Prospective Randomized Study of Cementless vs Cemented UKA

JIS Research Institute

Status

Active, not recruiting

Conditions

Osteoarthritis, Knee

Treatments

Device: Engage Partial Knee

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05377450

2022-Engage PKA

Details and patient eligibility

About

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

Full 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.

Enrollment

108 estimated patients

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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 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
Patients with severe valgus or varus knees (valgus or varus angulation of more than 20°) where collateral ligament, iliotibial band, or popliteal release is required
Patients who refuse to sign the IRB approved Informed Consent Form
Participation in an interventional clinical research study procedure, other than a bilateral knee arthroplasty in this study, within the past 12 months
Patients with a history of osteomyelitis or sepsis of the index knee
Patients who require patellar resurfacing
Patients who are not skeletally mature
Patients who have had a total hip replacement procedure <18 months prior to entering the study
Patients who have had a contralateral non-study knee replacement procedure <18 months prior to entering the study
Patients who are found intraoperatively to have inadequate bone stock or other conditions that contraindicate a partial knee replacement
Patients who have a higher risk of falling
Patients who are smokers or a history of smoking in the past 12 months
Patients with alcoholism or drug addiction
Tumors of the supporting bone structures
Patients who have a permanent valgus or varus deformity including tibia vara deformity
Patients with BMI ≥ 40
Patients 80 years of age or older
Patients who have undergone same-day or staged bi-lateral partial knee replacement
Patients who may have an allergic reaction to the device materials or bone cement