Arthroplasties, Replacement, KneeNCT02516163

Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using Shapematch Cutting Guides:Sub-Study A

A study testing Shapematch Cutting Guides in people with Arthroplasties, Replacement, Knee, run by Stryker South Pacific.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 90 years
Conditions the study is for: Arthroplasties, Replacement, Knee
What is being tested?: Shapematch Cutting Guides
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: No sites listed yet
Study dates: Dec 2010to Sep 2011
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 50 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient is a male or non-pregnant female between the ages of 50-90.
The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
The patient has a primary diagnosis of osteoarthritis (OA).
The patient has intact collateral ligaments.
The patient is able to undergo MRI scanning of the affected limb.
The patient has signed the study specific, HREC-approved, Informed Consent document.
The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.

Who cannot join

The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
The patient has had a high tibial osteotomy or femoral osteotomy.
The patient is morbidly obese (BMI ≥ 40).
The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical axis).
The patient has a fixed flexion deformity ≥ 15°.

Show all 13Show fewer

The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
The patient has a cognitive impairment, an intellectual disability or a mental illness.
The patient is pregnant.
The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).
The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).

About this study

Official title: A Prospective, Non-randomized,Study of the Clinical Outcomes of Participants That Receive the Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study A

Read the detailed description

This is a prospective, non-randomized, study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides. Sub-study A aims to quantify the reproducibility of intra-operatively positioning the cutting guides onto the affected femoral and tibial joint surfaces.

Conditions: Arthroplasties, Replacement, Knee
Being tested: Shapematch Cutting Guides

What participants receive

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

Shapematch Cutting GuidesDevice
Participants will undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology will be implemented in which the position of the femoral and tibial cutting guides will be measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. Multiple participants will be assessed by each surgeon. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system and associated instruments. No post-operative evaluations will be undertaken as part of this sub-study

Study groups in NCT02516163
Study group	Role	What they receive
Shapematch Cutting Guides	Other	The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting. They are intended for single use only. Receives: Device: Shapematch Cutting Guides

What is being measured

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

Repeatability of Cutting Guide Position
Repeatability of cutting guide position on the distal femur and proximal tibia assessed by repeated measures using computer navigation system for total knee replacement, assessed intra-operatively. Placement of the cutting guides by the surgeon was determined by recording the position of the cutting guide when placed by the same surgeon multiple times. The intraclass correlation coefficient (ICC) was calculated for each positioning parameter. This included femoral and tibial varus/valgus,flexion/extension, medial resection, lateral resection and rotation. ICC agreement categories:>0.75 excellent agreement; 0.75-0.4 good or fair agreement; <0.4 poor agreement.
Measured: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.

Timeline

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

Dec 2010Sep 2011

First posted5 Aug 2015 (estimated)
Study startDec 2010
Primary completionSep 2011
Study completionSep 2011

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 Arthroplasties, 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02516163
Sponsor's protocol ID: TriShapeMatch-10_Substudy A
Status last verified: Sep 2015
First submitted: 3 Aug 2015
Last updated: 12 Jan 2016
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?

Official record

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All Arthroplasties, Replacement, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Non-randomized,Study of the Clinical Outcomes of Participants That Receive the Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study A
ClinicalTrials.gov ID: NCT02516163
Acronym / sponsor ID: TriShapeMatch-10_Substudy A
Conditions: Arthroplasties, Replacement, Knee
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Stryker South PacificIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 5 Aug 2015 (estimated)
Results: Posted 12 Jan 2016

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Shapematch Cutting Guides	Other	Device: Shapematch Cutting GuidesThe ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting. They are intended for single use only.

Who may qualify

Ages: 50 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

The patient is a male or non-pregnant female between the ages of 50-90.
The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
The patient has a primary diagnosis of osteoarthritis (OA).
The patient has intact collateral ligaments.
The patient is able to undergo MRI scanning of the affected limb.

Key exclusion criteria (13 listed)

The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
The patient has had a high tibial osteotomy or femoral osteotomy.
The patient is morbidly obese (BMI ≥ 40).
The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical axis).

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
Shapematch Cutting GuidesParticipants will undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology will be implemented in which the position of the femoral and tibial cutting guides will be measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. Multiple participants will be assessed by each surgeon. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system and associated instruments. No post-operative evaluations will be undertaken as part of this sub-study	Device	Shapematch Cutting Guides

Primary outcome

Repeatability of Cutting Guide Position
Time frame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
Repeatability of cutting guide position on the distal femur and proximal tibia assessed by repeated measures using computer navigation system for total knee replacement, assessed intra-operatively. Placement of the cutting guides by the surgeon was determined by recording the position of the cutting guide when placed by the same surgeon multiple times. The intraclass correlation coefficient (ICC) was calculated for each positioning parameter. This included femoral and tibial varus/valgus,flexion/extension, medial resection, lateral resection and rotation. ICC agreement categories:>0.75 excellent agreement; 0.75-0.4 good or fair agreement; <0.4 poor agreement.

Results and safety

Results posted to the registry on 12 Jan 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
Shapematch Cutting Guides	52	24

Primary outcome: Repeatability of Cutting Guide Position

Time frame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.. Number (95% Confidence Interval). Unit: intraclass correlation coefficient (ICC)

Measure	Shapematch Cutting Guides n = 24
Femur varus/valgus ICC	0.990 (0.980 to 0.995)
Femur flexion/extension ICC	0.963 (0.929 to 0.983)
Femur medial resection ICC	0.936 (0.879 to 0.970)
Femur lateral resection ICC	0.910 (0.832 to 0.957)
Femur rotation ICC	0.993 (0.987 to 0.997)
Tibia varus/valgus ICC	0.994 (0.989 to 0.997)
Tibia flexion/extension ICC	0.961 (0.925 to 0.982)
Tibia medial resection ICC	0.889 (0.795 to 0.946)

Adverse events

Time frame: Intraoperative- participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Shapematch Cutting Guides	2 of 52 (3.8%)	0 of 52 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
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Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
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Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Not yet recruiting
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Enrolling by invitation
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Shapematch Cutting Guides in people with Arthroplasties, Replacement, Knee, run by Stryker South Pacific.

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 7 inclusion and 13 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: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

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 12 Jan 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?

Repeatability of Cutting Guide Position (time frame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.). 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 NCT02516163.

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 12 Jan 2016.