Achilles Tendon Repair With Bioinductive Implant
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02811003|
Recruitment Status : Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tendinopathy||Device: Rotation Medical Bioinductive Implant||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Rotation Medical Bioinductive Implant for Insertional Achilles Tendinopathy|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
Treatment with Rotation Medical Bioinductive Implant
Device: Rotation Medical Bioinductive Implant
Placement of bioinductive implant over repair of insertional Achilles tendinopathy
- Thickness of new tissue induction [ Time Frame: 12 months ]Measurement of tissue thickness in millimeters will be made from sagittal MRI images.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 24 months ]Adverse events
- Recovery [ Time Frame: 12 months ]Recovery will be measured by days to return to work or normal activity.
- Patient Satisfaction [ Time Frame: 24 months ]Patient Satisfaction will be assessed with a 5-point Likert scale, which has 1 - very dissatisfied, 2 - dissatisfied, 3 - neither satisfied nor dissatisfied, 4 - satisfied, 5 - very satisfied
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811003
|United States, Maryland|
|MedStar Union Memorial Hospital|
|Baltimore, Maryland, United States, 21218|
|United States, Pennsylvania|
|Allegheny Health Network|
|Pittsburgh, Pennsylvania, United States, 15212|
|Principal Investigator:||Gregory P Guyton, MD||MedStar Union Memorial Hospital|