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Aspects on treatment of femoral neck fractures: studies on treatment methods, surgical approach and external validity
Umeå University, Faculty of Medicine, Department of Surgical and Perioperative Sciences, Orthopaedics.
2015 (English)Doctoral thesis, comprehensive summary (Other academic)Alternative title
Aspekter på behandling av lårbensfrakturer (Swedish)
Abstract [en]

Femoral neck fracture (FNF) is a great challenge for today´s health care and is associated with high mortality and morbidity in the elderly.  In the short term several studies in the literature have demonstrated improved hip function, quality of life and fewer re-operations in elderly patients treated with total hip arthroplasty (THA) instead of internal fixation (IF). There are few reports on the long-term outcome comparing IF and THA. The vast majority of orthopaedic departments in Sweden use the direct lateral (DL) or posteriolateral (PL) approaches for hip arthroplasty. The PL approach has been linked to an increased risk of dislocation of the prosthesis and a higher rate of revision surgery in comparison to the DL approach. There are few reports focusing on radiological risk factors for prosthetic dislocation and patient reported hip function comparing the two surgical approaches for hip arthroplasty in FNF.

The randomized controlled trial (RCT) is the gold standard for evaluating medical or surgical interventions. An RCT of high quality has to be internally and externally valid. Internal validity refers to a correct study design to avoid bias skewing the results. External validity (EV) refers to whether the results will be clinically relevant to a definable group of patients and can be extrapolated to the general health care situation. There are only a few reports in the orthopaedic literature focusing on the EV of published studies and none in the field of hip fractures.

Study I: This is a RCT of 100 patients with a displaced FNF comparing THA and IF. Follow-up evaluations were performed at three months and 1, 2, 4, 11 and 17 years. It was found that the Harris hip score (HHS) was higher and the rate of reoperations lower for patients treated with THA.

Study II: This is a prospective cohort study of 185 hips, comparing the DL and the PL approaches in patients treated with a hemiarthroplasty (HA) for a displaced FNF. Follow-up was after 1 year. There was no difference in patient reported outcome between the groups measured with the HHS and WOMAC index. The PL approach resulted in a higher re-operation rate while the DL approach in a higher incidence of limping.

Study III: This is a retrospective cohort study of 373 patients with a cemented bipolar HA using a PL approach for a FNF with a follow-up ranging from 6 months to 7 years. Radiographs and all surgical records were reviewed regarding femoral offset (FO), leg length discrepancy (LLD) and Wiberg angle. Patients with recurrent dislocations had a decreased postoperative FO, LLD and shallower acetabulum on the operated side compared with their controls.

Study IV: This is a prospective cohort study of 840 hips comparing patients included in a RCT with those that did not give their informed consent (NC) or did not fulfill the criteria for participating in the trial (MS). Patients in the NC and MS groups had an increased mortality rate in comparison to those included in the study. We did not find any differences in hip function between these groups.

The main conclusions of this thesis are:

  • Healthy and lucid elderly patients with good hip function preoperatively, should be treated with THA for a displaced FNF.
  • The DL approach is favourable in treating displaced FNF with HA due to its decreased risk of reoperation but with an identical hip function outcome as the PL approach.
  • Care should be taken to restore the LLD and FO otherwise this may increase the risk of recurrent dislocation of a HA.
  • Our findings suggest that trial participants had a lower mortality rate than non-participants but the functional outcome of non-participants appeared to be satisfactory. This is important to take into consideration when extrapolating study results to a health care system.
Abstract [sv]

Lårbenshalsfrakturer (FNF) är en utmaning för dagens sjukvård och förknippad med hög mortalitet i den äldre befolkningen. FNF orsakas främst av lågenergitrauma efter fall i samma plan hos patienter med benskörhet. Total höftledsprotes (THA) har visat sig ge en bättre höftfunktion, livskvalitet med färre omoperationer hos äldre patienter än sluten reposition samt fixering med skruvar (IF) under de första två-fyra åren efter operation. Få studier har publicerats med långtidsuppföljning av THA jämfört med IF.

