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

NCT02719288 | Completed

• 1 other identifier: CR-2010
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 4

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.

Conditions

Peroneal and Achilles Tendon Tears

Outcome Measures

Primary Outcomes (1)

• Change from baseline in patient questionnaire describing function limitation (American Orthopaedic Foot and Ankle Society ankle hindfoot score).

  Baseline and 1 Year

Study Arms (2)

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

CLARIX® CORD 1K graft OTHER

CLARIX® CORD 1K

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Amniox Medical, Inc.: lead

Study Sites (4)

Banner Estrella Medical Center

Phoenix, Arizona, 85037, United States

Location

Banner Del Webb Medical Center

Sun City West, Arizona, 85375, United States

Location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Orthopedic Foot and Ankle Center

Westerville, Ohio, 43082, United States

Location

Related Publications (7)

• Gelberman RH, Manske PR. Factors influencing flexor tendon adhesions. Hand Clin. 1985 Feb;1(1):35-42.

  PMID: 4093463 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.

  PMID: 8024353 BACKGROUND

• Jaibaji M. Advances in the biology of zone II flexor tendon healing and adhesion formation. Ann Plast Surg. 2000 Jul;45(1):83-92. doi: 10.1097/00000637-200045010-00017.

  PMID: 10917106 BACKGROUND

• Liu J, Sheha H, Fu Y, Liang L, Tseng SC. Update on amniotic membrane transplantation. Expert Rev Ophthalmol. 2010 Oct;5(5):645-661. doi: 10.1586/eop.10.63.

  PMID: 21436959 BACKGROUND

• Swift H. Amnion for leg ulcers. Lancet. 1980 Jun 21;1(8182):1366-7. doi: 10.1016/s0140-6736(80)91819-x. No abstract available.

  PMID: 6104165 BACKGROUND

• Dua HS, Gomes JA, King AJ, Maharajan VS. The amniotic membrane in ophthalmology. Surv Ophthalmol. 2004 Jan-Feb;49(1):51-77. doi: 10.1016/j.survophthal.2003.10.004.

  PMID: 14711440 BACKGROUND

• Bouchard CS, John T. Amniotic membrane transplantation in the management of severe ocular surface disease: indications and outcomes. Ocul Surf. 2004 Jul;2(3):201-11. doi: 10.1016/s1542-0124(12)70062-9.

  PMID: 17216092 BACKGROUND

Study Officials

• Scheffer Tseng, MD, PhD

  BioTissue Holdings, Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 25, 2016
• Study Start: February 15, 2016
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)