NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery

May 23, 2019 updated by: CryoLife, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Sycamore, Illinois, United States, 60178
        • Advanced Foot and Ankle Surgeons

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
NeoPatch
Other: NeoPatch
NeoPatch as an adjunct to foot and ankle tendon revision/repair surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quantitative ultrasound assessment of post-operative adhesions
Time Frame: Up to 3 weeks, post-op
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Up to 3 weeks, post-op
Quantitative ultrasound assessment of post-operative adhesions
Time Frame: Up to 9 weeks, post-op
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Up to 9 weeks, post-op
Quantitative ultrasound assessment of post-operative adhesions
Time Frame: Up to 15 weeks, post-op
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Up to 15 weeks, post-op
Quantitative ultrasound assessment of post-operative adhesions
Time Frame: Up to 52 weeks, post-op
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Up to 52 weeks, post-op
Change in quantitative ultrasound assessment of post-operative adhesions
Time Frame: Through study completion, an average of 1 year
Average percent change in physical measurement of target tendon adhesions, by ultrasound assessment.
Through study completion, an average of 1 year
Qualitative ultrasound assessment of post-operative adhesions
Time Frame: Up to 3 weeks, post-op
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Up to 3 weeks, post-op
Qualitative ultrasound assessment of post-operative adhesions
Time Frame: Up to 9 weeks, post-op
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Up to 9 weeks, post-op
Qualitative ultrasound assessment of post-operative adhesions
Time Frame: Up to 15 weeks, post-op
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Up to 15 weeks, post-op
Qualitative ultrasound assessment of post-operative adhesions
Time Frame: Up to 52 weeks, post-op
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Up to 52 weeks, post-op

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
VAS Average Pain Score
Time Frame: Up to 1 year, post-op
Average self-reported pain experienced on average
Up to 1 year, post-op
VAS Current Pain Score
Time Frame: Up to 1 year, post-op
Average self-reported pain experienced at time of assessment (current)
Up to 1 year, post-op
Change in VAS Average Pain Score
Time Frame: Through study completion, an average of 1 year
Average change in self-reported average pain from baseline (screening) to last follow-up visit.
Through study completion, an average of 1 year
Change in VAS Current Pain Score
Time Frame: Through study completion, an average of 1 year
Average change in self-reported current pain from baseline (screening) to last follow-up visit.
Through study completion, an average of 1 year
AOFAS Foot and Ankle Function Score
Time Frame: Up to 24 weeks, post-op
Average AOFAS score
Up to 24 weeks, post-op
AOFAS Foot and Ankle Function Score
Time Frame: Up to 52 weeks, post-op
Average AOFAS score
Up to 52 weeks, post-op
Change in AOFAS Foot and Ankle Function Score
Time Frame: Up to 24 weeks, post-op
Average AOFAS score change between baseline (Screening) and Visit 7
Up to 24 weeks, post-op
Change in AOFAS Foot and Ankle Function Score
Time Frame: Up to 52 weeks, post-op
Average AOFAS score change between baseline (Screening) and Visit 8
Up to 52 weeks, post-op
Use of Analgesics
Time Frame: Up to 52 weeks, post-op
Percentage of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.
Up to 52 weeks, post-op
Change in the Use of Analgesics
Time Frame: Through study completion, an average of 1 year
Percent change of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CryoLife, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Douglas Pacaccio, DPM, Advanced Foot and Ankle Surgeons

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HPM1701.000-M

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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