Vid behandling av felställd FNF med halv höftledsplastik (HA) eller THA finns olika kirurgiska metoder (snittföring) för implantation av protesen. Majoriteten av ortopedkliniker i Sverige använder direkt lateral (DL) eller posteriolateral (PL) snittföring. PL har kopplats till en ökad risk för luxation av protesen (urledsvridning), vilket i sin tur genererat en högre risk för omoperation jämfört med DL. Få studier har utvärderat höftfunktion med avseende på snittföring. Detsamma gäller vilka radiologiska faktorer som påverkar risken förprotesluxation. Det finns olika typer av studiedesigner för utvärdering av medicinska och kirurgiska behandlingsmetoder. Studiedesignen med högst bevisvärde anses vara den randomiserade kontrollerade studien (RCT). För att en RCT skall hålla hög kvalitet krävs intern och extern validitet. Intern validitet syftar på ett korrekt studieupplägg som mäter det som avses och undviker påverkan av icke önskvärda faktorer. Extern validitet (EV) innebär att erhållna resultat från studien är generaliserbara och kan extrapoleras till andra grupper än den studerade. Det inga rapporter i ortopediska litteraturen med fokus på EV med patienter som drabbats av FNF.

Studie I: Prospektiv randomiserad studie av 100 patienter med en felställd FNF jämförs THA med IF med avseende på höftfunktion och reoperationer. Uppföljning gjordes efter tre månader samt 1, 2, 4, 11 och 17 år. HHS som mått på höftfunktion var högre och andelen reoperationer lägre för patienter som behandlades med THA.

Studie II: Prospektiv kohortstudie med 183 patienter med felställd FNF behandlade med HA och antingen DL eller PL. Vi fann ingen skillnad i patientrapporterad höftfunktion utvärderat med HHS och WOMAC efter 1 år men en ökad förekomst av hälta vid DL.

Studie III: Retrospektiv kohortstudie av 373 patienter opererade med en cementerad bipolär HA och PL. Postoperativa röntgenbilder granskades avseende femoral offset (FO), postoperativ benlägdsskillnad (LLD) samt acetabulär Wibergvinkel och relaterades till återkommande protesluxationer. Detta relaterades till återkommande luxationer. Uppföljningstiden varierade mellan 6 månader och 7 år. Patienter med återkommande luxationer hade en minskad postoperativ global FO, förkortad LLD och grundare acetabulum på den opererade sidan jämfört med kontroller.

Studie IV: Prospektiv kohortstudie av 840 patienter med felställd FNF där patienter som ingick i en RCT jämförs med de som inte gav sitt samtycke för deltagande eller ej inkluderats i screeningprocessen. De patienterna som inte gav sitt samtycke hade ökad dödlighet, men ingen skillnad i höftfunktion jämfört med deltagare.

Slutsatser

• Friska och kognitivt vitala äldre patienter med god höftfunktion innan en felställd lårbenshalsfraktur bör behandlas med total höftledsprotes.

• DLsnittföring ger ett lika bra patientrapporterad höftfunktion men en ökad förekomst av hälta jämfört med PL snitt vid behandling med halvprotes på grund av en felställd lårbenshalsfraktur.

• Ansträngning bör göras för att återställa benlängdsskillnad samtfemoral offset och därigenom minska risken för återkommande luxation.

• Våra resultat tyder på att patienter som deltar i en randomiserad studie har lägre dödlighet än patienter som avböjt att delta samt de som missats i screeningprocessen. Det är viktigt att ta hänsyn till när extrapolerar studieresultat till ett hälso-och sjukvårdssystem. Detta bör vägas in i värderingen av studieresultatens externa validitet.

Place, publisher, year, edition, pages
Umeå: Umeå Universitet , 2015. , 97 p.
Series
Umeå University medical dissertations, ISSN 0346-6612 ; 1737
Keyword [en]
Hip fracture, femoral neck fracture, treatment, total hip arthroplasty, hemiarthroplasty, internal fixation, surgical approach, outcome, dislocation, femoral offset, leg length discrepancy, external validity
National Category
Orthopedics
Research subject
Orthopaedics
Identifiers
URN: urn:nbn:se:umu:diva-108269ISBN: 978-91-7601-305-2 (print)OAI: oai:DiVA.org:umu-108269DiVA: diva2:852061
Public defence
2015-10-09, Aulan, Länssjukhuset Sundsvall-Härnösand, Lasarettsvägen 21, 856 43, Sundsvall, 09:00 (Swedish)
Opponent
Supervisors
Available from: 2015-09-08 Created: 2015-09-07 Last updated: 2015-10-13Bibliographically approved
List of papers
1. Total hip replacement versus open reduction and internal fixation of displaced femoral neck fractures: a randomized long-term follow-up study
Open this publication in new window or tab >>Total hip replacement versus open reduction and internal fixation of displaced femoral neck fractures: a randomized long-term follow-up study
Show others...
2012 (English)In: Journal of Bone and Joint Surgery. American volume, ISSN 0021-9355, E-ISSN 1535-1386, Vol. 94, no 21, 1921-1928 p.Article in journal (Refereed) Published
Abstract [en]

Background: Clinical trials with short and intermediate-term follow-up have demonstrated superior results for total hip replacement as compared with internal fixation with regard to hip function and the need for secondary surgery in elderly patients with a displaced intracapsular femoral neck fracture. The aim of the present study was to compare the results of total hip replacement with those of internal fixation over a long-term follow-up period of seventeen years.

