Application of Radiostereometric Analysis (RSA) to Triathlon Knee Components Inserted Using the OtisMed Custom-fit Total Knee Replacement System

NCT01262430 | Completed

• 1 other identifier: CDHA-RS/2011-296
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The OtisMed Custom-fit system for total knee replacements replaces conventional surgical techniques for templating and intra-operative instrumentation with a preoperative virtual surgery process that utilizes 3D models of the affected knee from a pre-operative MRI or CT image. The 3D model of the affected knee is processed with a proprietary algorithm that virtually alters it to its pre-arthritic state by filling articular defects, removing osteophytes, and approximating the joint surface. The software then shape matches the knee replacement femoral and tibial components to the preathritic knee model and aligns the femoral component to the functional flexion-extension axis of the femur. The final preoperative step is the machining of custom biocompatible plastic cutting blocks that fit the arthritic knee. These cutting blocks are used during the knee replacement surgery to guide the bone cuts so that the replacement components are aligned for the individual patient. In this study we propose to compare patients who have received total knee replacement components with the OtisMed Custom-fit procedure to those who have had the same components implanted in the conventional manner with Computer Assisted Surgery (CAS). The primary outcome will be micromotion of tibial and femoral implants at 1 and 2 years after surgery. Secondary outcomes will include subjective outcomes, accelerometric gait analysis, bone mineral density, full leg alignment, change in intra-operative frontal plane alignment, intra-operative deviations from the surgical plan, surgery duration, OR turnover time, number of instrument pans used, and length of hospital stay.

Conditions

Osteoarthritis

Keywords

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• RSA migration

  2 years

Secondary Outcomes (4)

• RSA inducible displacement

  1 year

• Questionnaires

  2 years

• DEXA

  2 years

• Gait Analysis (accelerometric)

  2 years

Study Arms (2)

OtisMed

ACTIVE COMPARATOR

Procedure: OtisMed

Computer Assisted Surgery (CAS)

ACTIVE COMPARATOR

Procedure: Computer Assisted Surgery (CAS)

Interventions

OtisMed PROCEDURE

OtisMed Custom-fit Shapematching Guides

Also known as: Styrker OtisMed Custom-fit Shapematching Guides

OtisMed

Computer Assisted Surgery (CAS) PROCEDURE

Stryker Navigation System

Also known as: Stryker precisioN Knee Navigation System

Computer Assisted Surgery (CAS)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic osteoarthritis of the knee indicating surgical intervention
• Between the ages of 21 and 80 inclusive
• Ability to give informed consent

You may not qualify if:

• Significant co-morbidity affecting ability to ambulate
• Flexion contracture greater than 15°
• Extension lag greater than 10°
• Tibial subluxation greater than 10 mm on standing AP radiograph
• Prior arthroplasty, patellectomy or osteotomy with the affected knee
• Lateral or medial collateral ligament instability (\> 10° varus/valgus)
• Leg length discrepancy greater than 10 mm
• Pregnancy
• Active or prior infection
• Morbid Obesity (BMI \> 40)
• Medical condition precluding major surgery
• Severe osteoporosis or osteopenia
• Neuromuscular impairment

Sponsors & Collaborators

• Dalhousie University: lead

Study Sites (1)

Capital District Health Authority

Halifax, Nova Scotia, B3H 4A7, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Surgery, Computer-Assisted

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Michael Dunbar

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCSC, PhD

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 17, 2010
• Study Start: April 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2019
• Last Updated: August 21, 2020

Record last verified: 2020-08

Locations

CA (1)