Signature Versus Computer Assisted Surgery Study

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01256216
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 68
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Joint Disease	Device: Total Knee Replacement with Vanguard Total Knee	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparison of Signature Custom Cutting Guides and Computer Assisted Surgery Techniques With the Vanguard Knee System
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Signature Custom Cutting Guides Patients receiving a Vanguard Total Knee implanted utilizing non implantable Signature Cutting Guides Surgical Technique.	Device: Total Knee Replacement with Vanguard Total Knee; Patients indicated for a total knee replacement utilizing the Vanguard Total Knee System.
Other: CAS (Computer Assisted Surgery) Patients receiving a Vanguard Total Knee implanted utilizing non implantable Computer Assisted Surgery Technique.	Device: Total Knee Replacement with Vanguard Total Knee; Patients indicated for a total knee replacement utilizing the Vanguard Total Knee System.

Outcome Measures

Primary Outcome Measures

1. Mechanical Alignment [Data Collected at 0-10 Weeks; but Analyzed at Completion of Study]

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

Secondary Outcome Measures

1. Knee Society Objective Score [Completion of Study]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Russells Hall Hospital	Dudley		United Kingdom

Sponsors and Collaborators

• Zimmer Biomet

Investigators

• Study Director: Russell A Schenck, PhD, Zimmer Biomet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT01256216
• Other Study ID Numbers: 121509
• First Posted: Dec 8, 2010
• Last Update Posted: Jun 19, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by Zimmer Biomet: Arthritis; Osteoarthritis; Arthroplasty
• Additional relevant MeSH terms: Joint Diseases

Study Results

No Results Posted as of Jun 19, 2017