Status:
ACTIVE_NOT_RECRUITING
Uncemented Tritanium TKR vs Cemented Triathlon TKR
Lead Sponsor:
Royal Devon and Exeter NHS Foundation Trust
Collaborating Sponsors:
University of Exeter
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
50-70 years
Phase:
NA
Brief Summary
The Study aims to investigate whether there is a clinically important difference in peri-articular bone mineral density (BMD) and trabecular bone score (TBS) between patients undergoing two different ...
Detailed Description
There have been many studies published that have shown a reduction in bone density around knee replacements. Exact reasons for this are not fully understood but one theory is that the stresses transmi...
Eligibility Criteria
Inclusion
- Patients undergoing primary TKR at the RD+E Hospital
- Patients must have completed a consent form for the study
- Patients must be prepared to comply with the pre and post-operative investigations, attendance schedule and questionnaire schedule of the study
- If the knee for surgery is suitable for standard condylar TKR components
- The diagnosis is of tricompartmental osteoarthritis of the knee
- Aged 50-70 years at time of surgery
Exclusion
- Refusal to consent to the study
- If the knee for surgery is not suitable for standard condylar TKR.
- Pregnancy
- Prisoners
- A patient known to have substance abuse or psychological disorders that could interfere with their ability to comply with the assessment schedules
- Patients unable to read or understand the patient information leaflet and consent form
- Patients who have a Body Mass Index (BMI) ≥ 38
- Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation
- Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year
- Patient requires bilateral total knee replacements, or has a history of unsuccessful contralateral partial or total knee replacement
- Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device
- Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration
- Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days)
- Patients currently taking bisphosphonate medication or have taken within the previous 10 years
- The presence of peri-articular cysts evident on the pre-operative x-ray such as could compromise the stability at the bone implant interface if the uncemented component is used
- A past history of tibial or femoral osteotomy surgery
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04040764
Start Date
October 15 2019
End Date
June 1 2026
Last Update
February 12 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Devon and Exeter NHS Foundation Trust Hospital
Exeter, Devon, United Kingdom, EX2 5DW