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Signature Versus Computer Assisted Surgery Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01256216
First received: May 12, 2010
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

The purpose of the data collection is to document the performance and clinical outcomes of the Vanguard Knee using Signature Custom Cutting Guides and Computer Assisted Surgery.


Condition Intervention
Joint Disease
Device: Signature Custom Cutting Guides
Other: Computer Assisted Surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Signature Custom Cutting Guides and Computer Assisted Surgery Techniques With the Vanguard Knee System

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Mechanical Alignment [ Time Frame: Data Collected at 0-10 Weeks; but Analyzed at Completion of Study ] [ Designated as safety issue: No ]
    Angle between femoral head, center of knee, and talus.


Secondary Outcome Measures:
  • Knee Society Objective Score [ Time Frame: Completion of Study ] [ Designated as safety issue: No ]
    Objective Scoring of Knee Society score is the clinical assessment which includes the sum of range of motion, stability, flexion contracture, extension lag, and alignment scores.


Estimated Enrollment: 306
Study Start Date: September 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Signature Custom Cutting Guides
TKA conducted with Signature (Signature Cutting Guides)
Device: Signature Custom Cutting Guides
Patients who received a Vanguard Knee using the Signature Guide operative technique.
CAS (Computer Assisted Surgery)
TKA conducted with CAS (Computer Assisted Surgery)
Other: Computer Assisted Surgery
Patients who received a Vanguard Knee using Computer Assisted Surgery operative technique.

Detailed Description:

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard® Knee System using Signature™ Custom Guides and Computer Assisted Surgery.

FDA has cleared the Vanguard Knee via premarket notification 510(k) K023546, K033489, and K050222. FDA has cleared the software for the Signature™ Custom Guides via premarket notification 510(k) K073449. The data gathered will be collated and used to provide feedback to design engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as a part of Biomet's Post Market Surveillance System.

Function will be assessed through the Knee Society Score. Survivorship will be documented by asking the surgeon to document revisions and complications.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria are identical to the indications for use stated in the FDA cleared labeling for the device (510(k) K023546, K033489, and K050222).

These indications are stated below:

  • Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
  • Correction of varus, valgus, or posttraumatic deformity.
  • Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
  • The Regenerex™ femoral augments are indicated for use with the Vanguard® Total Knee System.
  • The Regenerex™ tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.

Patient selection factors to be considered include:

  • Need to obtain pain relief and improve function
  • Ability and willingness of the patient to follow instructions, including control of weight and activity level
  • A good nutritional state of the patient, and
  • The patient must have reached full skeletal maturity
  • Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok™) devices and all polyethylene patellar components are indicated for cemented application only.

Exclusion Criteria: Exclusion criteria are identical to the contraindications stated in the FDA cleared labeling for the device 510(k) K023546, K033489, and K050222. These contraindications are stated below:

  • Absolute contraindications include: infection, sepsis, and osteomyelitis
  • Relative contraindications include:
  • Uncooperative patient or patient with neurologic disorders who is incapable of following directions
  • Osteoporosis
  • Metabolic disorders which may impair bone formation,
  • Osteomalacia
  • Distant foci of infections which may spread to the 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.
  • Biomet® Microplasty™ Tibial Trays are contraindicated for use with constrained bearings.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256216

Locations
United States, Texas
Medical Park Orthopaedic Clinic
Austin, Texas, United States, 78705
United Kingdom
Russells Hall Hospital
Dudley, United Kingdom
Sponsors and Collaborators
Biomet, Inc.
Investigators
Study Director: Russell A Schenck, PhD Biomet, Inc.
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01256216     History of Changes
Other Study ID Numbers: 121509
Study First Received: May 12, 2010
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Biomet, Inc.:
Arthritis
Osteoarthritis
Arthroplasty

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 20, 2014