TRabecular Metal Economic and Clinical Knee Trial

Launched by NHS GREATER GLASGOW AND CLYDE · Dec 16, 2020

Keywords

ClinConnect Summary

The TRabecular Metal Economic and Clinical Knee Trial is a study that aims to compare two types of total knee replacements: cemented and uncemented. Researchers want to see if there are differences in how well these procedures work, how satisfied patients are after surgery, and how long the replacements last. They are also looking at whether using uncemented knee replacements could save money for the National Health Service (NHS).

To participate in this trial, individuals aged 65 and older who have osteoarthritis and need a knee replacement may be eligible. This includes those who have one painful knee and a well-functioning replacement in the other knee. Participants will need to give their consent and be willing to attend follow-up appointments after the surgery. It’s important to note that certain health conditions could prevent someone from joining the study, such as significant pain in both knees or other medical issues that might affect recovery. Overall, participants can expect to contribute to important research that could help improve knee replacement options for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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