Prospective Randomized Study of Cementless vs Cemented UKA (NCT05377450) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prospective Randomized Study of Cementless vs Cemented UKA
United States108 participantsStarted 2022-08-29
Plain-language summary
To evaluate the non-inferiority of the cementless Engage Partial Knee System compared to cemented Engage Partial knee System.
Who can participate
Age range21 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with a pre-operative Knee Society Assessment Score of \<70
* Patients undergoing primary partial knee arthroplasty as unilateral arthroplasty or bilateral arthroplasty, simultaneously or otherwise
* Patients diagnosed with osteoarthritis (Kellgren Lawrence Grade IV) or avascular necrosis limited to the medial compartment of the operative knee joint
* Male or female patients who are at least 21 years of age at the time of surgery
* Patients with full thickness cartilage loss, with or without bone loss in the medial compartment
* Patients with functionally intact ACL and PCL
* Patients who need to obtain relief of pain and/or improved function in their knee
* Patients with fixed flexion deformity \< 15°
* Patients who are able to follow post operative care instructions
* Patients who are willing and able to return for scheduled follow-up evaluations
* Patients in which natural alignment can be restored
* Patients with BMI \< 40
* Patients who have completed a valid, IRB approved Informed Consent Form
Exclusion Criteria:
* Patients with a pre-operative Knee Society Assessment Score of ≥ 70
* Patients in which the device would be used to revise a failed prosthesis
* Patients who are less than 21 years of age at the time of surgery
* Disease or damage to the lateral part of the knee that in the investigator's opinion contraindicates a partial knee replacement
* Patients diagnosed with rheumatoid arthritis or other forms of inflammatory joint disea…