Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-01 @ 12:50 PM
Study NCT ID:
NCT02811003
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2016-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Achilles Tendon Repair With Bioinductive Implant
Sponsor:
Smith & Nephew, Inc.
Organization:
Study Overview
Official Title:
Evaluation of the Rotation Medical Bioinductive Implant for Insertional Achilles Tendinopathy
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: