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Comparison of Metal on Metal Total Hip Arthroplasty and Metal on Metal Total Hip Resurfacing.

NCT04516239 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-03-16

No results posted yet for this study

Summary

The goal of this double-blind prospective randomized study is to compare subjective outcome measures and gait parameters between conventional THA using large diameter femoral heads and total hip resurfacing

Conditions

  • Arthroplasty
  • Replacement
  • Hip

Interventions

DEVICE

THA

Three surgeons performed the surgeries through a posterior surgical approach in both groups. The fascia lata was opened and the gluteus maximus was split in line with its muscle fibers. The short external rotators were released from the greater trochanter. A posterior capsulotomy was performed and the hip dislocated. For the THA, the standard techniques proposed by the manufacturer for insertion of the stem were followed. Neck sleeve adapters and three different prosthetic neck-shaft angles (125, 135, and 145) were available to adjust leg length and femoral offset with the large-diameter head THA system.

DEVICE

HR

Three surgeons performed the surgeries through a posterior surgical approach in both groups. The fascia lata was opened and the gluteus maximus was split in line with its muscle fibers. The short external rotators were released from the greater trochanter. A posterior capsulotomy was performed and the hip dislocated. In the HR group, the capsulotomy was completed circumferentially, and the gluteus tendinous insertion on the femur was released in all men, but only when needed in women, to improve femur mobilization.

Sponsors & Collaborators

  • Ciusss de L'Est de l'Île de Montréal

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2007-09-30
Completion
2020-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04516239 on ClinicalTrials.gov