Methods: We enrolled 100 patients who had sustained a femoral neck fracture in a single-center, randomized controlled trial; all patients had had a healthy hip before the injury. The study group included seventy-nine women and twenty-one men with a mean age of seventy-eight years (range, sixty-five to ninety years). The subjects were randomly assigned to either total hip replacement (the arthroplasty group) (n = 43) or internal fixation (the control group) (n = 57). The primary end point was hip function, evaluated with use of the Harris hip score. Secondary end points included mortality, reoperations, gait speed, and activities of daily life. Follow-up evaluations were performed at threemonths and at one, two, four, eleven, and seventeen years.

Results: The Harris hip score was higher in the total hip arthroplasty group, with a mean difference of 14.7 points (95% confidence interval, 9.2 to 20.1 points; p < 0.001 [analysis of covariance]) during the study period. We found no difference in mortality between the two groups. Four patients (9%) in the total hip replacement group and twenty-two patients (39%) in the internal fixation group had undergone a major reoperation (relative risk, 0.24; 95% confidence interval, 0.09 to 0.64). The overall reoperation rate was 23% (ten of forty-three) in the total hip replacement group and 53% (thirty of fifty-seven) in the internal fixation group (relative risk, 0.44; 95% confidence interval, 0.24 to 0.80). The results related to gait speed and activities of daily living favored the arthroplasty group during the first year.

Conclusions: Over a period of seventeen years in a group of healthy, elderly patients with a displaced femoral neck fracture, total hip replacement provided better hip function and significantly fewer reoperations compared with internal fixation without increasing mortality.

Place, publisher, year, edition, pages
Journal of Bone and Joint Surgery, 2012
Keyword
controlled trial, arthroplasty, femur, index, hemiarthroplasty, dislocation, arthritis, register, alloy, score
National Category
Orthopedics
Identifiers
urn:nbn:se:umu:diva-60112 (URN)10.2106/JBJS.K.01615 (DOI)000310761400001 ()
Available from: 2012-10-01 Created: 2012-10-01 Last updated: 2017-12-07Bibliographically approved
2. Direct lateral versus posterolateral approach to hip hemiarthroplasty for femoral neck fractures: a prospective cohort study
Open this publication in new window or tab >>Direct lateral versus posterolateral approach to hip hemiarthroplasty for femoral neck fractures: a prospective cohort study
Show others...
(English)Article in journal (Refereed) Submitted
Abstract [en]

Background: Adopting the direct lateral (DL) instead of the posterolateral (PL) approach to thehip for femoral neck fractures (FNF) results in a lower rate of prosthetic dislocation. The aim ofthis study was to compare hip function and complications after hemiarthroplasty (HA) by eitherthe DL or the PL approach for a FNF.

Methods: In a prospective cohort study, we enrolled 185 hips (183 patients, 128 women, medianage 84 years) with a displaced FNF. Subjects were, by the surgeons’ preference, assigned totreatment using DL (n=102) or PL approach (n=83) with a HA. Outcomes were Harris hip score(HHS), WOMAC, pain numeric rating scale (PNRS) for pain, limp, mortality and hipcomplications. Patients were followed-up after 1 year.

Results: The HHS was 71 (SD 18) in the DL group and 72 (±17) in the PL group (p=0.59). Wefound no difference in HHS, WOMAC, PNRS and mortality. Seven patients (6.9%) in the DLgroup and 11 patients (13.3%) in the PL group had undergone a major re-operation (adjusted OR0.51; 95% CI, 0.18-2.07; p=0.23). The DL approach was associated with an increased frequencyof patient reported limp (adjusted OR 2.97,1,32-6.67;p=0.008).

Interpretation: In this prospective cohort study, patients treated with HA for FNF using either theDL or PL approaches had comparable functional outcome after 1 year. The PL approach had ahigher re-operation rate while the DL approach had a higher incidence of limp.

