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

PHASE4CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

September 30, 2007

Study Completion Date

July 31, 2020

Conditions
ArthroplastyReplacementHip
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.

All Listed Sponsors
lead

Ciusss de L'Est de l'Île de Montréal

OTHER

NCT04516239 - Comparison of Metal on Metal Total Hip Arthroplasty and Metal on Metal Total Hip Resurfacing. | Biotech Hunter | Biotech Hunter