Prospective Randomized Study of Cementless Versus Cemented Unicompartmental Knee Arthroplasty (UKA)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- JIS Research Institute
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- KOOS JR Score
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
To evaluate the non-inferiority of the cementless Engage Partial Knee System compared to cemented Engage Partial knee System.
Detailed Description
Medial unicompartmental knee arthroplasty has demonstrated outstanding success in the treatment of anteromedial osteoarthritis of the knee. Most UKA implants in the US market require cemented fixation, and there can be specific complications related to cement such as aseptic loosening between the bone-cement and/or cement-implant interface along with loose cement causing third-body wear of the remaining normal articular cartilage. Cementless devices offer a durable long-term fixation method with no risk of loose cement causing secondary damage.
Investigators
Eligibility Criteria
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
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 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°
Outcomes
Primary Outcomes
KOOS JR Score
Time Frame: 2 Years
KOOS JR is a survey evaluating knee health for individuals following joint replacement by evaluating stiffness, pain, function, and activities of daily living.
Secondary Outcomes
- KOOS JR Score(6 weeks; 3, 6, 9, and 12 months)
- Pain Score(6 weeks; 3, 6, 9, 12 and 24 months)
- Range of Motion(6 weeks; 3, 6, 9, 12 and 24 months)
- Implant Survivorship(2 Year)