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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01262430
Recruitment Status : Active, not recruiting
First Posted : December 17, 2010
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
Michael Dunbar, Dalhousie University

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: OtisMed Procedure: Computer Assisted Surgery (CAS) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2011
Actual Primary Completion Date : August 2015
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. RSA migration [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. RSA inducible displacement [ Time Frame: 1 year ]
  2. Questionnaires [ Time Frame: 2 years ]
  3. DEXA [ Time Frame: 2 years ]
  4. Gait Analysis (accelerometric) [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01262430

Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 4A7
Sponsors and Collaborators
Dalhousie University
Principal Investigator: Michael Dunbar Dalhousie University

Responsible Party: Michael Dunbar, MD, FRCSC, PhD, Dalhousie University Identifier: NCT01262430     History of Changes
Other Study ID Numbers: CDHA-RS/2011-296
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Keywords provided by Michael Dunbar, Dalhousie University:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases