142320644 (Scopus ID)
Available from: 2022-12-14 Created: 2022-12-14 Last updated: 2022-12-14Bibliographically approved
Mukka, S., Sjöholm, P., Aziz, A., Eisler, T., Kadum, B., Krupic, F., . . . Sayed-Noor, A. (2020). A cohort study comparing internal fixation for undisplaced versus hip arthroplasty for displaced femoral neck fracture in the elderly: a pilot study for a clinical trial. Pilot and Feasibility Studies, 6, Article ID 98.
Open this publication in new window or tab >>A cohort study comparing internal fixation for undisplaced versus hip arthroplasty for displaced femoral neck fracture in the elderly: a pilot study for a clinical trial
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2020 (English)In: Pilot and Feasibility Studies, E-ISSN 2055-5784, Vol. 6, article id 98Article in journal (Refereed) Published
Abstract [en]

Introduction: The literature regarding undisplaced femoral neck fractures (FNF) is sparse. The aim of this prospective feasibility study is to compare the clinical outcome after undisplaced FNF treated with internal fixation (IF) and displaced FNF treated with hip arthroplasty. We hypothesized that hip arthroplasty would give a lower incidence of reoperations.

Methods: A total of 235 patients were included with a median age of 84 years (range 65-99). A consecutive series of 65 patients with undisplaced FNF were treated with IF, and 170 patients with displaced FNF were treated with either a total hip arthroplasty or a hemiarthroplasty. Follow-up interviews were conducted at 1 year using the Harris Hip Score (HHS), WOMAC, and pain numeric rating scale (PNRS). The minimum follow-up time was 22 months. There was no difference in baseline data between the groups.

Results: Nineteen (8%) hips required reoperation at least once at a mean of 6 months (range 0-35). The rate of reoperation was higher in the IF group compared to the hip arthroplasty group (13.8% vs. 5.9%, 95% CI 0.9-6.4). The overall 1-year and 2-year mortality was 28% and 40%, respectively, with no difference between the groups. The most common reasons for reoperations in the IF group were non-union and avascular necrosis, and 6 patients were treated with hip or excision arthroplasty. In the arthroplasty group, the most common indications were deep infection and dislocation. We did not find any differences between the groups in terms of HHS, WOMAC, and PNRS.

Conclusions: In this feasibility study, we found no differences in patient-reported outcomes between the groups although IF required a higher rate of reoperations. Further randomized trials are needed to establish the optimal treatment of undisplaced FNF in the elderly.

Trial registration: ClinicalTrial.org, NCT03392285. Retrospectively registered on 5 February 2018.

Place, publisher, year, edition, pages
Springer Nature, 2020
Keywords
Arthroplasty, Displaced, Hip fractures, Internal fixation, Reoperation, Undisplaced
National Category
Orthopaedics
Identifiers
urn:nbn:se:umu:diva-173567 (URN)10.1186/s40814-020-00642-w (DOI)000729238200103 ()32670600 (PubMedID)2-s2.0-85088144257 (Scopus ID)
Available from: 2020-07-20 Created: 2020-07-20 Last updated: 2023-09-05Bibliographically approved
Mukka, S., Rolfson, O., Mohaddes, M. & Sayed-Noor, A. (2020). The Effect of Body Mass Index Class on Patient-Reported Health-Related Quality of Life Before and After Total Hip Arthroplasty for Osteoarthritis: Registry-Based Cohort Study of 64,055 Patients. JBJS Open Access, 5(4), Article ID e20.00100.
Open this publication in new window or tab >>The Effect of Body Mass Index Class on Patient-Reported Health-Related Quality of Life Before and After Total Hip Arthroplasty for Osteoarthritis: Registry-Based Cohort Study of 64,055 Patients
2020 (English)In: JBJS Open Access, Vol. 5, no 4, article id e20.00100Article in journal (Refereed) Published
Abstract [en]

Background: Overweight status and obesity represent a global epidemic, with serious consequences at the individual and community levels. The number of total hip arthroplasties (THAs) among overweight and obese patients is expected to rise. Increasing body mass index (BMI) has been associated with a higher risk of mortality and reoperation and lower implant survival. The evaluation of perioperative health-related quality of life (HRQoL) has recently gained importance because of its direct relation to, and impact on, patients' physical, mental, and social well-being as well as health-service utilization. We sought to evaluate the influence of BMI class on HRQoL preoperatively and at 1 year following THA in a register-based cohort study.

Methods: This observational cohort study was designed and conducted on the basis of registry data derived from the Swedish Hip Arthroplasty Register (SHAR) and included 64,055 primary THAs registered between January 1, 2008, and December 31, 2015. Patients' baseline preoperative and 1-year postoperative EuroQol-5 Dimension-3 Level (EQ-5D-3L) responses were documented by the treating department and reported to the SHAR through the patient-reported outcome measures program. The EQ-5D-3L includes a visual analogue scale (EQ VAS), which measures the patient's overall health status.

