Trials / Completed
CompletedNCT03307499
NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery
Post-market, Prospective Evaluation of Human Placental Membrane Tissue Used as an Adjunct for Foot and Ankle Tendon Surgery in Patients With Chronic Tendinopathy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- CryoLife, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a prospective, single center, postmarket study to evaluate the safety and effectiveness of NeoPatch used as a tissue cover in foot and ankle tendon revision and repair surgery.
Detailed description
This study is a prospective, single center, postmarket study to evaluate the safety and effectiveness of NeoPatch used as a tissue cover for chronically injured tendons requiring surgical revision. NeoPatch is a tissue covering derived from terminally sterilized, dehydrated human placental membrane tissue comprised of both amnion and chorion. Candidates for this study are patients presenting with chronic tendon pain that are being evaluated for primary tendon revision surgery following failure of standard of care or immediate need for surgery, as determined by the investigator. Consented patients will receive NeoPatch as an adjunct to their foot or ankle tendon revision; NeoPatch will be wrapped around the tendon immediately prior to closure. The study will be divided into two phases: Screening and Follow-up. The study will include prospective patient evaluations at scheduled clinic visits and ultrasound appointments for a maximum of 12 visits over 12 months. Patient history, medications, self-reported pain, tendon status, and adverse events will be collected on all patients consented and enrolled into the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | NeoPatch | NeoPatch as an adjunct to foot and ankle tendon revision/repair surgery |
Timeline
- Start date
- 2017-09-21
- Primary completion
- 2018-12-31
- Completion
- 2019-05-15
- First posted
- 2017-10-11
- Last updated
- 2019-05-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03307499. Inclusion in this directory is not an endorsement.