Oxford Signature vs. Conventional Global Study

Osteoarthritis Clinical Trial

Official title:

A Global Comparison of Signature Guides and Conventional Instrumentation in the Oxford Partial Knee

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01763684
• Other study ID #: ORTHO.CR.GK7
• Status: Terminated
• Phase: N/A
• Start date: September 2012
• Est. completion date: August 2016

Study information

• Verified date: March 2021
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Osteonecrosis

Intervention

Device:
• Signature Custom Guides
Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).

Procedure:
• Conventional Instrumentation
Traditional partial knee arthroplasty without the use of Signature technology.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

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