Tendinopathy
Conditions
Keywords
Insertional Achilles
Brief 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.
Detailed 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 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.
Interventions
DEVICERotation Medical Bioinductive Implant
Placement of bioinductive implant over repair of insertional Achilles tendinopathy
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 21 years of age 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
1. Achilles tendon rupture 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New Tissue Thickness | 3, 12, and 24 months | 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. |
| MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue) | 3, 12, and 24 months | 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). |
| Tear Rate | following surgery to end of treatment at 24 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CAM Boot Time | 1 week following surgery to 12 months | Cumulative number of days spent in a controlled ankle motion walking boot (CAM boot). |
| Time to Recovery | following surgery to end of treatment at 24 months | Recovery will be measured by days to return to normal daily activity (i.e. full, unrestricted activity). |
| Participant Satisfaction | 12 months | 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 |
| Rehabilitation Visits | 4 weeks following surgery to end of treatment at 24 months | Rehabilitation measured by the cumulative number of completed rehabilitation or physical therapy (PT) visits to treat index Achilles. |
| Device Implant Time | Intraoperatively, up to 9 minutes | Time in minutes from introduction of the bioinductive implant into the surgical field to completion of the last staple |
| Number of Participants With Procedure Technical Success | Intraoperatively, up to 9 minutes | The number of participants where the device was successfully delivered and affixed to target tendon location (i.e., study device was successfully implanted). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Treatment with Rotation Medical Bioinductive Implant
Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 51.60 years STANDARD_DEVIATION 6.76 |
| Duration of Achilles pain | 18.10 months STANDARD_DEVIATION 11.92 |
| Height | 68.30 inches STANDARD_DEVIATION 4.5 |
| Race/Ethnicity, Customized African American | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 17 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
| Smoking history Current | 1 Participants |
| Smoking history Former | 5 Participants |
| Smoking history Never | 14 Participants |
| Study ankle Left | 10 Participants |
| Study ankle Right | 10 Participants |
| Weight | 213.30 pounds (lb) STANDARD_DEVIATION 38.58 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 4 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
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).
Time frame: 3, 12, and 24 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue) | 3 months | 8.20 millimeters | Standard Deviation 2.47 |
| Treatment | MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue) | 12 months | 16.80 millimeters | Standard Deviation 4.58 |
| Treatment | MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue) | 24 months | 18.40 millimeters | Standard Deviation 2.84 |
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.
Time frame: 3, 12, and 24 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | New Tissue Thickness | 3 months | 5.40 millimeters | Standard Deviation 1.08 |
| Treatment | New Tissue Thickness | 12 months | 5.70 millimeters | Standard Deviation 0.78 |
| Treatment | New Tissue Thickness | 24 months | 5.50 millimeters | Standard Deviation 0.92 |
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).
Time frame: following surgery to end of treatment at 24 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment | Tear Rate | No Tear | 17 Participants |
| Treatment | Tear Rate | Tear | 3 Participants |
Secondary
CAM Boot Time
Cumulative number of days spent in a controlled ankle motion walking boot (CAM boot).
Time frame: 1 week following surgery to 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | CAM Boot Time | 76.30 days | Standard Deviation 29.32 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Device Implant Time | 5.40 minutes | Standard Deviation 1.57 |
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).
Time frame: Intraoperatively, up to 9 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment | Number of Participants With Procedure Technical Success | Device Successfully Implanted | 20 Participants |
| Treatment | Number of Participants With Procedure Technical Success | Device Not Successfully Implanted | 0 Participants |
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
Time frame: 12 months
Population: Overall number of participants analyzed that provided data for this outcome measure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment | Participant Satisfaction | Very dissatisfied | 1 Participants |
| Treatment | Participant Satisfaction | Dissatisfied | 1 Participants |
| Treatment | Participant Satisfaction | Neither satisfied nor dissatisfied | 1 Participants |
| Treatment | Participant Satisfaction | Satisfied | 7 Participants |
| Treatment | Participant Satisfaction | Very satisfied | 7 Participants |
Secondary
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
Population: Overall number of participants analyzed indicates participants that provided data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Rehabilitation Visits | 17.90 visits | Standard Deviation 8.33 |
Secondary
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
Population: Overall number of participants analyzed indicates participants that provided data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Time to Recovery | 167.80 days | Standard Deviation 68.04 |