Overview

This trial is active, not recruiting.

Condition arthroplasties, replacement, knee
Treatment shapematch cutting guides with triathlon
Sponsor Stryker South Pacific
Start date June 2011
End date November 2012
Trial size 96 participants
Trial identifier NCT02527161, TriShapeMatch-10_SubStudyB

Summary

This is a prospective, non-randomized, longitudinal study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides. Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at each follow-up interval. This sub-study involved the assessment of the placement of the ShapeMatch® Cutting Guides intraoperatively and post-operatively. An assessment of post-operative patient outcomes compared to pre-operative status was also analysed.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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.
shapematch cutting guides with triathlon
All participants will undergo medical imaging assessment using Magnetic Resonance Imaging (MRI) of the affected lower limb.These images will be used to manufacture the patient-specific cutting guides for preparation of the bones prior to implantation of the total knee replacement (Pre-operatively). Patients will undergo primary total knee arthroplasty with the Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA) using the Shapematch cutting guides to guide the bone resection. Patients will follow the standard postoperative rehabilitation program established by the investigator at each site.

Primary Outcomes

Measure
Implant location
time frame: 3 months Post-Operatively
Knee function
time frame: 6 months post operatively

Secondary Outcomes

Measure
Forgotten Joint Score
time frame: 6 months Post-Operatively
Forgotten Joint Score
time frame: 12 months Post-Operatively
Forgotten Joint Score
time frame: 2 years Post-Operatively
Forgotten Joint Score
time frame: 5 years Post-Operatively
Mechanical Alignment
time frame: 12 months Post-Operatively
Revision rate
time frame: 5 years post-operatively
Knee Injury and Osteoarthritis Score (KOOS)
time frame: 6 months Post-Operatively
Knee Injury and Osteoarthritis Score (KOOS)
time frame: 12 months Post-Operatively
Knee Injury and Osteoarthritis Score (KOOS)
time frame: 2 years Post-Operatively
Knee Injury and Osteoarthritis Score (KOOS)
time frame: 5 years Post-Operatively
Short Form-12 item health survey v 2 (SF-12)
time frame: 6 months Post-Operatively
Short Form-12 item health survey v 2 (SF-12)
time frame: 12 months Post-Operatively
Short Form-12 item health survey v 2 (SF-12)
time frame: 2 years Post-Operatively
Short Form-12 item health survey v 2 (SF-12)
time frame: 5 years Post-Operatively
Pain
time frame: 6 months Post-Operatively
Pain
time frame: 12 months Post-Operatively
Pain
time frame: 2 years Post-Operatively
Pain
time frame: 5 years Post-Operatively

Eligibility Criteria

Male or female participants from 50 years up to 90 years old.

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).

Additional Information

Official title A Prospective, Non-randomized, Longitudinal 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 B
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Stryker South Pacific.