Status:
RECRUITING
TRabecular Metal Economic and Clinical Knee Trial
Lead Sponsor:
NHS Greater Glasgow and Clyde
Collaborating Sponsors:
Zimmer Biomet
University of Strathclyde
Conditions:
Total Knee Replacement
Orthopedics
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To compare the differences, if any, in clinical outcome, patient satisfaction and survivorship between cemented and uncemented Total Knee Replacements (TKR)? To investigate if there are health economi...
Detailed Description
The investigators propose to undertake a randomised controlled trial comparing Trabecular metal uncemented TKR with cemented TKR. The primary aim will be to determine whether there is a clinically sig...
Eligibility Criteria
Inclusion
- Male or female subjects may be recruited to the evaluation.
- Age - there are no restrictions relating to age of the patient.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects who in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigation procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects with uni-lateral osteoarthritis of the knee or subjects with bi-lateral osteoarthritis of the knee, who have a well functioning and pain free knee replacement in the contralateral knee.
- Subjects who require a TKR for surgical management of osteoarthritis
Exclusion
- Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in the study.
- Patients with bi-lateral disease that significantly impacts on their current function and pain.
- Patients who require revision knee arthroplasty surgery.
- Disorders of the feet, ankles, hips or spine causing significant abnormal gait or significant pain.
- Neurological conditions affecting movement.
- Patients with a pathology, which, in the opinion of the Chief Investigator, will adversely affect healing.
- Patients with other disorders which, in the opinion of the Chief Investigator, will/could impair rehabilitation.
- Subjects who in the opinion of the study investigator are unlikely to comply with the study follow-up protocol
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2035
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04677907
Start Date
May 10 2022
End Date
June 30 2035
Last Update
June 25 2025
Active Locations (1)
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1
Dept of Orthopaedics, Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom, G31 2ER