TendinopathyNCT02811003

Achilles Tendon Repair With Bioinductive Implant

A study testing Rotation Medical Bioinductive Implant in people with Tendinopathy, run by Smith & Nephew, Inc. at 2 sites in United States.

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

To evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as adjunct to surgical repair in the treatment of insertional Achilles tendonitis. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Tendinopathy
What is being tested?: Rotation Medical Bioinductive Implant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 2 sitesUnited States
Study dates: 3 Jun 2016to 17 Sep 2019
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

At least 21 years of age
Insertional Achilles tendonitis requiring surgery that has failed conservative management, which consist of:
Shoe modification B. Nonsteroidal anti-inflammatory drugs C. Physical Therapy with/without modalities
Chronic Achilles tendon pain lasting longer than 3 months
MRI or X-ray of the ankle within 60 days prior to the study procedure
Willing to comply with the prescribed post-operative rehabilitation program

Show all 9Show fewer

Willing to be available for each protocol-required follow-up examination
Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures
Ability to read, understand, and complete subject-reported outcomes in English

Who cannot join

Achilles tendon rupture
Previous Achilles tendon surgery on the index ankle
Genetic collagen disease
History of auto-immune or immunodeficiency disorders
History of chronic inflammatory disorders
Oral steroid use in last 2 months or injectable steroid use in last 4 weeks

Show all 15Show fewer

History of heavy smoking (> 1 pack per day) within last 6 months
Hypersensitivity to bovine-derived materials
Hypersensitivity to Polylactic Acid (PLA) and Polyetheretherketone (PEEK) materials
Metal implants, fillings, shrapnel, and/or screws
Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study
Currently involved in any injury litigation or worker's compensation claims relating to the index ankle
Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study
History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation
History of cognitive or mental health status that interferes with study participation

Trial locations and contacts

2 sites in 1 country.

United States2 sites

MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212

Other trials in United States

About this study

Official title: Evaluation of the Rotation Medical Bioinductive Implant for Insertional Achilles Tendinopathy

Read the detailed description

This is a prospective, non-randomized, single-arm study conducted under a common protocol designed to evaluate long-term outcomes following open treatment and implantation of the Rotation Medical Bioinductive Implant to treat insertional Achilles tendinopathy.

Up to 20 subjects will be enrolled and treated with the Rotation Medical Bioinductive Implant.

Enrollment is anticipated to take up to 12 months and all subjects will be followed for two years after surgery. Therefore, the overall study duration is estimated to be 36 months.

Conditions: Tendinopathy
Being tested: Rotation Medical Bioinductive Implant
Keywords: Insertional Achilles
Medical subject headings: Tendinopathy

What participants receive

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

Rotation Medical Bioinductive ImplantDevice
Placement of bioinductive implant over repair of insertional Achilles tendinopathy

Study groups in NCT02811003
Study group	Role	What they receive
Treatment	Experimental	Treatment with Rotation Medical Bioinductive Implant Receives: Device: Rotation Medical Bioinductive Implant

What is being measured

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

New Tissue Thickness
Measurement of new tissue thickness in millimeters will be made from sagittal magnetic resonance imaging (MRI) at the level of the bone anchor. These measurements were made distal to the attachment of the Achilles tendon, which do not include the thickness of the repaired tendon; therefore, these thicknesses represent the thickness of the newly induced tissue only.
Measured: 3, 12, and 24 months
MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue)
Combined measurement of tendon and new tissue thickness in millimeters will be made from sagittal magnetic resonance imaging (MRI) at the insertion (approximately 5-10mm proximal to the bone anchor).
Measured: 3, 12, and 24 months
Tear Rate
Tear rate in the deep portion of the repair at the calcaneus following Achilles surgery will be assessed at each follow-up visit using magnetic resonance imaging (MRI).
Measured: following surgery to end of treatment at 24 months

Secondary outcomes (6)

Device Implant Time
Time in minutes from introduction of the bioinductive implant into the surgical field to completion of the last staple
Measured: Intraoperatively, up to 9 minutes
Number of Participants With Procedure Technical Success
The number of participants where the device was successfully delivered and affixed to target tendon location (i.e., study device was successfully implanted).
Measured: Intraoperatively, up to 9 minutes
CAM Boot Time
Cumulative number of days spent in a controlled ankle motion walking boot (CAM boot).
Measured: 1 week following surgery to 12 months
Rehabilitation Visits
Rehabilitation measured by the cumulative number of completed rehabilitation or physical therapy (PT) visits to treat index Achilles.
Measured: 4 weeks following surgery to end of treatment at 24 months
Time to Recovery
Recovery will be measured by days to return to normal daily activity (i.e. full, unrestricted activity).
Measured: following surgery to end of treatment at 24 months
Participant Satisfaction
Participant Satisfaction will determined based on the response to the statement "I am satisfied with the results of my surgery." The response will be assessed with a 5-point Likert scale, which has 1 - very dissatisfied, 2 - dissatisfied, 3 - neither satisfied nor dissatisfied, 4 - satisfied, 5 - very satisfied
Measured: 12 months

