Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B

NCT02527161 | Completed Results

• 1 other identifier: TriShapeMatch-10_SubStudyB
• Study Type: interventional
• Target: 205
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Arthroplasties, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Implant Location/Assessment of Alignment

  Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees.

  3 months Post-Operatively

Secondary Outcomes (13)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain

  Pre-operative to 5 years post-operative

• Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms

  Pre-operative to 5 years post-operative

• Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL

  Pre-operative to 5 years post-operative

• Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R

  Pre-operative to 5 years Post-Operative

• Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL

  Pre-operative to 5 years post-operative

Study Arms (1)

ShapeMatch Cutting Guides with Triathlon

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.

Device: ShapeMatch Cutting Guides with Triathlon

Interventions

ShapeMatch Cutting Guides with Triathlon DEVICE

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.

ShapeMatch Cutting Guides with Triathlon

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stryker South Pacific: lead

Results Point of Contact

• Title: David Fulker
• Organization: Stryker SP

david.fulker@stryker.com

+61 2 9467 1072

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 18, 2015
• Study Start: June 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: April 1, 2018
• Last Updated: September 18, 2020
• Results First Posted: October 28, 2015

Record last verified: 2020-09