Primary hemiarthroplasty for the elderly patient with cognitive dysfunction and a displaced femoral neck fracture: a prospective, observational cohort study.

BACKGROUND: At least one-third of hip fracture patients have some degree of impaired cognitive status, which may complicate their postoperative rehabilitation. AIM: We aimed to describe the outcome for elderly patients with cognitive dysfunction operated with hemiarthroplasty (HA) for a femoral neck fracture and to study the impact postoperative geriatric rehabilitation has on functional outcome up to 1 year after surgery. METHODS: 98 patients with a displaced femoral neck fracture with a mean age of 86 years were included and followed up to 1 year. The outcomes were hip-related complications and reoperations, the capacity to return to previous walking ability, health-related quality of life, hip function and mortality. RESULTS: The prevalence of hip complications leading to a major reoperation was 6% and the 1-year mortality rate was 31%. The lack of geriatric rehabilitation was correlated with poorer outcomes overall and those who receive geriatric rehabilitation were less likely to be confined to a wheelchair or bedridden at the 1-year follow-up. CONCLUSIONS: Hemiarthroplasty is an acceptable option for elderly patients with a displaced femoral neck fracture and cognitive dysfunction. A lack of structured rehabilitation is associated with a significant deterioration in walking ability despite a well-functioning hip. However, the causality of this could be due to selection bias of healthier patients being sent to geriatric rehabilitation.

External Validity of the HOPE-Trial: Hemiarthroplasty Compared with Total Hip Arthroplasty for Displaced Femoral Neck Fractures in Octogenarians.

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.

HOPE-Trial: Hemiarthroplasty Compared with Total Hip Arthroplasty for Displaced Femoral Neck Fractures in Octogenarians: A Randomized Controlled Trial.

BACKGROUND: The choice of primary hemiarthroplasty or total hip arthroplasty in patients ≥80 years of age with a displaced femoral neck fracture has not been adequately studied. As the number of healthy, elderly patients ≥80 years of age is continually increasing, optimizing treatments for improving outcomes and reducing the need for secondary surgery is an important consideration. The aim of the present study was to compare the results of hemiarthroplasty with those of total hip arthroplasty in patients ≥80 years of age. METHODS: This prospective, randomized, single-blinded trial included 120 patients with a mean age of 86 years (range, 80 to 94 years) who had sustained an acute displaced femoral neck fracture <36 hours previously. The patients were randomized to treatment with hemiarthroplasty (n = 60) or total hip arthroplasty (n = 60). The primary end points were hip function and health-related quality of life at 2 years. Secondary end points included hip-related complications and reoperations, mortality, pain in the involved hip, activities of daily living, surgical time, blood loss, and general complications. The patients were reviewed at 3 months and 1 and 2 years. RESULTS: We found no differences between the groups in terms of hip function, health-related quality of life, hip-related complications and reoperations, activities of daily living, or pain in the involved hip. Hip function, activities of daily living, and pain in the involved hip deteriorated in both groups compared with pre-fracture values. The ability to regain previous walking function was similar in both groups. CONCLUSIONS: We found no difference in outcomes after treatment with either hemiarthroplasty or total hip arthroplasty in active octogenarians and nonagenarians with a displaced femoral neck fracture up to 2 years after surgery. Hemiarthroplasty is a suitable procedure in the short term for this group of patients. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Reduced periprosthetic fracture rate when changing from a tapered polished stem to an anatomical stem for cemented hip arthroplasty: an observational prospective cohort study with a follow-up of 2 years.

Background and purpose - Straight collarless polished tapered stems have been linked to an increased risk for periprosthetic femur fractures in comparison with anatomically shaped stems, especially in elderly patients. Therefore, we evaluated the effect of an orthopedic department's full transition from the use of a cemented collarless, polished, tapered stem to a cemented anatomic stem on the cumulative incidence of postoperative periprosthetic fracture (PPF). Patients and methods - This prospective single-center cohort study comprises a consecutive series of 1,077 patients who underwent a cemented hip arthroplasty using either a collarless polished tapered stem (PTS group, n = 543) or an anatomic stem (AS group, n = 534). We assessed the incidence of PPF 2 years postoperatively and used a Cox regression model adjusted for age, sex, ASA class, cognitive impairment, BMI, diagnosis, and surgical approach for outcome analysis. Results - Mean age at primary surgery was 82 years (49-102), 73% of the patients were female, and 75% underwent surgery for a femoral neck fracture. The PPF rate was lowered from 3.3% (n = 18) in the PTS group to 0.4% (n = 2) in the AS group. The overall complication rate was also lowered from 8.8% in the PTS group to 4.5% in the AS group. In the regression model only cognitive dysfunction (HR 3.8, 95% CI 1.4-10) and the type of stem (PTS vs AS, HR 0.1, CI 0.0-0.5) were correlated with outcome. Interpretation - For elderly patients with poor bone quality use of cemented anatomic stems leads to a substantial reduction in periprosthetic fracture rate without increasing other complications.