Timeline

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

3 Jun 201617 Sep 2019

First posted23 Jun 2016 (estimated)
Study start3 Jun 2016
Primary completion17 Sep 2019
Study completion17 Sep 2019

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 TendinopathyStudies of the same condition, open and under way.
More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02811003
Sponsor's protocol ID: 3672-01
Status last verified: Mar 2019
First submitted: 14 Jun 2016
Last updated: 4 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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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All Tendinopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Rotation Medical Bioinductive Implant for Insertional Achilles Tendinopathy
ClinicalTrials.gov ID: NCT02811003
Acronym / sponsor ID: 3672-01
Conditions: Tendinopathy
Keywords: Insertional Achilles
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 3 Jun 2016 (actual)
Primary completion: 17 Sep 2019 (actual)
Study completion: 17 Sep 2019 (actual)
First posted: 23 Jun 2016 (estimated)
Results: Posted 4 Nov 2022

Clinical summary

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

Detailed description

Up to 20 subjects will be enrolled and treated with the Rotation Medical Bioinductive Implant.

Enrollment is anticipated to take up to 12 months and all subjects will be followed for two years after surgery. Therefore, the overall study duration is estimated to be 36 months.

Study design

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

Arm	Type	Receives
Treatment	Experimental	Device: Rotation Medical Bioinductive ImplantTreatment with Rotation Medical Bioinductive Implant

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

At least 21 years of age
Insertional Achilles tendonitis requiring surgery that has failed conservative management, which consist of:
Chronic Achilles tendon pain lasting longer than 3 months
MRI or X-ray of the ankle within 60 days prior to the study procedure
Willing to comply with the prescribed post-operative rehabilitation program

Key exclusion criteria (15 listed)

Achilles tendon rupture
Previous Achilles tendon surgery on the index ankle
Genetic collagen disease
History of auto-immune or immunodeficiency disorders
History of chronic inflammatory disorders

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
Rotation Medical Bioinductive ImplantPlacement of bioinductive implant over repair of insertional Achilles tendinopathy	Device	Treatment

Primary outcome

New Tissue Thickness
Time frame: 3, 12, and 24 months
Measurement of new tissue thickness in millimeters will be made from sagittal magnetic resonance imaging (MRI) at the level of the bone anchor. These measurements were made distal to the attachment of the Achilles tendon, which do not include the thickness of the repaired tendon; therefore, these thicknesses represent the thickness of the newly induced tissue only.
MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue)
Time frame: 3, 12, and 24 months
Combined measurement of tendon and new tissue thickness in millimeters will be made from sagittal magnetic resonance imaging (MRI) at the insertion (approximately 5-10mm proximal to the bone anchor).
Tear Rate
Time frame: following surgery to end of treatment at 24 months
Tear rate in the deep portion of the repair at the calcaneus following Achilles surgery will be assessed at each follow-up visit using magnetic resonance imaging (MRI).

6 secondary outcomes

Device Implant Time
Time frame: Intraoperatively, up to 9 minutes
Number of Participants With Procedure Technical Success
Time frame: Intraoperatively, up to 9 minutes
CAM Boot Time
Time frame: 1 week following surgery to 12 months
Rehabilitation Visits
Time frame: 4 weeks following surgery to end of treatment at 24 months
Time to Recovery
Time frame: following surgery to end of treatment at 24 months
Participant Satisfaction
Time frame: 12 months

Results and safety

Results posted to the registry on 4 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	20	15

Primary outcome: New Tissue Thickness

Time frame: 3, 12, and 24 months. Mean (Standard Deviation). Unit: millimeters

Measure	Treatment n = 18
3 months	5.40 (1.08)
12 months	5.70 (0.78)
24 months	5.50 (0.92)

Population analysed: The 3-month MRI for 1 participant did not include the necessary images for thickness measurement; thus, there were only 18 measurements at 3 months. The 12-month MRIs for 3 participants did not include the necessary images for thickness measurement, therefore, there were only 13 measurements at 12 months. The 24-month MRIs for 1 participant did not include the necessary images for thickness measurement, therefore, there were only 15 measurements at 24 months.

Primary outcome: MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue)

Time frame: 3, 12, and 24 months. Mean (Standard Deviation). Unit: millimeters

Measure	Treatment n = 18
3 months	8.20 (2.47)
12 months	16.80 (4.58)
24 months	18.40 (2.84)

Primary outcome: Tear Rate

Time frame: following surgery to end of treatment at 24 months. Count of participants. Unit: Participants

Measure	Treatment n = 20
No Tear	17
Tear	3

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of surgery through 24 month follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	1 of 20 (5%)	4 of 20 (20%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Tendinopathy

Recruiting
Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
RecruitingObservational study
Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
Tendinopathy
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Active, not recruiting
Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries

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.

Gregory P Guyton, MD principal investigator

MedStar Union Memorial Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Rotation Medical Bioinductive Implant in people with Tendinopathy, run by Smith & Nephew, Inc. at 2 sites in United States.

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 9 inclusion and 15 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 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 4 Nov 2022). 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?

New Tissue Thickness (time frame: 3, 12, and 24 months). The study lists 3 primary outcomes in all. 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 NCT02811003.

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 4 Nov 2022.