Signature Versus Computer Assisted Surgery Study

NCT01256216 | Completed

• 1 other identifier: 121509
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Joint Disease

Keywords

Arthritis; Osteoarthritis; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Mechanical Alignment

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

  Data Collected at 0-10 Weeks; but Analyzed at Completion of Study

Secondary Outcomes (1)

• Knee Society Objective Score

  Completion of Study

Study Arms (2)

Signature Custom Cutting Guides

OTHER

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

Device: Total Knee Replacement with Vanguard Total Knee

CAS (Computer Assisted Surgery)

OTHER

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

Device: Total Knee Replacement with Vanguard Total Knee

Interventions

Total Knee Replacement with Vanguard Total Knee DEVICE

Patients indicated for a total knee replacement utilizing the Vanguard Total Knee System.

CAS (Computer Assisted Surgery); Signature Custom Cutting Guides

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Russells Hall Hospital

Dudley, United Kingdom

Location

MeSH Terms

Conditions

Joint Diseases; Arthritis; Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Russell A Schenck, PhD

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2010
• First Posted: December 8, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 19, 2017

Record last verified: 2017-06

Locations

GB (1)