Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty

Frederiksberg University Hospital

Status: Completed

Conditions: Patients Suitable for THA

Treatments: Device: ReCap hip prosthesis; Device: ASR hip prosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT00249054

KF11279577

Details and patient eligibility

About

This evaluation is being conducted to evaluate the performance of the ASR arthroplasty. The performance of the devices will be assessed by:

Clinical parameters: pain, function, satisfaction and complications. Blood samples: Analyse of metal ions, lymphocyte migration, lymphocyte proliferation assay and cytokines.

Biopsies: Metal ions, cytokines and histology. Biomechanics: Strength, gait analysis, range of motion. Scanning: DEXA and MRI

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

ASA I-II,DEXA-scanning:

• lower limit for a 55 years old women,
• MRI normal
• vitality in caput
• willing to return for follow-up evaluations.

Exclusion criteria

• collum femoris < 2 cm
• large cysts in caput (> 1 cm)
• mismatch between caput and acetabulum
• caput necrosis
• treatment with medicine which affects bone metabolism
• impaired kidney function.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

ASR hip prosthesis

Active Comparator group

Description:

DuPuy ASR hip prosthesis

Treatment:

Device: ASR hip prosthesis

Device: ReCap hip prosthesis

ReCap hip prosthesis

Active Comparator group

Description:

Biomet ReCap hip prosthesis

Treatment:

Device: ReCap hip prosthesis