Trial Outcomes & Findings for Achilles Tendon Repair With Bioinductive Implant (NCT NCT02811003)

NCT ID: NCT02811003

Last Updated: 2022-11-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 3, 12, and 24 months
• Results posted on: 2022-11-04

Participant Flow

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.

Participant milestones

Measure	Treatment Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy
Overall Study STARTED	20
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Achilles Tendon Repair With Bioinductive Implant

Baseline characteristics by cohort

Measure	Treatment n=20 Participants Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy
Age, Continuous	51.60 years STANDARD_DEVIATION 6.76 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	17 Participants n=5 Participants
Race/Ethnicity, Customized African American	3 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
Height	68.30 inches STANDARD_DEVIATION 4.50 • n=5 Participants
Weight	213.30 pounds (lb) STANDARD_DEVIATION 38.58 • n=5 Participants
Study ankle Left	10 Participants n=5 Participants
Study ankle Right	10 Participants n=5 Participants
Smoking history Never	14 Participants n=5 Participants
Smoking history Former	5 Participants n=5 Participants
Smoking history Current	1 Participants n=5 Participants
Duration of Achilles pain	18.10 months STANDARD_DEVIATION 11.92 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Treatment n=18 Participants Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy
New Tissue Thickness 3 months	5.40 millimeters Standard Deviation 1.08
New Tissue Thickness 12 months	5.70 millimeters Standard Deviation 0.78
New Tissue Thickness 24 months	5.50 millimeters Standard Deviation 0.92

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Treatment n=18 Participants Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy
MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue) 3 months	8.20 millimeters Standard Deviation 2.47
MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue) 12 months	16.80 millimeters Standard Deviation 4.58
MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue) 24 months	18.40 millimeters Standard Deviation 2.84

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Treatment n=20 Participants Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy
Tear Rate No Tear	17 Participants
Tear Rate Tear	3 Participants

SECONDARY outcome

Timeframe: Intraoperatively, up to 9 minutes

Time in minutes from introduction of the bioinductive implant into the surgical field to completion of the last staple

Outcome measures

Measure	Treatment n=20 Participants Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy
Device Implant Time	5.40 minutes Standard Deviation 1.57

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Treatment n=20 Participants Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy
Number of Participants With Procedure Technical Success Device Successfully Implanted	20 Participants
Number of Participants With Procedure Technical Success Device Not Successfully Implanted	0 Participants

SECONDARY outcome

Timeframe: 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.

Cumulative number of days spent in a controlled ankle motion walking boot (CAM boot).

Outcome measures

Measure	Treatment n=16 Participants Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy
CAM Boot Time	76.30 days Standard Deviation 29.32

SECONDARY outcome

Timeframe: 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.

Rehabilitation measured by the cumulative number of completed rehabilitation or physical therapy (PT) visits to treat index Achilles.

Outcome measures

Measure	Treatment n=10 Participants Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy
Rehabilitation Visits	17.90 visits Standard Deviation 8.33

SECONDARY outcome

Timeframe: following surgery to end of treatment at 24 months

Population: Overall number of participants analyzed indicates participants that provided data for this outcome measure.

Recovery will be measured by days to return to normal daily activity (i.e. full, unrestricted activity).

Outcome measures

Measure	Treatment n=10 Participants Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy
Time to Recovery	167.80 days Standard Deviation 68.04

SECONDARY outcome

Timeframe: 12 months

Population: Overall number of participants analyzed that provided data for this outcome measure

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

Outcome measures

Measure	Treatment n=17 Participants Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy
Participant Satisfaction Very dissatisfied	1 Participants
Participant Satisfaction Dissatisfied	1 Participants
Participant Satisfaction Neither satisfied nor dissatisfied	1 Participants
Participant Satisfaction Satisfied	7 Participants
Participant Satisfaction Very satisfied	7 Participants

Adverse Events

Treatment

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=20 participants at risk Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy
Injury, poisoning and procedural complications Muscle, tendon and ligament injury	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of surgery through 24 month follow-up.

Other adverse events

Measure	Treatment n=20 participants at risk Treatment with Rotation Medical Bioinductive Implant Rotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy
Nervous system disorders Numbness	5.0% 1/20 • Number of events 2 • Adverse events were collected from the time of surgery through 24 month follow-up.
Injury, poisoning and procedural complications Inversion Injury	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of surgery through 24 month follow-up.
Metabolism and nutrition disorders Diabetes	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of surgery through 24 month follow-up.
Surgical and medical procedures Pacemaker Implanted	5.0% 1/20 • Number of events 1 • Adverse events were collected from the time of surgery through 24 month follow-up.

Additional Information

Samantha Andrews

Smith+Nephew, Inc.

Phone: 978.971.8990

Email: samantha.andrews@smith-nephew.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60