ShapeMatch Cutting Guide Functional Outcomes Study

NCT ID: NCT02539992

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-05-31

Brief Summary

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

Detailed 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.

Conditions

Arthroplasty, Replacement, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triathlon® CR/Kinematic Alignment

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.

Group Type: ACTIVE_COMPARATOR

Triathlon® CR/Kinematic Alignment

Intervention Type: DEVICE

Total knee replacement using patient-specific cutting guides

Triathlon® CR/Neutral Overall Limb Alignment

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

Group Type: ACTIVE_COMPARATOR

Triathlon® CR/Neutral Overall Limb Alignment

Intervention Type: DEVICE

Total knee replacement using patient-specific cutting guides

Triathlon® CR/Conventional Limb Alignment

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

Group Type: ACTIVE_COMPARATOR

Triathlon® CR/Conventional Limb Alignment

Intervention Type: DEVICE

Total knee replacement using traditional instrumentation

Interventions

Triathlon® CR/Kinematic Alignment

Total knee replacement using patient-specific cutting guides

Intervention Type: DEVICE

Triathlon® CR/Neutral Overall Limb Alignment

Total knee replacement using patient-specific cutting guides

Intervention Type: DEVICE

Triathlon® CR/Conventional Limb Alignment

Total knee replacement using traditional instrumentation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabio Catani, Prof.

Role: PRINCIPAL_INVESTIGATOR

Azienada Ospedaliero-Universitaria di Modena

Locations

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, Italy

Azienada Ospedaliero-Universitaria di Modena

Modena, , Italy

Royal Devon and Exeter NHS Foundation Trust

Exeter, Devon, United Kingdom

Countries

Germany; Italy; United Kingdom

Other Identifiers

K-S-045

Identifier Type: -

Identifier Source: org_study_id