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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Placement of bioinductive implant over repair of insertional Achilles tendinopathy
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
New Tissue Thickness
Measurement of new tissue thickness in millimeters will be made from sagittal magnetic resonance imaging (MRI) at the level of the bone anchor. These measurements were made distal to the attachment of the Achilles tendon, which do not include the thickness of the repaired tendon; therefore, these thicknesses represent the thickness of the newly induced tissue only.
Time frame: 3, 12, and 24 months
MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue)
Combined measurement of tendon and new tissue thickness in millimeters will be made from sagittal magnetic resonance imaging (MRI) at the insertion (approximately 5-10mm proximal to the bone anchor).
Time frame: 3, 12, and 24 months
Tear Rate
Tear rate in the deep portion of the repair at the calcaneus following Achilles surgery will be assessed at each follow-up visit using magnetic resonance imaging (MRI).
Time frame: following surgery to end of treatment at 24 months
Device Implant Time
Time in minutes from introduction of the bioinductive implant into the surgical field to completion of the last staple
Time frame: Intraoperatively, up to 9 minutes
Number of Participants With Procedure Technical Success
The number of participants where the device was successfully delivered and affixed to target tendon location (i.e., study device was successfully implanted).
Time frame: Intraoperatively, up to 9 minutes
CAM Boot Time
Cumulative number of days spent in a controlled ankle motion walking boot (CAM boot).
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Time frame: 1 week following surgery to 12 months
Rehabilitation Visits
Rehabilitation measured by the cumulative number of completed rehabilitation or physical therapy (PT) visits to treat index Achilles.
Time frame: 4 weeks following surgery to end of treatment at 24 months
Time to Recovery
Recovery will be measured by days to return to normal daily activity (i.e. full, unrestricted activity).
Time frame: following surgery to end of treatment at 24 months
Participant Satisfaction
Participant Satisfaction will determined based on the response to the statement "I am satisfied with the results of my surgery." The response 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
Time frame: 12 months