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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michael Dunbar, Dalhousie University
ClinicalTrials.gov Identifier:
NCT01262430
First received: December 10, 2010
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Osteoarthritis
Procedure: OtisMed
Procedure: Computer Assisted Surgery (CAS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial Using RSA to Compare the OtisMed Customfit Total Knee Replacement Procedure With Computer Assisted Surgery

Resource links provided by NLM:


Further study details as provided by Dalhousie University:

Primary Outcome Measures:
  • RSA migration [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • RSA inducible displacement [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Questionnaires [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • DEXA [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Gait Analysis (accelerometric) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: April 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: OtisMed Procedure: OtisMed
OtisMed Custom-fit Shapematching Guides
Other Name: Styrker OtisMed Custom-fit Shapematching Guides
Active Comparator: Computer Assisted Surgery (CAS) Procedure: Computer Assisted Surgery (CAS)
Stryker Navigation System
Other Name: Stryker precisioN Knee Navigation System

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Symptomatic osteoarthritis of the knee indicating surgical intervention
  2. Between the ages of 21 and 80 inclusive
  3. Ability to give informed consent

Exclusion Criteria:

  1. Significant co-morbidity affecting ability to ambulate
  2. Flexion contracture greater than 15°
  3. Extension lag greater than 10°
  4. Tibial subluxation greater than 10 mm on standing AP radiograph
  5. Prior arthroplasty, patellectomy or osteotomy with the affected knee
  6. Lateral or medial collateral ligament instability (> 10° varus/valgus)
  7. Leg length discrepancy greater than 10 mm
  8. Pregnancy
  9. Active or prior infection
  10. Morbid Obesity (BMI > 40)
  11. Medical condition precluding major surgery
  12. Severe osteoporosis or osteopenia
  13. Neuromuscular impairment
  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: NCT01262430

Locations
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, b3h3a7
Sponsors and Collaborators
Dalhousie University
Investigators
Principal Investigator: Michael Dunbar Dalhousie University
  More Information

No publications provided

Responsible Party: Michael Dunbar, MD, PhD, Dalhousie University
ClinicalTrials.gov Identifier: NCT01262430     History of Changes
Other Study ID Numbers: CDHA-RS/2011-296
Study First Received: December 10, 2010
Last Updated: March 28, 2014
Health Authority: Canada: Health Canada

Keywords provided by Dalhousie University:
Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014