Results: At 1 year of follow-up, all BMI classes showed significant and clinically relevant improvements in all HRQoL measures compared with preoperative assessment (p < 0.05). Patients reported improved perception of current overall health status for the EQ VAS. Underweight, overweight, and all obesity classes showed increasingly worse 1-year HRQoL compared with normal weight, both with unadjusted and adjusted calculations.

Conclusions: In this study, we found that all BMI classes had significant improvement in HRQoL at 1 year following THA. Patients who were underweight, overweight, or obese (classes I to III), compared with those of normal weight, reported worse hip pain and EQ-5D-3L and EQ VAS responses prior to THA and at 1 year postoperatively. These results can assist both health-care providers and patients in establishing reasonable expectations about THA outcomes.

Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Place, publisher, year, edition, pages
Lippincott Williams & Wilkins, 2020
National Category
Orthopaedics
Identifiers
urn:nbn:se:umu:diva-178811 (URN)10.2106/JBJS.OA.20.00100 (DOI)33354639 (PubMedID)2-s2.0-85114132348 (Scopus ID)
Available from: 2021-01-18 Created: 2021-01-18 Last updated: 2023-03-23Bibliographically approved
Sayed-Noor, A., Mukka, S., Mohaddes, M., Kärrholm, J. & Rolfson, O. (2019). Body mass index is associated with risk of reoperation and revision after primary total hip arthroplasty: a study of the Swedish Hip Arthroplasty Register including 83,146 patients. Acta Orthopaedica, 90(3), 220-225
Open this publication in new window or tab >>Body mass index is associated with risk of reoperation and revision after primary total hip arthroplasty: a study of the Swedish Hip Arthroplasty Register including 83,146 patients
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2019 (English)In: Acta Orthopaedica, ISSN 1745-3674, E-ISSN 1745-3682, Vol. 90, no 3, p. 220-225Article in journal (Refereed) Published
Abstract [en]

Background and purpose: The prevalence of obesity is on the rise, becoming a worldwide epidemic. The main purpose of this register-based observational study was to investigate whether different BMI classes are associated with increased risk of reoperation within 2 years, risk of revision within 5 years, and the risk of dying within 90 days after primary total hip arthroplasty (THA). We hypothesized that increasing BMI would increase these risks.

Patients and methods: We analyzed a cohort of 83,146 patients who had undergone an elective THA for primary osteoarthritis between 2008 and 2015 from the Swedish Hip Arthroplasty Register (SHAR). BMI was classified according to the World Health Organization (WHO) into 6 classes: < 18.5 as underweight, 18.5-24.9 as normal weight, 25-29.9 as overweight, 30-34.9 as class I obesity, 35-39.9 as class II obesity, and ≥ 40 as class III obesity.

Results: Both unadjusted and adjusted parameter estimates showed increasing risk of reoperation at 2 years and revision at 5 years with each overweight and obesity class, mainly due to increased risk of infection. Uncemented and reversed hybrid fixations and surgical approaches other than the posterior were all associated with increased risk. Obesity class III (≥ 40), male sex, and increasing ASA class were associated with increased 90-day mortality.

Interpretation: Increasing BMI was associated with 2-year reoperation and 5-year revision risks after primary THA where obese patients have a higher risk than overweight or normal weight patients. As infection seems to be the main cause, customizing preoperative optimization and prophylactic measures for obese patients may help reduce risk.

Place, publisher, year, edition, pages
Taylor & Francis Group, 2019
National Category
Orthopaedics
Identifiers
urn:nbn:se:umu:diva-157811 (URN)10.1080/17453674.2019.1594015 (DOI)000464635000001 ()30931664 (PubMedID)2-s2.0-85063633873 (Scopus ID)
Available from: 2019-04-03 Created: 2019-04-03 Last updated: 2023-03-24Bibliographically approved
Al-Amiry, B., Pantelakis, G., Mahmood, S., Kadum, B., Brismar, T. B. & Sayed-Noor, A. S. (2019). Does body mass index affect restoration of femoral offset, leg length and cup positioning after total hip arthroplasty?: a prospective cohort study. BMC Musculoskeletal Disorders, 20, Article ID 422.
Open this publication in new window or tab >>Does body mass index affect restoration of femoral offset, leg length and cup positioning after total hip arthroplasty?: a prospective cohort study
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2019 (English)In: BMC Musculoskeletal Disorders, E-ISSN 1471-2474, Vol. 20, article id 422Article in journal (Refereed) Published
Abstract [en]

Background: In obese patients, total hip arthroplasty (THA) can be technically demanding with increased perioperative risks. The aim of this prospective cohort study is to evaluate the effect of body mass index (BMI) on radiological restoration of femoral offset (FO) and leg length as well as acetabular cup positioning.

