Comparing cemented and uncemented knee replacements
Health Economic and Clinical Comparison of Trabecular Metal Uncemented and Cemented Modular Total Knee Replacements - A Double Blinded Randomised Controlled Trial
This study is testing whether knee replacements that use cement or those that don't lead to better results and satisfaction for patients over the long term.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NHS Greater Glasgow and Clyde Academic / other |
| Locations | 1 site (Glasgow, Scotland) |
| Trial ID | NCT04677907 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare the clinical outcomes, patient satisfaction, and survivorship between cemented and uncemented total knee replacements (TKR). It will involve a randomized controlled design where participants will be assessed using clinical knee scores and the Forgotten Joint Score to evaluate functional ability and patient awareness of their artificial joint. Additionally, Inertial Measuring Units will be used to objectively measure movement and functionality during daily tasks before and after surgery. The study will follow participants over a 10-year period to determine any significant differences in outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals with unilateral or bilateral osteoarthritis of the knee who require a total knee replacement.
Not a fit: Patients with existing conditions that may compromise their participation or follow-up in the study will not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could provide insights into which type of knee replacement offers better long-term outcomes and patient satisfaction.
How similar studies have performed: Other studies have explored similar comparisons between cemented and uncemented knee prostheses, indicating potential for meaningful insights, though this specific approach may offer novel data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Glasgow, Scotland
- Dept of Orthopaedics, Glasgow Royal Infirmary — Glasgow, Scotland, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Mark JG Blyth, Mr — NHS Greater Glasgow and Clyde
- Study coordinator: Mark JG Blyth, Mr
- Email: mark.blyth@ggc.scot.nhs.uk
- Phone: 01412114107
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.