- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02516163
Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using Shapematch Cutting Guides:Sub-Study A
December 7, 2015 updated by: Stryker South Pacific
A Prospective, Non-randomized,Study of the Clinical Outcomes of Participants That Receive the Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study A
This is a prospective, non-randomized, study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, non-randomized, study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides.
Sub-study A aims to quantify the reproducibility of intra-operatively positioning the cutting guides onto the affected femoral and tibial joint surfaces.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The patient is a male or non-pregnant female between the ages of 50-90.
- The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
- The patient has a primary diagnosis of osteoarthritis (OA).
- The patient has intact collateral ligaments.
- The patient is able to undergo MRI scanning of the affected limb.
- The patient has signed the study specific, HREC-approved, Informed Consent document.
- The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
Exclusion Criteria:
- The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
- The patient has had a high tibial osteotomy or femoral osteotomy.
- The patient is morbidly obese (BMI ≥ 40).
- The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
- The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical axis).
- The patient has a fixed flexion deformity ≥ 15°.
- The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
- The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
- The patient has a cognitive impairment, an intellectual disability or a mental illness.
- The patient is pregnant.
- The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).
- The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Shapematch Cutting Guides
The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting. They are intended for single use only. |
Participants will undergo pre-operative assessment using MRI of the affected limb.
At the time of surgery, a repeated-measures methodology will be implemented in which the position of the femoral and tibial cutting guides will be measured using the Navigation system.
The same surgeon will position each cutting guide a total of 3 times for each patient.
Multiple participants will be assessed by each surgeon.
No bone cuts will take place using the patient-specific cutting guides.
After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system and associated instruments.
No post-operative evaluations will be undertaken as part of this sub-study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Repeatability of Cutting Guide Position
Time Frame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
|
Repeatability of cutting guide position on the distal femur and proximal tibia assessed by repeated measures using computer navigation system for total knee replacement, assessed intra-operatively.
Placement of the cutting guides by the surgeon was determined by recording the position of the cutting guide when placed by the same surgeon multiple times.
The intraclass correlation coefficient (ICC) was calculated for each positioning parameter.
This included femoral and tibial varus/valgus,flexion/extension, medial resection, lateral resection and rotation.
ICC agreement categories:>0.75 excellent agreement; 0.75-0.4
good or fair agreement; <0.4 poor agreement.
|
Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
August 3, 2015
First Submitted That Met QC Criteria
August 3, 2015
First Posted (Estimate)
August 5, 2015
Study Record Updates
Last Update Posted (Estimate)
January 12, 2016
Last Update Submitted That Met QC Criteria
December 7, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- TriShapeMatch-10_Substudy A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthroplasties, Replacement, Knee
-
Molnlycke Health Care ABCompletedArthroplasties, Hip Replacement | Arthroplasties, Knee ReplacementUnited States
-
Stryker South PacificCompletedKnee Replacement | Arthroplasties
-
University of Colorado, DenverNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Recruiting
-
CorinActive, not recruitingArthroplasties, Knee ReplacementUnited States
-
Washington University School of MedicineStryker NordicCompletedArthroplasties, Knee ReplacementUnited States
-
Stryker South PacificCompletedArthroplasties, Replacement, Knee
-
Hospital District of Helsinki and UusimaaUniversity of Turku; Karlstad UniversityCompletedArthroplasties, Hip Replacement | Arthroplasties, Knee ReplacementFinland
-
University of AarhusEnrolling by invitationArthroplasties, Hip ReplacementDenmark
-
Smith & Nephew, Inc.TerminatedArthroplasties, Hip ReplacementUnited States, Belgium, Canada
-
University of Wisconsin, MadisonRadius Health, Inc.Active, not recruitingOsteoporosis | Arthroplasties, Knee ReplacementUnited States
Clinical Trials on Shapematch Cutting Guides
-
Stryker South PacificCompletedArthroplasties, Replacement, Knee
-
Thammasat UniversityCompletedKnee OsteoarthritisThailand
-
Medacta USAWithdrawnKnee Osteoarthritis | Knee Pain Chronic
-
University of AlbertaStryker Canada LPTerminatedTotal Knee ArthroplastyCanada
-
University of Lausanne HospitalsActive, not recruiting
-
Zimmer BiometTerminatedOsteoarthritis | Osteoarthritis, Knee | OsteonecrosisUnited States
-
Johnson & Johnson Vision Care, Inc.Completed
-
SLS FranceGlobal DRecruitingSurgery | Maxilla FractureBelgium, France
-
Johnson & Johnson Vision Care, Inc.Completed