ShapeMatch Cutting Guide Functional Outcomes Study

Stryker

Status: Terminated

Conditions: Arthroplasty, Replacement, Knee

Treatments: Device: Triathlon® CR/Kinematic Alignment; Device: Triathlon® CR/Neutral Overall Limb Alignment; Device: Triathlon® CR/Conventional Limb Alignment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02539992

K-S-045

Details and patient eligibility

About

Randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement (TKR) in a consecutive series of patients who meet the eligibility criteria.

Full description

This study will be a prospective, randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement (TKR) in a consecutive series of patients who meet the eligibility criteria. Forty-eight cases enrolled will receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee. Another forty-eight cases enrolled will receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee. And the last forty-eight cases will receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment.

Enrollment: 44 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient has signed an ethic commission approved study specific Informed Patient Consent Form.
2. Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
3. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
4. Patient is a candidate for a primary total knee replacement.
5. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion criteria

1. Patient has a Body Mass Index (BMI) ≥ 40.
2. Patient age ≥ 80.
3. Patient has a varus or valgus deformity greater than 10 degree or flexion contracture greater than 20 degree.
4. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
5. 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.
6. Patient requires bilateral total knee replacements, or has a history of contralateral partial or total knee replacement.
7. Patient has any implanted device that would be incompatible with MRI procedures.
8. Patient has chronic heart failure (NYHA Stage ≥ 2)
9. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
10. 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.
11. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
12. Patient requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint.
13. Patient has a known sensitivity to device materials.
14. Patient is a prisoner.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 3 patient groups

Triathlon® CR/Kinematic Alignment

Active Comparator group

Description:

Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.

Treatment:

Device: Triathlon® CR/Kinematic Alignment

Triathlon® CR/Neutral Overall Limb Alignment

Active Comparator group

Description:

Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.

Treatment:

Device: Triathlon® CR/Neutral Overall Limb Alignment

Triathlon® CR/Conventional Limb Alignment

Active Comparator group

Description:

Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.

Treatment:

Device: Triathlon® CR/Conventional Limb Alignment