More complications with uncemented than cemented femoral stems in total hip replacement for displaced femoral neck fractures in the elderly.

Background and purpose - Total hip replacement (THR) is the preferred method for the active and lucid elderly patient with a displaced femoral neck fracture (FNF). Controversy still exists regarding the use of cemented or uncemented stems in these patients. We compared the effectiveness and safety between a modern cemented, and a modern uncemented hydroxyapatite-coated femoral stem in patients 65-79 years of age who were treated with THR for displaced FNF. Patients and methods - In a single-center, single-blinded randomized controlled trial, we included 69 patients, mean age 75 (65-79) and with a displaced FNF (Garden III-IV). 35 patients were randomized to a cemented THR and 34 to a reverse-hybrid THR with an uncemented stem. Primary endpoints were: prevalence of all hip-related complications and health-related quality of life, evaluated with EuroQol-5D (EQ-5D) index up to 2 years after surgery. Secondary outcomes included: overall mortality, general medical complications, and hip function. The patients were followed up at 3, 12, and 24 months. Results - According to the calculation of sample size, 140 patients would be required for the primary endpoints, but the study was stopped when only half of the sample size was included (n = 69). An interim analysis at that time showed that the total number of early hip-related complications was substantially higher in the uncemented group, 9 (among them, 3 dislocations and 4 periprosthetic fractures) as compared to 1 in the cemented group. The mortality and functional outcome scores were similar in the 2 groups. Interpretation - We do not recommend uncemented femoral stems for the treatment of elderly patients with displaced FNFs.

Cemented compared to uncemented femoral stems in total hip replacement for displaced femoral neck fractures in the elderly: study protocol for a single-blinded, randomized controlled trial (CHANCE-trial).

BACKGROUND: Total hip replacement (THR) is the preferred method for the active and lucid elderly patient with a displaced femoral neck fracture (FNF). But controversy still exists regarding using cemented or uncemented stem in these patients. The aim of this study is to compare a cemented and uncemented femoral stem in patients 65-79 years treated surgically with THR for displaced FNF. METHODS/DESIGN: In a single-centre, single-blinded, randomized controlled trial, we will include 140 patients aged 65-79 years with an acute displaced FNF and randomize them in a 1:1 ratio to a cemented tapered or a uncemented tapered hydroxyapatite - coated femoral stem. A cemented cup will be used in both groups. The patients will be blinded for allocation. The primary endpoints will be the incidence of all hip-related complications and health-related quality of life evaluated with EuroQol-5D (EQ-5D) index up to 2 years after surgery. Secondary outcomes will be overall mortality, general medical complications and hip function. The follow-up will be at 3 months, 1 and 2 years. Further follow-ups after end of study will be at 4 and 10 years. Results will be analysed using 95 % CI's for the effect size. A regression model will also be used to adjust for stratification factor. DISCUSSION: The ethical committee at Karolinska Institutet has approved the study. An interim analysis on the primary endpoints will be performed when half the sample size is included. The results from the study will be disseminated to the medical community via presentations and publications in relevant medical journals. The study will provide evidence if a cemented or uncemented femoral stem is preferable in THR for elderly patients with a displaced FNF. TRIAL REGISTRATION: The trial is registered at clinicaltrials.gov ( NCT02247791 ), October 21, 2013.

Migration and head penetration of Vitamin-E diffused cemented polyethylene cup compared to standard cemented cup in total hip arthroplasty: study protocol for a randomised, double-blind, controlled trial (E1 HIP).

INTRODUCTION: In vitro, Vitamin-E-diffused, highly cross-linked polyethylene (PE) has been shown to have superior wear resistance and improved mechanical properties when compared to those of standard highly cross-linked PE liners used in total hip arthroplasty (THA). The aim of the study is to evaluate the safety of a new cemented acetabular cup with Vitamin-E-doped PE regarding migration, head penetration and clinical results. METHODS AND ANALYSIS: In this single-centre, double-blinded, randomised controlled trial, we will include 50 patients with primary hip osteoarthritis scheduled for THA and randomise them in a 1:1 ratio to a cemented cup with either argon gas-sterilised PE (control group) or Vitamin-E-diffused PE (vitamin-e group). All patients and the assessor of the primary outcome will be blinded and the same uncemented stem will be used for all participants. The primary end point will be proximal migration of the cup at 2 years after surgery measured with radiostereometry. Secondary end points include proximal migration at other follow-ups, total migration, femoral head penetration, clinical outcome scores and hip-related complications. Patients will be followed up at 3 months and at 1, 2, 5 and 10 years postoperatively. RESULTS: Results will be analysed using 95% CIs for the effect size. A regression model will also be used to adjust for stratification factors. ETHICS AND DISSEMINATION: The ethical committee at Karolinska Institutet has approved the study. The first results from the study will be disseminated to the medical community via presentations and publications in relevant medical journals when the last patient included has been followed up for 2 years. TRIAL REGISTRATION NUMBER: NCT02254980.

