Randomised controlled trial to assess an all-polyethylene tibia medial rotation knee implant compared to a metal-backed tibia implant

Not Applicable

Completed

• Conditions: Patients undergoing total knee arthroplasty for any indication.; Musculoskeletal Diseases; Total knee arthroplasty

• Registration Number: ISRCTN12532998
• Lead Sponsor: MatOrtho Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-15
• Study Completion: 2021-12-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 162

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
6. Sepsis
7. Osteomyelitis
8. Osteomalacia
9. Severe osteoporosis – clinical judgement
10. Metabolic disorders which may impair bone formation
11. Patients lacking capacity to provide consent
12. Those whose prospects for a recovery to independent mobility would be compromised by known pre-existing medical conditions
13. Patients who have their contralateral knee already in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the mean range of motion (ROM) of the all-polyethylene tibia MRK to the metal-backed tibia MRK. A difference of means in ROM of 5 degrees or more will be used to determine if there is a difference in the clinical outcome of the all-polyethylene tibia and the metal-backed tibia.

Secondary Outcome Measures

Name	Time	Method
Patient reported outcome measures will be compared for the two treatment arms, including the Oxford Knee Score, the EQ-5D, Modified Forgotten Joint Score, and the UCLA Activity score.