Methods: In this prospective study, patients with unilateral primary osteoarthritis (OA) treated with THA between September 2010 and December 2013 were considered for inclusion. The perioperative plain radiographs were standardised and used to measure the preoperative degree of hip osteoarthritis, postoperative FO, leg length discrepancy (LLD), acetabular component inclination and anteversion.

Results: We included 213 patients (74.5% of those considered for inclusion) with a mean BMI of 27.7 (SD 4.5) in the final analysis. The postoperative FO was improper in 55% and the LLD in 15%, while the cup inclination and anteversion were improper in 13 and 23% of patients respectively. A multivariable logistic regression model identified BMI as the only factor that affected LLD. Increased BMI increased the risk of LLD (OR 1.14, 95% CI 1.04 to 1.25). No other factors included in the model affected any of the primary or secondary outcomes.

Conclusion: Increased BMI showed a negative effect on restoration of post-THA leg length but not on restoration of FO or positioning of the acetabular cup. Age, gender, OA duration or radiological severity and surgeon’s experience showed no relation to post-THA restoration of FO, leg length or cup positioning.

Place, publisher, year, edition, pages
BioMed Central (BMC), 2019
Keywords
BMI, Hip arthroplasty, Femoral offset, Leg length discrepancy, Cup positioning
National Category
Radiology, Nuclear Medicine and Medical Imaging
Identifiers
urn:nbn:se:umu:diva-151712 (URN)10.1186/s12891-019-2790-y (DOI)000485277400001 ()31510993 (PubMedID)2-s2.0-85072113263 (Scopus ID)
Available from: 2018-09-10 Created: 2018-09-10 Last updated: 2024-03-04Bibliographically approved
Mukka, S., Sjöholm, P., Chammout, G., Kelly-Pettersson, P., Sayed-Noor, A. & Sköldenberg, O. (2019). External Validity of the HOPE-Trial Hemiarthroplasty Compared with Total Hip Arthroplasty for Displaced Femoral Neck Fractures in Octogenarians. JBJS Open Access, 4(2), 1-7, Article ID e0061.
Open this publication in new window or tab >>External Validity of the HOPE-Trial Hemiarthroplasty Compared with Total Hip Arthroplasty for Displaced Femoral Neck Fractures in Octogenarians
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2019 (English)In: JBJS Open Access, ISSN 2472-7245, Vol. 4, no 2, p. 1-7, article id e0061Article in journal (Refereed) Published
Abstract [en]

Background: Randomized controlled trials (RCTs) are the most reliable way of evaluating the effect of new treatments by comparing them with previously accepted treatment regimens. The results obtained from an RCT are extrapolated from the study environment to the general health care system. The ability to do so is called external validity. We sought to evaluate the external validity of an RCT comparing the results of total hip arthroplasty with those of hemiarthroplasty for the treatment of displaced femoral neck fractures in patients ≥80 years of age.

Methods: This prospective, single-center cohort study included 183 patients ≥80 years of age who had a displaced femoral neck fracture. All patients were screened according to the inclusion and exclusion criteria for an RCT comparing total hip arthroplasty and hemiarthroplasty. The population for this study consisted of patients who gave their informed consent and were randomized into the RCT (consenting group, 120 patients) as well as those who declined to give their consent to participate (non-consenting group, 63 patients). The outcome measurements were mortality, complications, and patient-reported outcome measures. Follow-up was carried out postoperatively with use of a mailed survey that included patient-reported outcome questionnaires.

Results: We found a statistically significant and clinically relevant difference between the groups, with the non-consenting group having a higher risk of death compared with the consenting group. (hazard ratio, 4.6; 95% confidence interval, 1.9 to 11.1). No differences were found between the groups in terms of patient-reported outcome measures or surgical complications.

Conclusions: This cohort study indicates a higher mortality rate but comparable hip function and quality of life among eligible non-consenters as compared with eligible consenters when evaluating the external validity of an RCT in patients ≥80 years of age with femoral neck fracture.

Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Place, publisher, year, edition, pages
JBJS, 2019
National Category
Orthopaedics
Identifiers
urn:nbn:se:umu:diva-161074 (URN)10.2106/JBJS.OA.18.00061 (DOI)2-s2.0-85075343868 (Scopus ID)
Available from: 2019-06-27 Created: 2019-06-27 Last updated: 2023-03-24Bibliographically approved
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ORCID iD: ORCID iD iconorcid.org/0000-0002-0658-1112

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