Clinical trial NCT05998785: Embody Insertional Achilles Tendinopathy
Official title: A Multi-Center, Prospective Case Series Evaluating Insertional Achilles Tendinopathy Repair Augmented with TAPESTRY® Biointegrative Implant
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Insertional Achilles Tendinopathy
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Embody Inc.
First posted: 2023-08-21
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrolled subjects will include adults with insertional Achilles tendonitis requiring surgery, who meet the study eligibility criteria.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Adult, 21 years and older;
* Insertional Achilles tendonitis requiring surgery that has failed at least 2 weeks of conservative management, which consist of:

  1. Shoe modification; or
  2. Nonsteroidal anti-inflammatory drugs; or
  3. Physical Therapy with/without modalities.
* 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;
* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Pain/VAS
timeFrame: 12 months post-surgery
Secondary outcomes:
measure: Safety/Adverse Events
timeFrame: Surgery, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
measure: Patient Satisfaction
timeFrame: 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
measure: Return to Normal Activity
timeFrame: 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
measure: AOFAS
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
measure: SF-12
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
measure: Tissue Thickness
timeFrame: Baseline and 6 months post-op
Other outcomes:
Locations:
city: Libertyville
country: United States
facility: Weil Foot and Ankle Institute
state: Illinois
city: Tulsa
country: United States
facility: Utica Park Clinic
state: Oklahoma
Study officials:
References: