TRabecular Metal Economic and Clinical Knee Trial

Recruiting now · Not applicable

Conditions studied: Total Knee Replacement, Orthopedics

In brief

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 economic implications of using uncemented TKRs in the NHS?

Key facts

Study ID

NCT04677907

Run by

NHS Greater Glasgow and Clyde

People needed

144

Starts

2022-05-10

Expected to finish

2035-06-30

Last updated by the study team

2025-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dept of Orthopaedics, Glasgow Royal Infirmary — Glasgow, Scotland, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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