Clinical trial NCT01763684: Oxford Signature vs. Conventional Global Study
Official title: A Global Comparison of Signature Guides and Conventional Instrumentation in the Oxford Partial Knee
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Osteoarthritis, Knee
Osteonecrosis
Keywords: Osteoarthritis
Osteoarthritis, Knee
Osteonecrosis
Arthritis
Knee Arthritis
Knee Replacement
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2013-01-09
Enrollment: 266
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Knees Achieving Optimal Alignment
timeFrame: 12 weeks
Secondary outcomes:
measure: Instruments Used During Surgery
timeFrame: Operative
measure: Knee Society Functional Score
timeFrame: 1 Year
measure: Leg Alignment Femoral Varus/Valgus
timeFrame: Directly Postoperative
measure: Blood Loss
timeFrame: Right after surgery (up to 2 hours after surgery)
measure: Knee Society Objective Score
timeFrame: 1 Year
measure: Oxford Knee Score
timeFrame: 1 Year
measure: EQ5D Score
timeFrame: 1 Year
measure: Leg Alignment Femoral Flexion/Extension
timeFrame: Directly Postoperative
measure: Leg Alignment Tibial Varus/Valgus
timeFrame: Directly Postoperative
measure: Leg Alignment Tibial Flexion/Extension
timeFrame: Directly Postoperative
Other outcomes:
Locations:
city: Elkhart
country: United States
facility: Orthopedic and Sports Medicine Center
state: Indiana
city: Rockville
country: United States
facility: The Orthopaedic Center
state: Maryland
city: Columbia
country: United States
facility: University of Missouri-Columbia Hospital and Clinics
state: Missouri
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Joint Implant Surgeons
state: Ohio
city: Austin
country: United States
facility: Texas Institute for Hip & Knee Surgery
state: Texas
city: Richmond
country: United States
facility: Advanced Orthopedics
state: Virginia
Study officials:
affiliation: Zimmer Biomet
name: Russell Schenck, Ph.D.
role: STUDY_DIRECTOR
References: