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
Clinical Trials
Rotation Medical Bioinductive Implant Database Registry
The purpose of this clinical registry is to prospectively collect and compare preoperative and postoperative patient-reported data using validated shoulder-specific and health-related qual...
Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
We are testing the efficacy of a new, FDA-approved bioinductive patch in lateral epicondylitis (tennis elbow) patients. A bioinductive patch is an implant that may foster tendon regrowth a...
Identification and Treatment of Early Tendinopathy in Elite Athletes
Tendon injuries represent a significant problem in elite athletes. The understanding of the pathophysiology of tendinopathy is very sparse, and especially the early events in tendinopathy ...
Exercise is a preferred treatment modality for mid-portion achilles tendinopathy. Despite this, as many as 44 % of achilles tendinopathy patients do not respond to exercise treatment. ...
Manual Rotation in Persistent Occiput Posterior Position
Is part of routine obstetric care to attempt a manual rotation in all fetus that are in a persistent OP at delivery. Nevertheless, little is known about the success of this intervention or...
PubMed Articles
Proximal hamstring tendinopathy: pathophysiology, diagnosis and treatment.
Proximal hamstring tendinopathy is a chronic degenerative disease associated with progressive morbidity and functional decline. There is a growing incidence of the disease process but diagnosis is com...
Incidence of Achilles and Patellar Tendinopathy in Adolescent Elite Athletes.
The study investigated the incidence of Achilles and patellar tendinopathy in adolescent elite athletes and non-athletic controls. Furthermore, predictive and associated factors for tendinopathy devel...
Hypersensitivity to orthopaedic implant manifested as erythroderma: Timing of implant removal.
Incidence of hypersensitivity to orthopaedic implant, once estimated in less than 1% of population, recently has increased to 10%. Controversies about the timing of implant removal remain, especially ...
3D FEA Study On Implant Threading Role on Selection of Implant and Crown Materials.
This study deeply investigates the effect of dental implant threading and material selection on the mandibular bone under two different crown materials (Translucent Zirconia and Porcelain fused to met...
The aim of the study was to evaluate the impact of implant component alignment on objective and subjective outcomes after total knee arthroplasty (TKA). The rotation of the femoral component and its i...
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.
