Insertional Achilles TendinopathyIATNCT05998785
Embody Insertional Achilles Tendinopathy
An observational study of Insertional Achilles Tendinopathy, run by Zimmer Biomet at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the long-term effects on ankle/Achilles tendon pain after repair of insertional Achilles tendinopathy (IAT) augmented with TAPESTRY Biointegrative Implant. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Insertional Achilles Tendinopathy
- What is being tested?
- TAPESTRY Biointegrative Implant
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Aug 2022to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Enrolled subjects will include adults with insertional Achilles tendonitis requiring surgery, who meet the study eligibility criteria.
Who may be able to join
- Adult, 21 years and older;
- Insertional Achilles tendonitis requiring surgery that has failed at least 2 weeks of conservative management, which consist of:
- Shoe modification; or
- Nonsteroidal anti-inflammatory drugs; or
- Physical Therapy with/without modalities.
- Chronic Achilles tendon pain lasting longer than 3 months;
Show all 11Show fewer
- MRI of the ankle within 30 days prior to the study surgery;
- Ability and willingness to comply with prescribed post-operative rehabilitation program;
- Ability and willingness to comply with follow-up regimen;
- 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; and
- Ability to read, understand, and complete subject-reported outcomes in English.
Who cannot join
- History of Achilles tendon rupture;
- Previous Achilles tendon surgery on the index ankle;
- Genetic collagen disease, hypersensitivity, or objection to using bovine-derived materials;
- 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 13Show fewer
- History of heavy smoking (> 1 pack per day) within last 6 months;
- Hypersensitivity to poly(D,L-lactide) 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 studythat would affect the outcomes of this study; or
- History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Weil Foot and Ankle Institute
Libertyville, Illinois, 60048
Utica Park Clinic
Tulsa, Oklahoma, 74104
About this study
Official title: A Multi-Center, Prospective Case Series Evaluating Insertional Achilles Tendinopathy Repair Augmented with TAPESTRY® Biointegrative Implant
The primary objective of this study is to evaluate the long-term effects on ankle/Achilles tendon pain after repair of insertional Achilles tendinopathy (IAT) augmented with TAPESTRY Biointegrative Implant.
Read the detailed description
This study is a prospective case series of patients who have had insertional Achilles tendinopathy repair augmented with the Tapestry Biointegrative Implant. The primary aim of the study is to describe patient reported pain 12 months after surgical repair with Tapestry. The secondary aims are to assess the proportion of study subjects that experience treatment-related adverse events post-surgery, treatment related serious adverse events resulting in second surgical intervention, quality of life and other patient reported outcomes at all follow up timepoints post-surgery, and tissue thickness measured with MRI at 6 months post-surgery.
- Conditions
- Insertional Achilles Tendinopathy
- Being tested
- TAPESTRY Biointegrative Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAPESTRY Biointegrative ImplantDevice
Collagen-based implant composed of type I bovine collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. Preclinical studies of the Tapestry implant showed dense collagenous fibrous connective tissue ingrowth into and around the implant.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain/VAS
Visual Analog Scale (VAS) survey
Measured: 12 months post-surgery
Secondary outcomes (6)
Safety/Adverse Events
- Procedure and/or treatment related adverse events;
- Procedure and/or treatment related Serious Adverse Events (SAE)
- Procedure and/or treatment related Serious Adverse Events (SAE) necessitating a second surgical intervention (SSI);
Measured: Surgery, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
Patient Satisfaction
Patient Satisfaction Survey
Measured: 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
Return to Normal Activity
Return to Normal Activity survey
Measured: 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
AOFAS
American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot questionnaire
Measured: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
SF-12
12-item Short Form- Health Survey
Measured: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
Tissue Thickness
MRI tissue thickness of the Achilles tendon at baseline and 6 months post-surgery. Tissue thickness will be measured by trained personnel per the EMBODY-002 MRI procedure manual.
