Minimally invasive surgery in total hip arthroplasty: the two-incision technique versus conventional total hip arthroplasty - a prospective, randomised, controlled trial

Completed

• Conditions: Total hip replacement (THR), arthritis; Musculoskeletal Diseases; Other rheumatoid arthritis

• Registration Number: ISRCTN77525474
• Lead Sponsor: Zimmer, Inc. (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Male or female being 18 years or older
2. Patients meet the criteria for osteoarthritis:
2.1. Pain in hip
2.2. Arthritic changes on radiograph: joint space narrowing femoral/acetabular osteofytes
3. Patients not responding to conservative therapy
4. Written informed consent for study participation

Exclusion Criteria

1. Patients who are mentally impaired and not able to fill in questionnaires
2. Patients who do not know the Dutch language
3. Patients with a body mass index (BMI) of more than 40
4. Patients with skeletal immaturity
5. Patients with a life expectancy of less than 3 years
6. Patients with altered anatomy resulting in impossibility for the MIS procedure, according to the surgeon e.g.:
6.1. Hip dysplasia with high luxation
6.2. Post-traumatic severe anatomy change
6.3. Post-correction osteotomy
7. Patients with extremity amputation
8. Patients with an active malignant disease or current cytostatic treatment
9. Patients who are participating in another trial
10. Known alcohol or drug abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified