Dataset Information

Better early functional outcome after short stem total hip arthroplasty? A prospective blinded randomised controlled multicentre trial comparing the Collum Femoris Preserving stem with a Zweymuller straight cementless stem total hip replacement for the treatment of primary osteoarthritis of the hip.

ABSTRACT:

Objectives

Primary aim was to compare the functional results at 3 months and 2 years between short and conventional cementless stem total hip arthroplasty (THA). Secondary aim was to determine the feasibility of a double-blind implant-related trial.

Design

A prospective blinded randomised controlled multicentre trial in patients with osteoarthritis of the hip. All patients, research assistants, clinical assessors, investigators and data analysts were blinded to the type of prosthesis.

Population

150 patients between 18 and 70 years with osteoarthritis of the hip, 75 in the short stem and 75 in the conventional stem group. Mean age: 60 years (SD 7).

Interventions

the Collum Femoris Preserving short stem versus the Zweymuller Alloclassic conventional stem.

Main outcome measures

The Dutch version of the Hip Disability and Osteoarthritis Outcome Score (HOOS). Secondary outcomes measures: Harris Hip Score, the Physical Component Scale of the SF12, the Timed Up and Go test, Pain and the EQ-5D. Feasibility outcomes: continued blinding, protocol adherence and follow-up success rate.

Results

No significant difference between the two groups. Mean HOOS total score in the short stem group increased 32.7 points from 36.6 (95% CI 32.9 to 40.2) preoperatively to 69.3 (95% CI 66.4 to 72.1) at 3 months follow-up. Mean HOOS total score in the conventional straight stem group increased 36.3 points from 37.1 (95% CI 33.9 to 40.3) preoperatively to 73.4 (95% CI 70.3 to 76.4) at 3 months follow-up. 91.2% of patients remained blinded at 2?years follow-up. Both protocol adherence and follow-up success rate were 98%.

Conclusions

Functional result at 3 months and 2 years after short stem THA is not superior to conventional cementless THA. There were more perioperative and postoperative complications in the short stem group. Direct comparison of two hip implants in a double-blinded randomised controlled trial is feasible.

Trial registration number

NTR1560.

SUBMITTER: van Oldenrijk J

PROVIDER: S-EPMC5652481 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Publications

Better early functional outcome after short stem total hip arthroplasty? A prospective blinded randomised controlled multicentre trial comparing the Collum Femoris Preserving stem with a Zweymuller straight cementless stem total hip replacement for the treatment of primary osteoarthritis of the hip.

van Oldenrijk Jakob J Scholtes Vanessa A B VAB van Beers Loes W A H LWAH Geerdink Carel H CH Niers Bob B A M BBAM Runne Wouter W Bhandari Mohit M Poolman Rudolf W RW

BMJ open 20171016 10

<h4>Objectives</h4>Primary aim was to compare the functional results at 3 months and 2 years between short and conventional cementless stem total hip arthroplasty (THA). Secondary aim was to determine the feasibility of a double-blind implant-related trial.<h4>Design</h4>A prospective blinded randomised controlled multicentre trial in patients with osteoarthritis of the hip. All patients, research assistants, clinical assessors, investigators and data analysts were blinded to the type of prosthe ...[more]

PMID: 29042371

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Project description:Mortality related to femoral neck fractures remains a challenging health issue, with a high mortality rate at 1 year of follow-up. Three modifiable factors appear to be under control of the surgeon: the choice of the implant, the use of cement and the timing before surgery. The aim of this research project was to study the impact on mortality each of these risk factors play during the management of femoral neck fractures. A large retrospective epidemiological study was performed using a national database of the public healthcare system. The inclusion criteria were patients who underwent joint replacement surgery after femoral neck fracture during the years 2015 to 2017. All data points were available for at least 2 years after the fracture. The primary outcome was mortality within 2 years following the surgery. We evaluated the association between mortality and the type of the implant hemiarthroplasty (HA) versus total hip arthroplasty (THA), cemented versus non cemented femoral stem as well as the timing from fracture to surgical procedure. A multivariate analysis was performed including age, gender, comorbidities/autonomy scores, social category, and obesity. We identified 96,184 patients who matched the inclusion criteria between 2015 and 2017. 64,106 (66%) patients underwent HA and 32,078 (33.4%) underwent THA. After multivariate analysis including age and comorbidities, patients who underwent surgery after 72 h intra-hospital had a higher risk of mortality: Hazard Ratio (HR) = 1.119 (1.056-1.185) p = 0.0001 compared to the group who underwent surgery within 24 h. THA was found to be a protective factor HR = 0.762 (0.731-0.795) p < 0.0001. The use of cement was correlated with higher mortality rate: HR = 1.107 (1.067-1.149) p < 0.0001. Three key points are highlighted by our study in the reduction of mortality related to femoral neck fracture: the use of hemiarthroplasty a surgery performed after 48 h and the use of cement for femoral stem fixation adversely affect mortality risk.