Measured: Baseline and 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start2 Aug 2022
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Why it stopped: Administrative issues with IRB, none of which impacted the health/safety/welfare of the subjects, has resulted in enrollment suspension and subsequent study termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insertional Achilles TendinopathyStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Embody Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998785
- Sponsor's protocol ID
- EMBODY-002
- Acronym
- IAT
- Status last verified
- Dec 2024
- First submitted
- 11 Aug 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective Case Series Evaluating Insertional Achilles Tendinopathy Repair Augmented with TAPESTRY® Biointegrative Implant
- ClinicalTrials.gov ID
- NCT05998785
- Acronym / sponsor ID
- IAT / EMBODY-002
- Conditions
- Insertional Achilles Tendinopathy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Administrative issues with IRB, none of which impacted the health/safety/welfare of the subjects, has resulted in enrollment suspension and subsequent study termination.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Embody Inc.
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the long-term effects on ankle/Achilles tendon pain after repair of insertional Achilles tendinopathy (IAT) augmented with TAPESTRY Biointegrative Implant.
Detailed description
This study is a prospective case series of patients who have had insertional Achilles tendinopathy repair augmented with the Tapestry Biointegrative Implant. The primary aim of the study is to describe patient reported pain 12 months after surgical repair with Tapestry. The secondary aims are to assess the proportion of study subjects that experience treatment-related adverse events post-surgery, treatment related serious adverse events resulting in second surgical intervention, quality of life and other patient reported outcomes at all follow up timepoints post-surgery, and tissue thickness measured with MRI at 6 months post-surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Enrolled subjects will include adults with insertional Achilles tendonitis requiring surgery, who meet the study eligibility criteria.
Key inclusion criteria (11 listed)
- Adult, 21 years and older;
- Insertional Achilles tendonitis requiring surgery that has failed at least 2 weeks of conservative management, which consist of:
- Chronic Achilles tendon pain lasting longer than 3 months;
- MRI of the ankle within 30 days prior to the study surgery;
- Ability and willingness to comply with prescribed post-operative rehabilitation program;
Key exclusion criteria (13 listed)
- History of Achilles tendon rupture;
- Previous Achilles tendon surgery on the index ankle;
- Genetic collagen disease, hypersensitivity, or objection to using bovine-derived materials;
- 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 |
|---|---|---|
| TAPESTRY Biointegrative ImplantCollagen-based implant composed of type I bovine collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. Preclinical studies of the Tapestry implant showed dense collagenous fibrous connective tissue ingrowth into and around the implant. | Device | – |
Primary outcome
Pain/VAS
Time frame: 12 months post-surgery
Visual Analog Scale (VAS) survey
6 secondary outcomes
Safety/Adverse Events
Time frame: Surgery, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
Patient Satisfaction
Time frame: 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
Return to Normal Activity
Time frame: 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
AOFAS
Time frame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
SF-12
Time frame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
Tissue Thickness
Time frame: Baseline and 6 months post-op
Results and safety
The study was stopped early (reason given: Administrative issues with IRB, none of which impacted the health/safety/welfare of the subjects, has resulted in enrollment suspension and subsequent study termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Insertional Achilles Tendinopathy
Not yet recruitingObservational study
Open Versus Fully Endoscopic Calcaneoplasty With Achilles Tendon Insertional Reconstruction for Haglund Syndrome
Haglund Syndrome, Insertional Achilles Tendinopathy
Recruiting
Single-Row Versus Double-Row Repair for Achilles Insertional Tendinopathy
Achilles Insertional Tendinopathy, Achilles Tendinopathy
Recruiting
Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.
Tendinopathy, Insertional Achilles Tendinopathy
Active, not recruiting
Augmenting Standard Rehabilitation With Blood Flow Restriction for Chronic Achilles Tendinopathy
Achilles Tendinopathy (AT)
Not yet recruiting
Achilles Tendinopathy; the Effect of Shockwave Treatment
Achilles Tendinopathy (AT), Achilles Tendon
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insertional Achilles Tendinopathy, run by Zimmer Biomet 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 11 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: stopped early, as of the sponsor's last update on 20 Dec 2024. 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?
The study was stopped early (reason given: Administrative issues with IRB, none of which impacted the health/safety/welfare of the subjects, has resulted in enrollment suspension and subsequent study termination.). Results are not available in the source record.
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?
Pain/VAS (time frame: 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2024.