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Signature Versus Computer Assisted Surgery Study

Primary Purpose

Joint Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Total Knee Replacement with Vanguard Total Knee
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Joint Disease focused on measuring Arthritis, Osteoarthritis, Arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Russells Hall Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Signature Custom Cutting Guides

CAS (Computer Assisted Surgery)

Arm Description

Patients receiving a Vanguard Total Knee implanted utilizing non implantable Signature Cutting Guides Surgical Technique.

Patients receiving a Vanguard Total Knee implanted utilizing non implantable Computer Assisted Surgery Technique.

Outcomes

Primary Outcome Measures

Mechanical Alignment
Angle between femoral head, center of knee, and talus.

Secondary Outcome Measures

Knee Society Objective Score
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.

Full Information

First Posted
May 12, 2010
Last Updated
June 16, 2017
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT01256216
Brief Title
Signature Versus Computer Assisted Surgery Study
Official Title
A Comparison of Signature Custom Cutting Guides and Computer Assisted Surgery Techniques With the Vanguard Knee System
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Disease
Keywords
Arthritis, Osteoarthritis, Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Signature Custom Cutting Guides
Arm Type
Other
Arm Description
Patients receiving a Vanguard Total Knee implanted utilizing non implantable Signature Cutting Guides Surgical Technique.
Arm Title
CAS (Computer Assisted Surgery)
Arm Type
Other
Arm Description
Patients receiving a Vanguard Total Knee implanted utilizing non implantable Computer Assisted Surgery Technique.
Intervention Type
Device
Intervention Name(s)
Total Knee Replacement with Vanguard Total Knee
Intervention Description
Patients indicated for a total knee replacement utilizing the Vanguard Total Knee System.
Primary Outcome Measure Information:
Title
Mechanical Alignment
Description
Angle between femoral head, center of knee, and talus.
Time Frame
Data Collected at 0-10 Weeks; but Analyzed at Completion of Study
Secondary Outcome Measure Information:
Title
Knee Society Objective Score
Description
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.
Time Frame
Completion of Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell A Schenck, PhD
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Russells Hall Hospital
City
Dudley
Country
United Kingdom

12. IPD Sharing Statement

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Signature Versus Computer Assisted Surgery Study

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