Arthroplasty, Replacement, KneeShapeMatchNCT02539992

ShapeMatch Cutting Guide Functional Outcomes Study

A study testing Triathlon® CR/Kinematic Alignment, Triathlon® CR/Neutral Overall Limb Alignment and Triathlon® CR/Conventional Limb Alignment in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 4 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Arthroplasty, Replacement, Knee
What is being tested?: Triathlon® CR/Kinematic Alignment, Triathlon® CR/Neutral Overall Limb Alignment and Triathlon® CR/Conventional Limb Alignment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 4 sitesin 3 countries
Study dates: May 2012to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 14Show fewer

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.

Trial locations and contacts

4 sites in 3 countries.

Country

City, postcode or hospital

4 sites in 3 countries

Italy2 sites

Istituto Ortopedico Rizzoli
Bologna, Emilia-Romagna, 40136
Azienada Ospedaliero-Universitaria di Modena
Modena, 41124

Other trials in Italy

Germany1 site

Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625

Other trials in Germany

United Kingdom1 site

Royal Devon and Exeter NHS Foundation Trust
Exeter, Devon, EX2 5DW

Other trials in United Kingdom

About this study

Official title: A Prospective, Randomized, Multi-centre Study of the Triathlon Cruciate Retaining Total Knee System Using ShapeMatch Cutting Guides

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

Read the 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
Being tested: Triathlon® CR/Kinematic Alignment, Triathlon® CR/Neutral Overall Limb Alignment, Triathlon® CR/Conventional Limb Alignment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Triathlon® CR/Kinematic AlignmentDevice
Total knee replacement using patient-specific cutting guides
Triathlon® CR/Neutral Overall Limb AlignmentDevice
Total knee replacement using patient-specific cutting guides
Triathlon® CR/Conventional Limb AlignmentDevice
Total knee replacement using traditional instrumentation

Study groups in NCT02539992
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Device: Triathlon® CR/Conventional Limb Alignment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (6)

Investigation of Clinical Performance and Patient Outcome With the Get-up and go Test
Get-up-and-go test uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
One source suggests that scores of ten seconds or less indicate normal mobility, 11 - 20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.
Measured: 1 year
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Measured: 1 year follow-up
Investigation of Clinical Performance and Patient Outcome With the Forgotten Joint Score (FJS) Patient Questionnaire.
The FJS consists of 12 questions and focuses on the patients' awareness of their joint replacement during a range of day to day and recreational activities. The score has a range of 0-100. High scores indicate good outcome, i.e., a high degree of being able to forget about the affected joint in daily life.
Measured: 1 year follow-up
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
The EQ-5D index has an upper bound equal to 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Negative values are allowed, and the lower bound varies depending on country-specific value set used. UK time Trade Off (UKTTO) indicates the patient status compared to the normal state of the UK population.
Measured: 1 year follow-up
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).
The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Measured: 1 year follow-up
Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With Knee Society Score (KSS).
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, Range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
Measured: 1 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012May 2015

First posted3 Sep 2015 (estimated)
Study startMay 2012
Primary completionMay 2015
Study completionMay 2015

