Comparing cemented and uncemented knee replacements

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.