Oxford Signature vs. Conventional Global Study
This study is currently recruiting participants.
Verified March 2013 by Biomet, Inc.
Sponsor:
Biomet, Inc.
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01763684
First received: November 6, 2012
Last updated: March 8, 2013
Last verified: March 2013
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Osteoarthritis Osteoarthritis, Knee Osteonecrosis |
Device: Signature Custom Guides Procedure: Conventional Instrumentation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Global Comparison of Signature Guides and Conventional Instrumentation in the Oxford Partial Knee |
Resource links provided by NLM:
Further study details as provided by Biomet, Inc.:
Primary Outcome Measures:
- Percentage of Knees Achieving Optimal Alignment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Average Number of Instrument Cases Used [ Time Frame: Right after surgery (up to 2 hours after surgery) ] [ Designated as safety issue: No ]
- Operative Time [ Time Frame: Immediate Post-Operative ] [ Designated as safety issue: No ]
- Patient Satisfaction [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
- Knee Function, Pain, and Range of Motion [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
- Radiographic Outcomes [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- Mechanical Leg Alignment of Components (degrees)
- Radiographic Failure due to either loosening or migration of components will be documented
- Tourniquet Time [ Time Frame: Right after surgery (up to 2 hours after surgery) ] [ Designated as safety issue: No ]
- Implant Sizing [ Time Frame: Right after surgery (up to 2 hours after surgery) ] [ Designated as safety issue: No ]
- Blood Loss [ Time Frame: Right after surgery (up to 2 hours after surgery) ] [ Designated as safety issue: No ]
- Transfusion Rate [ Time Frame: Right after surgery (up to 2 hours after surgery) ] [ Designated as safety issue: No ]
- Use of Cell-Saver [ Time Frame: Right after surgery (up to 2 hours after surgery) ] [ Designated as safety issue: No ]
- Number of Drains Used [ Time Frame: Right after surgery (up to 2 hours after surgery) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 440 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | June 2024 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Signature Custom Guides
Oxford Partial Knee implanted using Signature Custom Guides
|
Device: Signature Custom Guides |
|
Active Comparator: Conventional Instrumentation
Oxford Partial Knee implanted using Conventional Instrumentation
|
Procedure: Conventional Instrumentation |
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763684
Locations
| United States, Indiana | |
| Orthopedic and Sports Medicine Center | Recruiting |
| Elkhart, Indiana, United States, 46514 | |
| Contact: Kelly Ganz 574-264-0791 kganz@osmc.com | |
| Principal Investigator: Mark A Klaassen, MD | |
Sponsors and Collaborators
Biomet, Inc.
More Information
No publications provided
| Responsible Party: | Biomet, Inc. |
| ClinicalTrials.gov Identifier: | NCT01763684 History of Changes |
| Other Study ID Numbers: | ORTHO.CR.GK7 |
| Study First Received: | November 6, 2012 |
| Last Updated: | March 8, 2013 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Austria: Agency for Health and Food Safety Belgium: Federal Agency for Medicinal Products and Health Products Germany: Federal Institute for Drugs and Medical Devices Australia: Human Research Ethics Committee |
Keywords provided by Biomet, Inc.:
|
Osteoarthritis Osteoarthritis, Knee Osteonecrosis |
Arthritis Knee Arthritis Knee Replacement |
Additional relevant MeSH terms:
|
Osteoarthritis Osteonecrosis Osteoarthritis, Knee Arthritis Joint Diseases |
Musculoskeletal Diseases Rheumatic Diseases Bone Diseases Necrosis Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013