Project description:BackgroundUnloading of the proximal medial femoral cortex is usually associated with an increased bone strain at the distal part of the prosthesis, which may cause distal femoral cortical hypertrophy (CH). The objective of this study was to determine the factors that may be considered a predisposition to distal femoral CH and its effect on the stress shielding (SS) or durability of the fixation of the stem.MethodsA total of 240 total hip arthroplasties were performed between January 2006 and December 2016, with all hips implanted with a Bicontact stem. The minimum follow-up period was more than 2 years, and the mean follow-up period was 7.2 years. The radiographic outcome was assessed on an anteroposterior hip radiograph. CH and SS were assessed on postoperative radiographs in the Gruen zone. We defined CH that appeared in zone 3 or 5 as 'the focal type' and defined CH that appeared in zones 2, 3, 4, 5, and 6 as 'the diffuse type.' SS followed the procedures from the Engh classification.ResultsCH was found in 72 hips (30% of the 240 hips), the focal type was found in 23 hips (9.6% of the 240 hips), and the diffuse type was found in 49 hips (20.4% of the 240 hips). SS was found in 41 hips (17.1% of 240 hips), including 32 hips with SS, which was found after the development of CH. One hip was from the focal-type CH and 31 hips were from the diffuse-type CH. SS, which is typically found in Engh classification types 1 and 2 developed in 13 hips, and SS, which is widely seen in Engh classification types 3 and 4 developed in 19 hips. All 19 hips with progressed SS were found after the diffuse-type CH had developed. In addition, among the 19 hips with progressed SS, Dorr type A was found in 0 hips, Dorr type B in 8 hips, and Dorr type C in 11 hips.ConclusionsAccording to the results of our radiological evaluation, development of the diffuse-type CH after total hip arthroplasty using Bicontact stems is one of the critical causes of the later development of SS and could be predicted to progress to SS. To prevent the development of the diffuse-type CH, the indication to choose a Bicontact stem for a Dorr type C with osteoporotic bone should be considered.

Project description:Antiresorptive denosumab is known to improve the quality and strength of cortical bone in the proximal femurs of osteoporotic women, but its efficacy in preventing periprosthetic bone loss and reducing femoral stem migration has not been studied in women undergoing cementless total hip arthroplasty. We conducted a single-center, randomized, double-blinded, placebo-controlled trial of 65 postmenopausal women with primary hip osteoarthritis and Dorr type A or B proximal femur anatomy. The patients randomly received subcutaneous injections of denosumab 60?mg or placebo once every 6 months for 12 months, starting 1 month before surgery. The primary endpoint was the change in bone mineral density (BMD) of the proximal femur (Gruen zone 7) at week 48, and the secondary endpoint was stem subsidence measured by radiostereometric analysis (RSA) at week 48. Exploratory endpoints included changes in BMDs of the contralateral hip, lumbar spine and distal radius, serum levels of bone turnover markers, walking speed, walking activity, patient-reported outcome measures, and radiographic assessment of stem osseointegration. The participants underwent vertebral-fracture assessment in an extension safety study at 3 years. Denosumab significantly decreased bone loss in the medial femoral neck (zone 7) and increased periprosthetic BMD in the greater trochanteric region (zone 1) and lesser trochanteric region (zone 6). Denosumab did not reduce temporary femoral stem migration. The migration occurred mainly during the settling period (0 to 12 weeks) after implantation of the prosthesis. All of the stems osseointegrated, as evaluated by RSA and radiographs. There were no intergroup differences in functional recovery. Discontinuation of denosumab did not lead to any adverse events. In conclusion, denosumab increased periprosthetic BMD in the clinically relevant regions of the proximal femur, but the treatment response was not associated with any reduction of initial stem migration. © 2019 The Authors. JBMR Plus published by Wiley Periodicals, Inc. on behalf of the American Society for Bone and Mineral Research.

Project description:Background and purpose - Gait analysis performed under increased physical demand may detect differences in gait between total (THA) versus resurfacing hip arthroplasty (RHA), which are not measured at normal walking speed. We hypothesized that patients after RHA would reach higher walking speeds and inclines compared with THA. Additionally, an RHA would enable a more natural gait when comparing the operated with the healthy contralateral hip. Patients and methods - From a randomized controlled trial comparing THA with RHA with at least 5 years' follow-up patients with a UCLA score of more than 3 points (n = 34) were included for an instrumented treadmill gait analysis. 25 patients with a unilateral implant (primary analysis-16 THA versus 9 RHA) and 9 patients with a bilateral implant (sub-analysis-n = 5 RHA + THA; n = 4 THA + THA). Spatiotemporal parameters, ground reaction forces, and range of motion were recorded at increasing walking speeds and inclines. Functional outcome scores were obtained. Results - At a normal walking speed of 1.1 m/s and at increasing inclines no differences were recorded in gait between the 2 groups with a unilateral hip implant. With increasing walking speed the RHA group reached a higher top walking speed (TWS) (adjusted difference 0.07 m/s, 95% CI -0.11 to 0.25) compared with THA. Additionally, RHA patients tolerated more weight on the operated side at TWS (155 N, CI 49-261) and as such weight-bearing approached the unaffected contralateral side. For the RHA group a "between leg difference" of 8 N (CI 3-245) was measured versus -129 N (CI -138 to -29) for THA (adjusted difference 144 N, CI 20-261). Hip flexion of the operated side at TWS was higher after RHA compared with THA (adjusted difference 8°, CI 1.7-14). Interpretation - In this study RHA patients reached a higher walking speed, and preserved a more normal weight acceptance and a greater range of hip flexion against their contralateral healthy leg as compared with patients with a THA.

Dataset Information

Better early functional outcome after short stem total hip arthroplasty? A prospective blinded randomised controlled multicentre trial comparing the Collum Femoris Preserving stem with a Zweymuller straight cementless stem total hip replacement for the treatment of primary osteoarthritis of the hip.

Objectives

Design

Population

Interventions

Main outcome measures

Results

Conclusions

Trial registration number

Publications

Better early functional outcome after short stem total hip arthroplasty? A prospective blinded randomised controlled multicentre trial comparing the Collum Femoris Preserving stem with a Zweymuller straight cementless stem total hip replacement for the treatment of primary osteoarthritis of the hip.

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