We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Outcomes and Cost-effectiveness Analysis of ShapeMatch Technology

This study has been terminated.
(FDA recall - Canadian system did voluntary suspension of study; Investigators subsequently decided to terminate the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01483066
First Posted: December 1, 2011
Last Update Posted: October 31, 2017
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.
Collaborator:
Stryker Canada LP
Information provided by (Responsible Party):
Lauren Beaupre, University of Alberta
  Purpose

The currently held belief is that total knee replacement (TKR) requires the restoration of the overall limb alignment to coincide with the mechanical limb axis. To align the knee implants with this mechanical axis, rods are used to orient cutting guides with the mechanical axis as defined by the center of the femoral head and talus. Standard surgical technique typically involves femoral and tibial rods with cutting blocks to facilitate the intraoperative alignment of the initial femoral and tibia bone cuts. This approach is the method used for the traditional TriathlonÒ instrumentation. The Patient Specific Cutting Guides are designed to offer an alternative for alignment rods. ShapeMatch Technology places a plastic cutting guide on the end of the femur and tibia, so that cuts that do not automatically default to the mechanical axis, but rather attempt to recreate the patient's anatomic alignment. The surgeon can then assess implant placement and adjust as necessary during pre-operative planning. Thus, Patient Specific Cutting Guides give the surgeon better control over the placement of the implants.

This study will be a prospective, randomized evaluation of ShapeMatch Technology for primary TKR in a consecutive series of patients who meet the eligibility criteria. The clinical study will be accompanied by a formal cost-effectiveness analysis of one-year outcomes.

One half of the cases enrolled will receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides designed to reproduce the natural kinematic alignment of the knee. The other half of the cases will receive the Triathlon® CR device in a procedure using traditional instrumentation, without navigation, designed to produce a neutral mechanical alignment. Subjects will be evaluated using validated measures within 3 months prior to surgery and at 6 weeks, 3 months, and 1 and 2 years postoperatively.

Primary Hypothesis:

The investigators expect that ShapeMatch Technology will be as cost-effective as usual care.

Secondary Hypotheses:

The investigators expect that ShapeMatch Technology will result in improved clinical outcomes relative to usual care at three months postoperatively.

The investigators expect that ShapeMatch Technology will result in similar clinical outcomes relative to usual care at two-years postoperatively.


Condition Intervention Phase
Total Knee Arthroplasty Device: ShapeMatch Technology Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Prospective, Randomized, Post-market, Multi-center Study and Cost-effectiveness Analysis of ShapeMatch Technology A Prospective, Randomized, Post-market, Multi-center Study and Cost-effectiveness Analysis of ShapeMatch Technology

Further study details as provided by Lauren Beaupre, University of Alberta:

Primary Outcome Measures:
  • Cost-effectiveness analysis (CEA) [ Time Frame: surgery to one year postoperatively ]

    The CEA will examine the cost of health care resources and health outcomes from the surgical intervention to 1-year postoperatively. The costs will include all health care utilization during this time. Health care utilization, and associated costs, related to the patients' condition, the surgery and adverse events of the surgery will be the basis of a sensitivity analysis.

    Quality adjusted life years (QALYs) is the preferred measure for CEA. QALYs will be calculated based on the EuroQol-5D (EQ-5D). An objective outcome measure may be used for additional analysis.



Secondary Outcome Measures:
  • Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: preoperative - 2 years postoperative ]
    The KOOS is an instrument used to assess the patient's opinion about his or her knee and associated problems and has been validated for use in this population.

  • EuroQol-5D (EQ-5D) [ Time Frame: preoperative to 2-years postoperative ]
    The EQ-5D is a generic health status questionnaire that will be used to measure overall health status and will be used in the CEA.

  • University of California at Los Angeles (UCLA) Activity Scale [ Time Frame: preoperative to 2-years postoperative ]
    The UCLA activity score is a self-administered patient evaluation designed to reflect patient activity.

  • Forgotten Joint Score [ Time Frame: Imediate postoperative to 2 years postoperative ]
    The Forgotten Joint Score is a recently developed tool that examines how aware the subject is of their TKR during activities of daily living.


Enrollment: 38
Study Start Date: June 2012
Study Completion Date: June 26, 2015
Primary Completion Date: June 26, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ShapeMatch Instrumentation Device: ShapeMatch Technology
ShapeMatch Technology places a plastic cutting guide on the end of the femur and tibia, so that cuts that do not automatically default to the mechanical axis, but rather attempt to recreate the patient's anatomic alignment.
Active Comparator: Usual Instrumentation Device: ShapeMatch Technology
ShapeMatch Technology places a plastic cutting guide on the end of the femur and tibia, so that cuts that do not automatically default to the mechanical axis, but rather attempt to recreate the patient's anatomic alignment.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is a male or non-pregnant female age 18 to 80 years of age at the time of study device implantation.
  • Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
  • Patient is a candidate for a primary total knee replacement (TKR).
  • Patient is willing and able to comply with preoperative Magnetic Resonance Imaging (MRI) requirements, postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

  • Patient has a Body Mass Index (BMI) ≥ 40.
  • Patient has a varus or valgus deformity greater than 10 degrees or flexion contracture greater than 20o.
  • Patient has an active or suspected latent infection in or about the affected joint at time of study device implantation.
  • Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year.
  • Patient requires bilateral TKR, or has had a contralateral partial TKR or TKR.
  • Patient has any implanted device that would be incompatible with MRI procedures.
  • Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
  • Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
  • Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements(e.g. > 30 days).
  • Patient requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint.
  • Patient has a known sensitivity to device materials.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01483066


Locations
Canada, Alberta
Alberta Health Services - Edmonton zone
Edmonton, Alberta, Canada, TG6 2B7
Sponsors and Collaborators
Lauren Beaupre
Stryker Canada LP
Investigators
Principal Investigator: Gordon Arnett, MD, FRCS (C) Alberta Health Services
Study Director: Lauren Beaupre, PT, PhD University of Alberta
  More Information

Responsible Party: Lauren Beaupre, PT, PhD, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01483066     History of Changes
Other Study ID Numbers: Pro00024283
First Submitted: November 25, 2011
First Posted: December 1, 2011
Last Update Posted: October 31, 2017
Last Verified: October 2017