N/A
N=320
Safety and Efficacy of the Oxford Cementless Partial Knee System
Osteoarthritis, Knee · Avascular Necrosis of the Medial Femoral Condyle
Bottom Line
View on ClinicalTrials.gov: NCT01473134 ↗Enrolled (actual)
320
Serious AEs
8.4%
Results posted
Sep 2024
Primary outcome: Primary: Radiographic Success — 198; 112; 13; 3 knees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Oxford Cementless Partial Knee (Device); Oxford Cemented Partial Knee (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiographic Success |
198; 112; 13; 3 | — |
| PRIMARY Absence of Revision/Removal/Unanticipated Adverse Device Effect (UADE) |
203; 119; 13; 3 | — |
| PRIMARY The Knee Society Assessment Score |
95.6; 95.5 | — |
| PRIMARY The Knee Society Function Score |
89.4; 89.7 | — |
| SECONDARY Knee Society Assessment Score |
43.2; 45; 86.5; 87; 93.5; 94.2 | — |
| SECONDARY Knee Society Score Assessment for Bilateral Subjects |
43.4; 46.0; 86.6; 87.7; 93.7; 95.6 | — |
| SECONDARY Knee Society Function Score at All Timepoints |
58.1; 57.7; 65.4; 70.2; 86; 87.4 | — |
| SECONDARY Knee Society Function Score for Bilateral Subjects |
60.1; 56.3; 65.8; 72; 84.5; 88.8 | — |
| SECONDARY Oxford Knee Score |
23.7; 24.9; 32.4; 34.5; 41.8; 42.4 | — |
| SECONDARY Number of Knees Which Met the Criteria for Radiographic Success |
235; 129; 208; 115; 208; 113 | — |
| SECONDARY Patient Assessment of Satisfaction |
151; 95; 60; 27; 23; 9 | — |
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 the patients diagnosed with osteoarthritis or avascular necrosis gain mobility and decrease pain. All of the risks common to a conventional joint replacement are possible with this device as certain risks are associated with any invasive procedures. The study is designed to document and compare the clinical and radiographic results of the Oxford® Cementless Partial Knee System to those of the cemented Oxford® Partial Knee System (control treatment).
Eligibility Criteria
Inclusion Criteria
- Patients with a preoperative Knee Society Assessment Score of 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
Data sourced from ClinicalTrials.gov (NCT01473134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.