Why it stopped: Product discontinued in November 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02539992
Sponsor's protocol ID: K-S-045
Acronym: ShapeMatch
Status last verified: Feb 2024
First submitted: 1 Sep 2015
Last updated: 22 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Knee Arthroplasty, Total, Partial Knee Arthroplasty
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Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
Prosthetic-joint Infection
Not yet recruitingObservational study
Agreement Between Patient-Reported Pain, Observer-Rated Pain Behavior, and Analgesic Request After Total Knee Arthroplasty
Postoperative Pain After Total Knee Arthroplasty
Enrolling by invitationObservational study
Smartphone Video-Based AI Gait Analysis Reports to Support Remote Follow-up After Total Knee Arthroplasty
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All Arthroplasty, Replacement, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Multi-centre Study of the Triathlon Cruciate Retaining Total Knee System Using ShapeMatch Cutting Guides
ClinicalTrials.gov ID: NCT02539992
Acronym / sponsor ID: ShapeMatch / K-S-045
Conditions: Arthroplasty, Replacement, Knee
Study type: Interventional
Recruitment status: TerminatedReason stopped: Product discontinued in November 2014
Enrolment: 44 participants (actual)
Lead sponsor: Stryker OrthopaedicsIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 3 Sep 2015 (estimated)
Results: Posted 16 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Triathlon® CR/Kinematic Alignment	Active comparator	Device: Triathlon® CR/Kinematic AlignmentReceive 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.
Triathlon® CR/Neutral Overall Limb Alignment	Active comparator	Device: Triathlon® CR/Neutral Overall Limb AlignmentReceive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment	Active comparator	Device: Triathlon® CR/Conventional Limb AlignmentReceive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Triathlon® CR/Kinematic AlignmentTotal knee replacement using patient-specific cutting guides	Device	Triathlon® CR/Kinematic Alignment
Triathlon® CR/Neutral Overall Limb AlignmentTotal knee replacement using patient-specific cutting guides	Device	Triathlon® CR/Neutral Overall Limb Alignment
Triathlon® CR/Conventional Limb AlignmentTotal knee replacement using traditional instrumentation	Device	Triathlon® CR/Conventional Limb Alignment

Primary outcome

Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.
Time frame: 6 months
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 secondary outcomes

Investigation of Clinical Performance and Patient Outcome With the Get-up and go Test
Time frame: 1 year
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Time frame: 1 year follow-up
Investigation of Clinical Performance and Patient Outcome With the Forgotten Joint Score (FJS) Patient Questionnaire.
Time frame: 1 year follow-up
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
Time frame: 1 year follow-up
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).
Time frame: 1 year follow-up
Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With Knee Society Score (KSS).
Time frame: 1 year follow-up

Results and safety

Results posted to the registry on 16 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Triathlon® CR/Kinematic Alignment	15	15
Triathlon® CR/Neutral Overall Limb Alignment	11	7
Triathlon® CR/Conventional Limb Alignment	18	14

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

Time frame: 6 months. Mean (Standard Deviation). Unit: Degrees

Measure	Triathlon® CR/Kinematic Alignment n = 6	Triathlon® CR/Neutral Overall Limb Alignment n = 11	Triathlon® CR/Conventional Limb Alignment n = 0
Contact Point Rotation (CPR) Stair Climbing	7.3 (3.5)	8.2 (3.2)	–
CPR Chair Rising	12.6 (2.6)	10.2 (3.7)	–
CPR Extension-Against-Gravity	12.5 (4.2)	8.8 (5.3)	–

Population analysed: Early study termination resulted in limited availability of data for analysis to provide robust, meaningful results. Therefore the fluoroscopic data sets of the Neutral Overall Limb Alignment and Conventional Limb Alignment groups were combined and compared with the Kinematic Alignment group.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Triathlon® CR/Kinematic Alignment	1 of 15 (6.7%)	0 of 15 (0%)	Not reported
Triathlon® CR/Neutral Overall Limb Alignment	4 of 11 (36.4%)	0 of 11 (0%)	Not reported
Triathlon® CR/Conventional Limb Alignment	2 of 18 (11.1%)	0 of 18 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Arthroplasty, Replacement, Knee

Active, not recruiting
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
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Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
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Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
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Agreement Between Patient-Reported Pain, Observer-Rated Pain Behavior, and Analgesic Request After Total Knee Arthroplasty
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Enrolling by invitationObservational study
Smartphone Video-Based AI Gait Analysis Reports to Support Remote Follow-up After Total Knee Arthroplasty
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fabio Catani, Prof. principal investigator

Azienada Ospedaliero-Universitaria di Modena

4 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02539992.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.