ShapeMatch Cutting Guide Functional Outcomes Study

NCT02539992 | Terminated Results

• 1 other identifier: K-S-045
• Study Type: interventional
• Target: 44
• Locations: 3 countries
• Sites: 4

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.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.

  To demonstrate by means of fluoroscopy that TKR's performed using a kinematic aligned ShapeMatch Cutting Guide provides better short term kinematic and functional performance compared to those TKR's performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall limb alignment.

  6 months

Secondary Outcomes (6)

• Investigation of Clinical Performance and Patient Outcome With the Get-up and go Test

  1 year

• Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.

  1 year follow-up

• Investigation of Clinical Performance and Patient Outcome With the Forgotten Joint Score (FJS) Patient Questionnaire.

  1 year follow-up

• Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).

  1 year follow-up

• Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).

  1 year follow-up

Study Arms (3)

Triathlon® CR/Kinematic Alignment

ACTIVE COMPARATOR

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.

Device: Triathlon® CR/Kinematic Alignment

Triathlon® CR/Neutral Overall Limb Alignment

ACTIVE COMPARATOR

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

Device: Triathlon® CR/Neutral Overall Limb Alignment

Triathlon® CR/Conventional Limb Alignment

ACTIVE COMPARATOR

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

Device: Triathlon® CR/Conventional Limb Alignment

Interventions

Triathlon® CR/Kinematic Alignment DEVICE

Total knee replacement using patient-specific cutting guides

Triathlon® CR/Kinematic Alignment

Triathlon® CR/Neutral Overall Limb Alignment DEVICE

Total knee replacement using patient-specific cutting guides

Triathlon® CR/Neutral Overall Limb Alignment

Triathlon® CR/Conventional Limb Alignment DEVICE

Total knee replacement using traditional instrumentation

Triathlon® CR/Conventional Limb Alignment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (4)

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40136, Italy

Location

Azienada Ospedaliero-Universitaria di Modena

Modena, 41124, Italy

Location

Royal Devon and Exeter NHS Foundation Trust

Exeter, Devon, EX2 5DW, United Kingdom

Location

Limitations and Caveats

Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.

Results Point of Contact

• Title: Dr. Eric Garling, Director Medical & Scientific Affairs Europe
• Organization: Stryker European Operations BV

eric.garling@stryker.com

+31 20 219 2660

Study Officials

• Fabio Catani, Prof.

  Azienada Ospedaliero-Universitaria di Modena

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 3, 2015
• Study Start: May 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 22, 2024
• Results First Posted: May 16, 2016

Record last verified: 2024-02

Locations

DE (1); IT (2); GB (1)