Clinical trial NCT02539992: ShapeMatch Cutting Guide Functional Outcomes Study
Official title: A Prospective, Randomized, Multi-centre Study of the Triathlon Cruciate Retaining Total Knee System Using ShapeMatch Cutting Guides
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2015-09-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.
timeFrame: 6 months
Secondary outcomes:
measure: Investigation of Clinical Performance and Patient Outcome With the Get-up and go Test
timeFrame: 1 year
measure: Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
timeFrame: 1 year follow-up
measure: Investigation of Clinical Performance and Patient Outcome With the Forgotten Joint Score (FJS) Patient Questionnaire.
timeFrame: 1 year follow-up
measure: Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
timeFrame: 1 year follow-up
measure: Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).
timeFrame: 1 year follow-up
measure: Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With Knee Society Score (KSS).
timeFrame: 1 year follow-up
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: Emilia-Romagna
city: Modena
country: Italy
facility: Azienada Ospedaliero-Universitaria di Modena
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
state: Devon
Study officials:
affiliation: Azienada Ospedaliero-Universitaria di Modena
name: Fabio Catani, Prof.
role: PRINCIPAL_INVESTIGATOR
References: