Prospective Randomized Study of Cementless vs Cemented UKA

NCT05377450 | Active Not Recruiting FDA Device

• 1 other identifier: 2022-Engage PKA
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• KOOS JR Score

  KOOS JR is a survey evaluating knee health for individuals following joint replacement by evaluating stiffness, pain, function, and activities of daily living.

  2 Years

Secondary Outcomes (4)

• Pain Score

  6 weeks; 3, 6, 9, 12 and 24 months

• Range of Motion

  6 weeks; 3, 6, 9, 12 and 24 months

• KOOS JR Score

  6 weeks; 3, 6, 9, and 12 months

• Implant Survivorship

  2 Year

Study Arms (2)

Cemented Engage Partial Knee

ACTIVE COMPARATOR

Engage partial knee implanted with bone cement for fixation.

Device: Engage Partial Knee

Cementless Engage Partial Knee

ACTIVE COMPARATOR

Engage partial knee implanted with cementless fixation.

Device: Engage Partial Knee

Interventions

Engage Partial Knee DEVICE

Unicompartmental knee arthroplasty utilizing the Engage Partial Knee system with bone cement.

Cemented Engage Partial Knee

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• JIS Research Institute: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

JIS Research Institute

New Albany, Ohio, 43054, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• David A Crawford, MD

  JIS Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 17, 2022
• Study Start: August 29, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)