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Problems with the Rotaflex: a 10 year review of a rotating hinge prosthesis
H G David1, M Bishay, E T James
1Department of Orthopaedic Surgery, Morriston Hospital, Swansea, Wales, England.
The Journal of Arthroplasty
|June 30, 1998
Summary
The Rotaflex total knee prosthesis shows a high complication rate, with frequent loosening, fracture, and implant failure. This review suggests the prosthesis should not be used due to its poor outcomes.
Area of Science:
- Orthopedic surgery
- Biomedical engineering
- Prosthetic device research
Background:
- The Rotaflex total knee prosthesis is a medical device designed for knee replacement.
- Long-term outcomes of prosthetic devices are crucial for patient care and device development.
Purpose of the Study:
- To present the 10-year review results of the Rotaflex total knee prosthesis.
- To evaluate the long-term efficacy and complication rates of the Rotaflex prosthesis.
Main Methods:
- A 10-year retrospective review of patients who received the Rotaflex total knee prosthesis.
- Analysis of implant complications, including loosening, fracture, and extensor mechanism damage.
- Assessment of subsequent surgical interventions and patient outcomes.
Main Results:
- High frequency of complications: loosening, fracture, and extensor mechanism damage.
- Significant revision surgeries: 4 arthrodesis and 2 amputations among 25 implants.
- Poor outcomes for remaining patients: 7 of 19 required bracing, 13 had poor surgical results.
Conclusions:
- The Rotaflex total knee prosthesis exhibits an overall complication rate approaching 80%.
- The study indicates a lack of place for this prosthesis in current orthopedic practice.
- Concerns regarding device failure and patient morbidity warrant caution.