ISRCTN12532998
Completed
未知
Medial Rotation Knee Randomised Controlled Trial Allpolyethylene versus Metal backed tibia
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Patients undergoing total knee arthroplasty for any indication.
- Sponsor
- MatOrtho Limited
- Enrollment
- 162
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Primary total knee arthroplasty (for any indication)
- •2\. Informed consent to participate in the study provided by the patient
- •3\. Patients aged over 18 years
- •4\. Able to understand and respond to Patient\-reported outcome measures (PROMs) for the duration of the study period
Exclusion Criteria
- •1\. Severe muscular, neurological or vascular deficiencies which compromise the affected extremity
- •2\. Bone deficiency or deficient bone quality likely to compromise the implant (as determined by surgical team on pre\-operative radiographs)
- •3\. Severe ligament instability
- •4\. Hypersensitivity to the materials used
- •5\. Alcoholism or other addictive disorders
- •7\. Osteomyelitis
- •8\. Osteomalacia
- •9\. Severe osteoporosis – clinical judgement
- •10\. Metabolic disorders which may impair bone formation
- •11\. Patients lacking capacity to provide consent
Outcomes
Primary Outcomes
Not specified
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