Status:
COMPLETED
Safety and Efficacy of the Oxford Cementless Partial Knee System
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis, Knee
Avascular Necrosis of the Medial Femoral Condyle
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The objective of this clinical investigation is to evaluate the safety and effectiveness of the Oxford® Cementless Partial Knee System. The Oxford® Cementless Partial Knee System is intended to help t...
Detailed Description
Prospectively controlled, randomized Investigational study. Patients are asked to come in pre-operatively, surgery, 6 weeks, 6 months, 1 year, 2 years and annually until the last patient reaches their...
Eligibility Criteria
Inclusion
- Patients with a preoperative 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 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 Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL)
- Patients who needs to obtain relief of pain and/or improved function in their knee
- Patients with fixed flexion deformity \<15 degrees
- Patients who are able to follow postoperative care instructions
- Patients who are willing and able to return for scheduled follow-up evaluations
- Patients in which natural alignment can be restored
- Patients who have completed a valid, Institutional Review Board (IRB) approved Informed Consent Form
- Patients with child-bearing potential who voluntarily agree to prevent pregnancy for 2 years following device implantation
Exclusion
- Patients with a preoperative Knee Society Assessment Score of greater than or equal to 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 degrees
- Patients with a fixed varus deformity \> 15 degrees
- Patients who have rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Patients with a fused knee on operative side(s)
- Patients who have active or suspected infection, local or systemic that, in the opinion of the investigator, may put patients at undue risk
- Patients with pre-existing condition(s) that may interfere with the survival of the implants 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
- Severe Osteoporosis
- Patients with clinical conditions that may limit follow-up (in the opinion of the investigator) including:
- Immunocompromised 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 injections into the affected knee within the previous 6 weeks prior to enrollment
- Patients who are pregnant
- Patients with severe valgus or varus knees (valgus or varus angulation of more than 20 degrees) 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT01473134
Start Date
December 1 2011
End Date
November 30 2021
Last Update
August 11 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Orthopedic & Sports Medicine Center of Northern Indiana, Inc.
Elkhart, Indiana, United States, 46514
2
Midwest Center for Hip and Knee Surgery
Indianapolis, Indiana, United States, 46241
3
Miller Orthopaedic Affiliates
Council Bluffs, Iowa, United States, 51503
4
Twin City Orthopedics
Edina, Minnesota, United States, 55435