National Category
Surgery
Identifiers
urn:nbn:se:umu:diva-108606 (URN)
Available from: 2015-09-14 Created: 2015-09-14 Last updated: 2015-10-28
3. Dislocation of bipolar hip hemiarthroplasty through a postero-lateral approach for femoral neck fractures: A cohort study
Open this publication in new window or tab >>Dislocation of bipolar hip hemiarthroplasty through a postero-lateral approach for femoral neck fractures: A cohort study
Show others...
2015 (English)In: International Orthopaedics, ISSN 0341-2695, E-ISSN 1432-5195, Vol. 39, no 7, 1277-1282 p.Article in journal (Refereed) Published
Abstract [en]

Purpose To analyze postoperative global femoral offset (FO), leg length discrepancy (LLD) and Wiberg angle as risk factors for prosthetic dislocation after treatment with bipolar hemiarthoplasty (HA) through a postero-lateral approach for femoral neck fracture (FNF). Methods Three hundred and seventy three patients treated with a cemented bipolar HA through a postero-lateral approach between January 2006 and December 2013 were included in a cohort study with a follow-up time ranging from 6 months to 7 years. Radiographs and all surgical records were reviewed regarding Global FO, LLD and Wiberg angle. We compared stable hips without dislocation to those with either a single dislocation and those with recurrent instability. Results Three hundred and twenty eight hips fulfilled the inclusion criteria and were analyzed in the study. The incidence of prosthetic dislocation was 10.7 % (36/373). The mean time from surgery to first dislocation was 3.9 months (0-47) and 62.5 % had recurrent dislocations. Patients with dislocation had a statistically significantly decreased postoperative global FO (-6.4 mm vs. -2.8 mm, p = 0.04), LLD (-2 vs. 1.5 mm, p = 0.03) and smaller Wiberg angle (40A degrees vs. 46A degrees, p = 0.01) on the operated side compared with the rest of cohort. In comparison to age and sex-matched control groups from the cohort, the difference in the radiographic parameters were significant in patients with recurrent dislocations but not in patients with a single dislocation. Conclusion Patients with recurrent dislocations had a decreased postoperative global FO, shorter leg and shallower acetabulum on the operated side compared with their controls. These factors might decrease the soft-tissue tension around the operated hip and predispose to dislocation.

Keyword
Femoral neck fracture, Hemiarthroplasty, Femoral offset, Leg length, Discripancy, Dislocation
National Category
Orthopedics
Identifiers
urn:nbn:se:umu:diva-106562 (URN)10.1007/s00264-014-2642-1 (DOI)000356809900004 ()25557759 (PubMedID)
Available from: 2015-07-20 Created: 2015-07-20 Last updated: 2017-12-04Bibliographically approved
4. External validity of a randomized controlled trial in patients with femoral neck fracture
Open this publication in new window or tab >>External validity of a randomized controlled trial in patients with femoral neck fracture
(English)Manuscript (preprint) (Other academic)
Abstract [en]

Background: Randomized clinical trials (RCT) are the most reliable way to evaluate theeffect of treatments by comparing them to previously accepted treatment regimes. The resultsobtained from a RCT are extrapolated from the study environment to the general health caresystem. This parameter is called external validity. The present study we sought to evaluatethe external validity of an RCT comparing the results of total hip arthroplasty tohemiarthroplasty in displaced femoral neck fracture in patients 80 years of age and above.

Methods: In a prospective cohort study, 267 patients (76% females, mean age 87 [SD] 4.7years) were included in the cohort study. All were screened according to the inclusion andexclusion criteria to be included in a RCT comparing total hip arthroplasty andhemiarthoplasty. Those who gave their informed consent and were randomized (RCT group,92 patients), those that were asked to participate in the RCT but would not give theirinformed consent (Non-consenters group, 54 patients) and all patients missed in the screeningprocess (Missed screening group, 121 patients). The primary end point was hip functionevaluated with Harris hip score at 1 year. Secondary end points included quality-of-lifeevaluated with EQ-5D mortality and hip re-operations. Follow up was performed at 1 yearpostoperatively by a mailed survey including patient reported outcome.

Results: We did not find any difference between the groups regarding HHS and EQ-5D, alsowhen adjusting for confounders. There was a statistically significant difference between thethree groups (p=0.047) as the Non-consenter group had a higher risk of death than thoseincluded (HR 2.06, 95% Cl 1.13 to 3.75). The rate of reoperation was lower in the MS groupcompared to the RCT and NC groups (4.1% vs 7.6% vs 9.3%). This difference did not reachstatistical significance when adjusting for confounders

Interpretation: This cohort study indicates a higher mortality rate but comparable hip functionand quality-of-life among eligible non-consenters compared to eligible consenters whenevaluating the external validity of a RCT patients with femoral neck fracture age 80 andabove.

National Category
Surgery
Identifiers
urn:nbn:se:umu:diva-108602 (URN)
Available from: 2015-09-14 Created: 2015-09-14 Last updated: 2015-09-14

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