Status:
COMPLETED
An RSA and DEXA Study on Migration of Proximal Interphalangeal (PIP) Joint Prostheses of the Hand
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
Zimmer Biomet
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the early migration and the periprosthetic bone changes of cemented versus non-cemented interphalangeal implants using Roentgen stereophotogrammetric analysis a...
Detailed Description
There is a large patient group with primary osteoarthritis (OA) and secondary osteoarthritis due to joint-associated fractures, repeated trauma to the joint and surroundings, congenital joint-deformit...
Eligibility Criteria
Inclusion
- Patients with osteoarthrosis of the PIP joints.
- Patients with sufficient bone quality for implantation of a non-cemented prosthesis. This is estimated by the surgeon preoperatively.
- Informed written patient consent.
- Patients must read and understand Danish.
Exclusion
- Patients with neuromuscular or vascular diseases in the affected upper extremity.
- Patients who, preoperatively, are found to have unsuitable bone quality for un-cemented arthroplasty fixation, for instance bone cysts not visible on x-ray.
- Patients who cannot refrain from taking non-steroidal anti-inflammatory drugs (NSAIDs) postoperatively including cox-2 inhibitors.
- Patients with previously diagnosed osteoporosis.
- Women who are pregnant or are at risk of getting pregnant during the time of investigation.
- Patients with rheumatoid arthritis.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00175188
Start Date
June 1 2004
End Date
October 1 2010
Last Update
October 13 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Orthopaedic Center, Aarhus University Hospital
Aarhus, Denmark, 8000