HOPE-trial: hemiarthroplasty compared to total hip arthroplasty for displaced femoral neck fractures in the elderly-elderly, a randomized controlled trial.

BACKGROUND: A femoral neck fracture (FNF) is a common cause of suffering and premature death in the elderly population. Optimizing the treatment for improved outcome and a reduced need for secondary surgery is important both for the patient and the society. The choice of primary total or hemiarthroplasty in patients over eighty years are controversial. We hypothesized that total hip arthroplasty has an equal or better outcome in patient-reported outcome compared with hemiarthroplasty. METHODS/DESIGN: A prospective, randomized, single-blinded trial will be conducted. We will include 120 patients, 80 years of age and over with an acute (<36 h) displaced femoral neck fracture. The patients will be randomized in a 1:1 ratio to either total hip arthroplasty or hemiarthroplasty. The primary endpoints are Harris hip Score and EQ-5D. Secondary endpoints include pain measured with visual analogue scale, surgical time, reoperations, complications and radiological measurement of erosion in patients operated with hemiarthroplasty. Follow-up will be performed postoperatively after three months, 1, 2, 4 and 10 years. DISCUSSION: To our knowledge, this is the first randomized controlled trial comparing total hip arthroplasty and hemiarthroplasty for displaced femoral neck fracture in patients age 80 years and over. TRIAL REGISTRATION: Clinicaltrial.gov: NCT02246335.

Vitamin-E diffused highly cross-linked polyethylene liner compared to standard liners in total hip arthroplasty. A randomized, controlled trial.

PURPOSE: We hypothesized that a vitamin E-treated polyethylene articulating liner had lower femoral head penetration than a conventional liner. METHODS: Fifty-one patients with primary hip osteoarthritis were randomized to an uncemented cup with either vitamin E-treated highly cross-linked polyethylene (HXLPE) (vitamin-e group, n = 25) or a standard HXLPE liner (control group, n = 26) and followed for two years after surgery. The outcome variable was polyethylene (PE) linear head penetration, measured with radiostereometry (RSA). RESULTS: The head penetration in x- (medial/lateral) and y- (vertical) axes was significantly lower for the vitamin E-treated liner up to two years with a mean difference between the groups of 0.10 mm (95 % CI 0.04-0.18) and 0.08 mm (95 % CI 0.01-0.15), respectively. The initial total penetration was lower for the vitamin-E group but did not reach statistical significance at two years with a mean difference between the groups of 0.07 mm (95 % CI -0.001 to 0.15, p = 0.09). We found no differences in clinical outcome between the groups. CONCLUSIONS: In this prospective, randomized, controlled trial on a new vitamin-E diffused HXLPE liner we found, compared to a conventional HXLPE liner, lower initial head penetration and lower superior and medial wear. A longer follow-up than two years is necessary to demonstrate lower overall head penetration in vitamin-E liners compared to contemporary highly cross-linked PE.

Porous titanium construct cup compared to porous coated titanium cup in total hip arthroplasty. A randomised controlled trial.

PURPOSE: The purpose of this study was to determine if a new titanium cup with increased porosity resulted in different periacetabular bone loss and migration compared to a porous coated cup. METHODS: Fifty-one patients with primary hip osteoarthritis were randomized to either a cup with porous titanium construct backside (porous titanium group, n = 25) or a conventional porous coated titanium cup (control group, n = 26). The primary outcome variable was change in periacetabular bone mineral density two years after surgery measured with dual energy X-ray absorptiometry (DXA). Secondary outcomes were implant fixation measured with radiostereometry (RSA) and clinical outcome scores. RESULTS: The pattern of bone remodelling was similar in the two groups with almost complete restoration to baseline values. BMD diminished in the two proximal zones and increased in the two distal zones. After minimal migration up to six months all implants in both groups became stable. We found no difference between the two groups in clinical outcome scores. CONCLUSIONS: In this prospective, randomized, controlled trial on a new porous titanium cup we found, compared to the control group, no clinically relevant differences regarding periacetabular bone preservation, implant fixation or clinical outcome up to two years postoperatively.

Total hip replacement versus open reduction and internal fixation of displaced femoral neck fractures: a randomized long-term follow-up study.

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 three months 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. LEVEL OF EVIDENCE: Therapeutic Level I.