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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01763684
Other study ID # ORTHO.CR.GK7
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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