Prospective Randomized Study of Cementless vs Cemented UKA

Running, not enrolling · Not applicable

Conditions studied: Osteoarthritis, Knee

In brief

To evaluate the non-inferiority of the cementless Engage Partial Knee System compared to cemented Engage Partial knee System.

Key facts

Study ID

NCT05377450

Run by

JIS Research Institute

People needed

108

Starts

2022-08-29

Expected to finish

2025-05-01

Last updated by the study team

2025-03-26

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 disease
• Patients diagnosed with a failed upper tibial osteotomy in the operative knee
• Patients diagnosed with post-traumatic arthritis after tibial plateau fracture
• Patients who have had a patellectomy
• Patients with a flexion deformity > 15°
• Patients with a fixed varus deformity > 15°
• Patients who have rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
• Patients with a fused knee on operative side
• Patients who have active or suspected infection, local or systemic that, in the opinion of the investigator, may put patients at undue risk.
• Patient with pre-existing condition(s) that may interfere with the survival of the implant or their outcomes, including: Sickle Cell Anemia, Lower extremity muscular atrophy, Neuromuscular disease, Vascular insufficiency, Metabolic Disorders which impair bone formation, Paget's Disease, Charcot's Disease, Osteomalacia, Osteoporosis, Osteopenia.
• Patients with clinical conditions that may limit follow-up (in the opinion of the investigator) including: Immuno-compromised conditions (i.e. HIV), Hepatitis, Tuberculosis, Neoplastic disease such as cancer of the prostate, lung, stomach, cervix, etc.
• Chronic renal failure
• Organ transplant (i.e., heart, liver, lung, etc.) recipients
• Known disease process that in the opinion of the investigator may limit long term (4 year) follow up (i.e., multiple sclerosis, leukemia, lymphoma, etc.)
• Patients diagnosed with Parkinson's or Alzheimer's Disease
• Patients who have had an above-knee amputation in the contralateral leg Instability or deformity of the ligaments and/or surrounding soft tissue, which would preclude stability of the prostheses
• Patients with a known metal allergy
• Prisoners or, individuals who are known to be abusing drugs or alcohol or are mentally incompetent
• Patients who have received systemic steroids within the past 6 months or steroid injection into the affected knee within the previous 6 weeks prior to enrollment
• Patients taking immunosuppressives
• Patients who are pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study

Where it is running

• JIS Research Institute — New Albany, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.