Last updated: April 9, 2024
Sponsor: Sebastiaan van de Groes
Overall Status: Terminated
Phase
N/A
Condition
Orthopedics
Treatment
Conventional procedure; NO onlay patella button
onlay patella button
Clinical Study ID
NCT05824533
4DCT-tracking-TKA
Ages 50-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Non-inflammatory knee osteoarthritis, which is confirmed by radiology.
- Osteoarthritis is unilateral or bilateral with the contralateral knee functioningproperly, not operated on in the last 6 months.
- Set to receive a primary cemented total knee arthroplasty.
- Aged between 50 and 80 years, inclusive, on the day of the operation.
- This age limit of 50 is based on the desire to include exclusively patients withprimary osteoarthritis. As osteoarthritis is an age-related disorder, itgenerally involves adults over the age of 50 years. Patients under the age of 50years who present with osteoarthritis usually have osteoarthritis due to asecondary cause (e.g. post-traumatic osteoarthritis).
- A maximum age of 80 years will be employed. This age limit will be adoptedbecause patients should be well able to perform an extension-flexion movementwhile a dynamic CT scan is made.
- In stable health (American Society of Anesthesiology (ASA)-score ≤ 3) and is free ofor treated for cardiac, pulmonary, haematological, or other conditions that would poseexcessive operative risk.
- Patient has a correctable or <10° rigid (non-correctable) varus deformity of the knee.
- Participants must be able to give informed consent.
- Patient plans to be available for follow-up until two years post-operative.
- Ability to walk for 2 minutes without walking aid
Exclusion
Exclusion Criteria:
- Valgus deformity
- Body MAss Index (BMI) > 35.
- Previous hip /knee/ankle replacement surgery in the last 12 months, or is planned tohave a hip replacement in the next 6-12 months.
- Patient has had major, non-arthroscopic surgery to the study knee, including HighTibial Osteotomy (HTO).
- Patient has an active, local infection or systemic infection
- Incomplete or insufficient tissue surrounding the knee.
- Severe damage to the medial or collateral knee ligaments and popliteal tendon
- Documented osteoporosis with patient in active medical treatment.
- Patient has physical, emotional or neurological conditions that impacts gait orbalance, or would compromise compliance with post-operative rehabilitation andfollow-up.
- Bone quality compromised by disease or infection which cannot provide adequate supportand/or fixation to the prosthesis
- Knee flexion < 90 degrees
- > 30 degrees extension deficit (active restraint to extension)
- Patient does not have a proper functioning patella tendon on the affected side;measured as inability of active extension of the knee
- Patient has active rheumatoid arthritis, any auto-immune disorder, immunosuppressivedisorder or a terminal illness.
Study Design
Total Participants: 5
Treatment Group(s): 2
Primary Treatment: Conventional procedure; NO onlay patella button
Phase:
Study Start date:
April 08, 2022
Estimated Completion Date:
February 21, 2024
Study Description
Connect with a study center
Treant, the Netherlands
Groningen,
NetherlandsSite Not Available
RadboudUMC
Nijmegen,
NetherlandsSite Not Available
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