ISRCTN77525474
Completed
Not Applicable
Minimally invasive surgery in total hip arthroplasty: the two-incision technique versus conventional total hip arthroplasty - a prospective, randomised, controlled trial
Zimmer, Inc. (USA)0 sites110 target enrollmentJanuary 9, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Zimmer, Inc. (USA)
- Enrollment
- 110
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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