Oxford Signature vs. Conventional Global Study

Not Applicable

Terminated

Conditions: Osteoarthritis
Osteoarthritis, Knee
Osteonecrosis

Interventions: Procedure: Conventional Instrumentation
Device: Signature Custom Guides

Registration Number: NCT01763684

Lead Sponsor: Zimmer Biomet

Brief Summary: 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).

Detailed Description: The primary objectives of this global clinical study are to collect data to assess the following clinical evidence parameters that were gathered from Biomet team members and KOL globally for this product:

1. Evaluate the performance \& accuracy of the Oxford Partial Knee System with Signature Knee Guide in comparison to conventional instrumentation.

2. Compare the accuracy of Signature Guides between two user profiles: high volume surgeons \& low volume surgeons in a global mix.

3. Assess potential economic \& efficiency advantages in the short term and long-term: OR efficiency, patient quality of life and activity, clinical outcomes.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 266

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Instrumentation	Conventional Instrumentation	Oxford Partial Knee implanted using Conventional Instrumentation
Signature Custom Guides	Signature Custom Guides	Oxford Partial Knee implanted using Signature Custom Guides

Primary Outcome Measures

Name	Time	Method
Percentage of Knees Achieving Optimal Alignment	12 weeks	Percentage of Knees Achieving Optimal Alignment defined as a difference of 5 or less between all target and observed angles.

Secondary Outcome Measures

Name	Time	Method
Instruments Used During Surgery	Operative	Number of Instrument cases used to complete index surgery.
Knee Society Objective Score	1 Year	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
Leg Alignment Tibial Varus/Valgus	Directly Postoperative	Mechanical Leg Alignment of Components (degrees): Difference of Tibial Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle
Blood Loss	Right after surgery (up to 2 hours after surgery)	Blood Loss during surgery
Leg Alignment Femoral Varus/Valgus	Directly Postoperative	Mechanical Leg Alignment of Components (degrees): Difference of Femoral Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle
Knee Society Functional Score	1 Year	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
Oxford Knee Score	1 Year	Oxford Knee Score (OKS). Scored from 0 to 48 with 0 being the worst possible outcome and 48 being the best outcome
EQ5D Score	1 Year	EuroQol 5D Quality of Life score. Range from 0 to 1 with 1 being the best outcome.
Leg Alignment Femoral Flexion/Extension	Directly Postoperative	Mechanical Leg Alignment of Components (degrees): Difference of Femoral Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle
Leg Alignment Tibial Flexion/Extension	Directly Postoperative	Mechanical Leg Alignment of Components (degrees): Difference of Tibial Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle

Trial Locations

Locations (7): Joint Implant Surgeons
🇺🇸
Columbus, Ohio, United States
University of Missouri-Columbia Hospital and Clinics
🇺🇸
Columbia, Missouri, United States
The Orthopaedic Center
🇺🇸
Rockville, Maryland, United States
Orthopedic and Sports Medicine Center
🇺🇸
Elkhart, Indiana, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Texas Institute for Hip & Knee Surgery
🇺🇸
Austin, Texas, United States
Advanced Orthopedics
🇺🇸
Richmond, Virginia, United States