Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using Shapematch Cutting Guides:Sub-Study A

NCT02516163 | Completed Results

• 1 other identifier: TriShapeMatch-10_Substudy A
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Arthroplasties, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Repeatability of Cutting Guide Position

  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.

Study Arms (1)

Shapematch Cutting Guides

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

Interventions

Shapematch Cutting Guides DEVICE

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

Shapematch Cutting Guides

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: Holly Solomon
• Organization: Stryker SP

Holly.Solomon@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 5, 2015
• Study Start: December 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 12, 2016
• Results First Posted: January 12, 2016

Record last verified: 2015-09