Peroneal and Achilles Tendon Repair Indications With CLAR... | NCT02719288

Studies
Peroneal and Achilles Tendon Repair Indications With CLARIX® CORD 1K

NCT02719288

Sponsor

Amniox Medical, Inc.

Status

Completed

Last Update Posted

Mar 31, 2020Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Peroneal and Achilles Tendon Tears

Interventions

CLARIX® CORD 1K graft

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2016Actual

Primary Completion Date

Dec 18, 2018Actual

Completion Date

Dec 18, 2018Actual

First Submitted Date

Mar 17, 2016

First Submission Date that Met QC Criteria

Mar 21, 2016

First Posted Date

Mar 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2020

Last Update Posted Date

Mar 31, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Peroneal and Achilles tendon tears are common diseases that present challenges to surgeons due to tendon adhesion complications. Functional recovery is compromised by limiting post-operative range of motion, mobility, and can lead to considerable amount of post-operative pain for the patient.

Amniotic membrane tissue has demonstrated clinical success as an anti-inflammatory and anti-scarring agent and promoting wound healing towards regeneration.

Cryopreserved human amniotic membrane and umbilical cord (AM/UC) tissue in the form of CLARIX® CORD 1K has been used to treat over 5000 orthopedic patients. The investigators hypothesize that its use in peroneal and Achilles tendon surgical repair will enhance the overall functional recovery of the patient.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CLARIX® CORD 1K	Experimental	Applied in addition to standard of care tendon repair surgery.	Other: CLARIX® CORD 1K graft
Standard of care tendon repair surgery only	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CLARIX® CORD 1K graft	Other		CLARIX® CORD 1K

Measure	Description	Time Frame
Change from baseline in patient questionnaire describing function limitation (American Orthopaedic Foot and Ankle Society ankle hindfoot score).		Baseline and 1 Year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female patients 18 years to 80 years of age
Confirmed tendon pathology via MRI, if clinically necessary, with planned surgical repair that have failed conservative management (PT) for a minimum of 2 months for chronic and partial thickness tears; acute full thickness tears or tendon rupture immediately eligible.
Willing to follow the instructions and complete the visits required.

Exclusion Criteria:

Psychologically unstable
Acute infections that, in the opinion of the investigator, may complicate healing
Currently receiving chemotherapy
Systemic inflammatory arthritis or Rheumatoid arthritis
Uncontrolled diabetes as measured by A1C>12
Bleeding disorders
Unable to provide informed consent
Has received oral or parenteral corticosteroids or cytotoxic agents for seven consecutive days in the period of 30 days before surgery OR has received a local steroid injection within 7 days of surgery
Immunocompromised patients
Active malignancy other than non-melanoma skin cancer
Untreated alcohol or substance abuse issues at the time of screening
Pregnant women at the time of randomization
Currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening
Allergy to amphotericin-B or Dulbecco's Modified Eagle Medium (DMEM).
Will undergo significant concurrent procedures with the tendon procedures on the affected foot that, in the opinion of the Investigator, may complicate healing or alter the post-operative visit schedule

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Scheffer Tseng, MD, PhD	BioTissue Holdings, Inc	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Banner Estrella Medical Center		Phoenix	Arizona	85037	United States
Banner Del Webb Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
4093463	Background	Gelberman RH, Manske PR. Factors influencing flexor tendon adhesions. Hand Clin. 1985 Feb;1(1):35-42.
8024353	Background	Adzick NS, Lorenz HP. Cells, matrix, growth factors, and the surgeon. The biology of scarless fetal wound repair. Ann Surg. 1994 Jul;220(1):10-8. doi: 10.1097/00000658-199407000-00003.