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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Treatment with Rotation Medical Bioinductive Implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotation Medical Bioinductive Implant | Device | Placement of bioinductive implant over repair of insertional Achilles tendinopathy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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). | following surgery to end of treatment at 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device Implant Time | Time in minutes from introduction of the bioinductive implant into the surgical field to completion of the last staple | Intraoperatively, up to 9 minutes |
| Number of Participants With Procedure Technical Success |
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Inclusion Criteria:
At least 21 years of age
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
Chronic Achilles tendon pain lasting longer than 3 months
MRI or X-ray of the ankle within 60 days prior to the study procedure
Willing to comply with the prescribed post-operative rehabilitation program
Willing to be available for each protocol-required follow-up examination
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
Ability to read, understand, and complete subject-reported outcomes in English
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory P Guyton, MD | MedStar Union Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Union Memorial Hospital | Baltimore | Maryland | 21218 | United States | ||
| Allegheny Health Network |
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There were a total of 20 participants enrolled in the study. The first participant was implanted on 7 June 2016 and the final participant was implanted on 11 August 2017. All participants who were consented and who proceeded to surgery were successfully implanted.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The 3-month MRI for 1 participant did not include the necessary images for thickness measurement; thus, there were only 18 measurements at 3 months. The 12-month MRIs for 3 participants did not include the necessary images for thickness measurement, therefore, there were only 13 measurements at 12 months. The 24-month MRIs for 1 participant did not include the necessary images for thickness measurement, therefore, there were only 15 measurements at 24 months. | Posted | Mean | Standard Deviation | millimeters | 3, 12, and 24 months |
|
Adverse events were collected from the time of surgery through 24 month follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle, tendon and ligament injury | Injury, poisoning and procedural complications | Non-systematic Assessment | Not related to study device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Numbness | Nervous system disorders | Non-systematic Assessment | Not related to study device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samantha Andrews | Smith+Nephew, Inc. | 978.971.8990 | samantha.andrews@smith-nephew.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2016 | Aug 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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The number of participants where the device was successfully delivered and affixed to target tendon location (i.e., study device was successfully implanted).
| Intraoperatively, up to 9 minutes |
| CAM Boot Time | Cumulative number of days spent in a controlled ankle motion walking boot (CAM boot). | 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. | 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). | 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 | 12 months |
| Pittsburgh |
| Pennsylvania |
| 15212 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | inches |
|
| Weight | Mean | Standard Deviation | pounds (lb) |
|
| Study ankle | Count of Participants | Participants |
|
| Smoking history | Count of Participants | Participants |
|
| Duration of Achilles pain | Mean | Standard Deviation | months |
|
Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy |
|
|
| Primary | 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). | The 3-month MRI for 1 participant did not include the necessary images for thickness measurement; thus, there were only 18 measurements at 3 months. The 12-month MRIs for 3 participants did not include the necessary images for thickness measurement, therefore, there were only 13 measurements at 12 months. The 24-month MRIs for 1 participant did not include the necessary images for thickness measurement, therefore, there were only 15 measurements at 24 months. | Posted | Mean | Standard Deviation | millimeters | 3, 12, and 24 months |
|
|
|
| Primary | 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). | Posted | Count of Participants | Participants | following surgery to end of treatment at 24 months |
|
|
|
| Secondary | Device Implant Time | Time in minutes from introduction of the bioinductive implant into the surgical field to completion of the last staple | Posted | Mean | Standard Deviation | minutes | Intraoperatively, up to 9 minutes |
|
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | Intraoperatively, up to 9 minutes |
|
|
|
| Secondary | CAM Boot Time | Cumulative number of days spent in a controlled ankle motion walking boot (CAM boot). | The calculated mean time wearing the boot was based on only 16 patients because 3 patients who wore the boot more than 90 days did not report the actual date they stopped wearing the boot; therefore, the actual time wearing the boot was greater than the calculated mean. | Posted | Mean | Standard Deviation | days | 1 week following surgery to 12 months |
|
|
|
| Secondary | Rehabilitation Visits | Rehabilitation measured by the cumulative number of completed rehabilitation or physical therapy (PT) visits to treat index Achilles. | Overall number of participants analyzed indicates participants that provided data for this outcome measure. | Posted | Mean | Standard Deviation | visits | 4 weeks following surgery to end of treatment at 24 months |
|
|
|
| Secondary | Time to Recovery | Recovery will be measured by days to return to normal daily activity (i.e. full, unrestricted activity). | Overall number of participants analyzed indicates participants that provided data for this outcome measure. | Posted | Mean | Standard Deviation | days | following surgery to end of treatment at 24 months |
|
|
|
| Secondary | 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 | Overall number of participants analyzed that provided data for this outcome measure | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| 4 |
| 20 |
|
| Inversion Injury | Injury, poisoning and procedural complications | Non-systematic Assessment | Not related to study device |
|
| Diabetes | Metabolism and nutrition disorders | Non-systematic Assessment | Not related to study device |
|
| Pacemaker Implanted | Surgical and medical procedures | Non-systematic Assessment | Not related to study device |
|
Not provided
|
| 24 months |
|
|
| Satisfied |
|
| Very satisfied |
|