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

Medial Rotation Knee Randomised Controlled Trial Allpolyethylene versus Metal backed tibia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12532998

Enrollment

150

Registered

2015-04-15

Start date

2015-04-09

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing total knee arthroplasty for any indication. Musculoskeletal Diseases Total knee arthroplasty

Interventions

Participants in the study will all be undergoing total knee arthroplasty, group A will receive the all-polyethylene tibia medial rotation knee implant whereas group B will receive the metal-backed tib

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

England, United Kingdom

Contacts

Public ContactLaura Richards

laura.richards@matortho.com+44 (0)1372 224234

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026