Post-market, Prospective Evaluation of Human Placental Membrane Tissue Used as an Adjunct for Foot and Ankle Tendon Surgery in Patients With Chronic Tendinopathy

NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery



Sponsors

Lead Sponsor



Source

CryoLife, Inc.

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

This study is a prospective, single center, postmarket study to evaluate the safety and
effectiveness of NeoPatch used as a tissue cover in foot and ankle tendon revision and repair
surgery.

Detailed Description

This study is a prospective, single center, postmarket study to evaluate the safety and
effectiveness of NeoPatch used as a tissue cover for chronically injured tendons requiring
surgical revision. NeoPatch is a tissue covering derived from terminally sterilized,
dehydrated human placental membrane tissue comprised of both amnion and chorion. Candidates
for this study are patients presenting with chronic tendon pain that are being evaluated for
primary tendon revision surgery following failure of standard of care or immediate need for
surgery, as determined by the investigator. Consented patients will receive NeoPatch as an
adjunct to their foot or ankle tendon revision; NeoPatch will be wrapped around the tendon
immediately prior to closure. The study will be divided into two phases: Screening and
Follow-up. The study will include prospective patient evaluations at scheduled clinic visits
and ultrasound appointments for a maximum of 12 visits over 12 months. Patient history,
medications, self-reported pain, tendon status, and adverse events will be collected on all
patients consented and enrolled into the study.

Overall Status

Recruiting

Start Date

2017-09-21

Completion Date

2019-03-01

Primary Completion Date

2019-03-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Quantitative ultrasound assessment of post-operative adhesions
Up to 3 weeks, post-op
Quantitative ultrasound assessment of post-operative adhesions
Up to 9 weeks, post-op
Quantitative ultrasound assessment of post-operative adhesions
Up to 15 weeks, post-op
Quantitative ultrasound assessment of post-operative adhesions
Up to 52 weeks, post-op
Change in quantitative ultrasound assessment of post-operative adhesions
Through study completion, an average of 1 year
Qualitative ultrasound assessment of post-operative adhesions
Up to 3 weeks, post-op
Qualitative ultrasound assessment of post-operative adhesions
Up to 9 weeks, post-op
Qualitative ultrasound assessment of post-operative adhesions
Up to 15 weeks, post-op
Qualitative ultrasound assessment of post-operative adhesions
Up to 52 weeks, post-op

Secondary Outcome

Measure

Time Frame

VAS Average Pain Score
Up to 1 year, post-op
VAS Current Pain Score
Up to 1 year, post-op
Change in VAS Average Pain Score
Through study completion, an average of 1 year
Change in VAS Current Pain Score
Through study completion, an average of 1 year
AOFAS Foot and Ankle Function Score
Up to 24 weeks, post-op
AOFAS Foot and Ankle Function Score
Up to 52 weeks, post-op
Change in AOFAS Foot and Ankle Function Score
Up to 24 weeks, post-op
Change in AOFAS Foot and Ankle Function Score
Up to 52 weeks, post-op
Use of Analgesics
Up to 52 weeks, post-op
Change in the Use of Analgesics
Through study completion, an average of 1 year

Enrollment

10

Conditions


Intervention

Intervention Type

Other

Intervention Name


Description

NeoPatch as an adjunct to foot and ankle tendon revision/repair surgery

Arm Group Label

Treatment


Eligibility

Criteria

Inclusion Criteria:

- Chronic tendinopathy requiring surgical revision in the opinion of the Investigator as
defined in Appendix G.

- Intention to schedule surgical revision.

≥ 18 years.

- Free from clinical signs of infection at time of screening and at time of surgical
intervention.

- Target tendon is one of the following: Achilles, Extensor Digitorum Longus, Extensor
Hallucis Brevis, Extensor Hallucis Longus, Flexor Digitorum Longus, Flexor Hallucis
Longus, Tibialis Anterior, Tibialis Posterior, Peroneus Longus, Peroneus Brevis,
Peroneus Tertius.

- Able and willing to provide consent and comply with protocol.

Exclusion Criteria:

- History of surgical intervention involving target tendon.

- Tendon injury is acute in nature.

- Current participation in another clinical study.

- Currently receiving radiation or chemotherapy.

- Diagnosis of autoimmune connective tissue disease requiring systemic immunomodulatory
therapy; stable NSAID doses for mild rheumatoid arthritis permitted.

- Use of biomedical growth factor within previous 30 days.

- Pregnant or breastfeeding or planning on becoming pregnant or unwilling to use
medically acceptable methods of birth control.

- Taking medications considered to be immune system modulators within previous 30 days.

- Patient taking specific Cox-2 inhibitors within previous 30 days.

- Currently being treated with an investigational device or drug (within 3 months prior
to surgery).

- Allergy, intolerance or hypersensitivity to any components or packaging of the
product.

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Douglas Pacaccio, DPM
Principal Investigator
Advanced Foot and Ankle Surgeons

Location

Facility

Status

Contact

Advanced Foot and Ankle Surgeons
Sycamore Illinois 60178 United States
Recruiting
Last Name: Douglas Pacaccio, DPM
Phone: 815-669-4811
Email: [email protected]

Location Countries

Country

United States


Verification Date

2017-10-01

Lastchanged Date

2017-10-10

Firstreceived Date

2017-09-12

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

1

Arm Group

Arm Group Label

Treatment

Arm Group Type

Experimental

Description

NeoPatch


Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Primary Purpose

Prevention

Masking

None (Open Label)


Study First Submitted

September 12, 2017

Study First Submitted Qc

October 10, 2017

Study First Posted

October 11, 2017

Last Update Submitted

October 10, 2017

Last Update Submitted Qc

October 10, 2017

Last Update Posted

October 11, 2017


ClinicalTrials.gov processed this data on October 11, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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