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Clinical Trials/ISRCTN12532998
ISRCTN12532998
Completed
未知

Medial Rotation Knee Randomised Controlled Trial Allpolyethylene versus Metal backed tibia

MatOrtho Limited0 sites162 target enrollmentApril 15, 2015

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.

Registry
who.int
Start Date
April 15, 2015
End Date
December 31, 2021
Last Updated
2 years ago
Study Type
Interventional
Sex
All

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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