Achilles Tendon Repair With Bioinductive Implant
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.
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 10 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
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Tendinopathy
Intervention
Rotation Medical Bioinductive Implant
Location
MedStar Union Memorial Hospital
Baltimore
Maryland
United States
21218
Status
Enrolling by invitation
Source
Rotation Medical, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT02811003
- ClinicalTrials.gov processed this data on June 22, 2016
Published on BioPortfolio: 2016-06-23T19:08:22-0400
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Medical and Biotech [MESH] Definitions
Optical Rotation
The rotation of linearly polarized light as it passes through various media.
Dental Implantation, Endosseous
Insertion of an implant into the bone of the mandible or maxilla. The implant has an exposed head which protrudes through the mucosa and is a prosthodontic abutment.
Immediate Dental Implant Loading
Endosseous dental implantation where implants are fitted with an abutment or where an implant with a transmucosal coronal portion is used immediately (within 1 week) after the initial extraction. Conventionally, the implantation is performed in two stages with more than two months in between the stages.
Dental Implant-abutment Design
The plan and delineation of DENTAL IMPLANT fitting with DENTAL ABUTMENT.
Elbow Tendinopathy
Inflammation (tendinitis) or degeneration (tendinosis) of the tendons of the elbow.
