Osteoarthritis Clinical Trial
Official title:
A Global Comparison of Signature Guides and Conventional Instrumentation in the Oxford Partial Knee
Verified date | March 2021 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will compare alignment criteria in the Oxford Partial Knee using conventional instrumentation and Signature Custom Guides in order to determine if the use of the Signature Custom Guides results in a higher percentage of knees achieving optimal alignment. The study will also examine outcomes with high volume surgeons (>30 cases/year) and low volume surgeons (<10 cases/year).
Status | Terminated |
Enrollment | 266 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Intended for use in individuals with osteoarthritis or Avascular necrosis limited to the medial compartment of the knee that is also lacking patellofemoral or lateral compartment disease. - Use of cementless femoral fixation is permitted outside of the United States if it complies with all local, state, and/or national and international regulations. The same technique must be used consistently throughout the course of the study with all cases - Patients 21 and over Exclusion Criteria: - Use of Cementless Fixation in the United States - Infection, sepsis or osteomyelitis - Use in lateral compartment of the knee - Rheumatoid arthritis or other forms of inflammatory joint disease - Revision of failed prosthesis, failed upper tibial osteotomy, or post traumatic arthritis after tibial plateau fracture - Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device. - Disease or damage to the lateral compartment of the knee - Uncooperative patient or patient with neurologic disorders who is incapable of following directions - Osteoporosis in the United States / Insufficient bone stock outside the United States - Metabolic disorders which may impair bone formation - Osteomalacia - Distant foci of infections which may spread to implant site - Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram - Vascular insufficiency, muscular atrophy, neuromuscular disease. - Incomplete or deficient soft tissue surrounding the knee. - Charcot's disease - A fixed varus deformity (not passively correctable) of greater than 15 degrees - A flexion deformity greater than 15 degrees. - Non-staged Bilateral patients - Patients who refuse, cannot, or should not receive a CT or MRI. Since patients are randomized into treatment groups, all patients must be able to receive an MRI (should follow local MRI screening protocol). This excludes patients who have metal artifacts in the knee, patients who are too large to fit into the knee coil, patients with pacemakers, patients unable to lie still for the duration of the MRI, and patients who are claustrophobic. |
Country | Name | City | State |
---|---|---|---|
United States | Texas Institute for Hip & Knee Surgery | Austin | Texas |
United States | University of Missouri-Columbia Hospital and Clinics | Columbia | Missouri |
United States | Joint Implant Surgeons | Columbus | Ohio |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Orthopedic and Sports Medicine Center | Elkhart | Indiana |
United States | Advanced Orthopedics | Richmond | Virginia |
United States | The Orthopaedic Center | Rockville | Maryland |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Knees Achieving Optimal Alignment | Percentage of Knees Achieving Optimal Alignment defined as a difference of 5 or less between all target and observed angles. | 12 weeks | |
Secondary | Instruments Used During Surgery | Number of Instrument cases used to complete index surgery. | Operative | |
Secondary | Knee Society Functional Score | Functional Score from Knee Society Score. These are 3 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions | 1 Year | |
Secondary | Leg Alignment Femoral Varus/Valgus | Mechanical Leg Alignment of Components (degrees): Difference of Femoral Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle | Directly Postoperative | |
Secondary | Blood Loss | Blood Loss during surgery | Right after surgery (up to 2 hours after surgery) | |
Secondary | Knee Society Objective Score | Objective score from Knee Society Score. These are 7 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions | 1 Year | |
Secondary | Oxford Knee Score | Oxford Knee Score (OKS). Scored from 0 to 48 with 0 being the worst possible outcome and 48 being the best outcome | 1 Year | |
Secondary | EQ5D Score | EuroQol 5D Quality of Life score. Range from 0 to 1 with 1 being the best outcome. | 1 Year | |
Secondary | Leg Alignment Femoral Flexion/Extension | Mechanical Leg Alignment of Components (degrees): Difference of Femoral Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle | Directly Postoperative | |
Secondary | Leg Alignment Tibial Varus/Valgus | Mechanical Leg Alignment of Components (degrees): Difference of Tibial Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle | Directly Postoperative | |
Secondary | Leg Alignment Tibial Flexion/Extension | Mechanical Leg Alignment of Components (degrees): Difference of Tibial Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle | Directly Postoperative |
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