Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2016-06-03
2019-09-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Treatment with Rotation Medical Bioinductive Implant
Rotation Medical Bioinductive Implant
Placement of bioinductive implant over repair of insertional Achilles tendinopathy
Interventions
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Rotation Medical Bioinductive Implant
Placement of bioinductive implant over repair of insertional Achilles tendinopathy
Eligibility Criteria
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Inclusion Criteria
2. Insertional Achilles tendonitis requiring surgery that has failed conservative management, which consist of:
A. Shoe modification B. Nonsteroidal anti-inflammatory drugs C. Physical Therapy with/without modalities
3. Chronic Achilles tendon pain lasting longer than 3 months
4. MRI or X-ray of the ankle within 60 days prior to the study procedure
5. Willing to comply with the prescribed post-operative rehabilitation program
6. Willing to be available for each protocol-required follow-up examination
7. 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
8. Ability to read, understand, and complete subject-reported outcomes in English
Exclusion Criteria
2. Previous Achilles tendon surgery on the index ankle
3. Genetic collagen disease
4. History of auto-immune or immunodeficiency disorders
5. History of chronic inflammatory disorders
6. Oral steroid use in last 2 months or injectable steroid use in last 4 weeks
7. History of heavy smoking (\> 1 pack per day) within last 6 months
8. Hypersensitivity to bovine-derived materials
9. Hypersensitivity to Polylactic Acid (PLA) and Polyetheretherketone (PEEK) materials
10. Metal implants, fillings, shrapnel, and/or screws
11. Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study
12. Currently involved in any injury litigation or worker's compensation claims relating to the index ankle
13. Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study
14. History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation
15. History of cognitive or mental health status that interferes with study participation
21 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory P Guyton, MD
Role: PRINCIPAL_INVESTIGATOR
MedStar Union Memorial Hospital
Locations
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MedStar Union Memorial Hospital
Baltimore, Maryland, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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3672-01
Identifier Type: -
Identifier Source: org_study_id
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