Peroneal and Achilles Tendon TearsPATRICCNCT02719288
Peroneal and Achilles Tendon Repair Indications With CLARIX® CORD 1K
A study testing CLARIX® CORD 1K graft in people with Peroneal and Achilles Tendon Tears, run by Amniox Medical, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peroneal and Achilles Tendon Tears
- What is being tested?
- CLARIX® CORD 1K graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Feb 2016to 18 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
Banner Estrella Medical Center
Phoenix, Arizona, 85037
Banner Del Webb Medical Center
Sun City West, Arizona, 85375
Orthopedic Foot and Ankle Center
Westerville, Ohio, 43082
About this study
Official title: A Multi-center, Open Label, Economic Outcome Study Comparing the Recovery of Patients Receiving CLARIX® CORD 1K as an add-on Treatment During Surgical Tendon Repair to Control Patients Receiving Standard of Care Procedures
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
- Being tested
- CLARIX® CORD 1K graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLARIX® CORD 1K graftOther
| Study group | Role | What they receive |
|---|---|---|
| CLARIX® CORD 1K | Experimental | Applied in addition to standard of care tendon repair surgery. Receives: Other: CLARIX® CORD 1K graft |
| Standard of care tendon repair surgery only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in patient questionnaire describing function limitation (American Orthopaedic Foot and Ankle Society ankle hindfoot score).
Measured: Baseline and 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study start15 Feb 2016
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peroneal and Achilles Tendon TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amniox Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scheffer Tseng, MD, PhD, Study chair, BioTissue Holdings, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719288
- Sponsor's protocol ID
- CR-2010
- Acronym
- PATRICC
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2016
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gelberman RH, Manske PR. Factors influencing flexor tendon adhesions. Hand Clin. 1985 Feb;1(1):35-42.
PubMed 4093463Adzick 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.
PubMed 8024353Jaibaji 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.
PubMed 10917106Liu 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.
PubMed 21436959Swift H. Amnion for leg ulcers. Lancet. 1980 Jun 21;1(8182):1366-7. doi: 10.1016/s0140-6736(80)91819-x. No abstract available.
PubMed 6104165Dua 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.
PubMed 14711440Bouchard 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.
PubMed 17216092
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open Label, Economic Outcome Study Comparing the Recovery of Patients Receiving CLARIX® CORD 1K as an add-on Treatment During Surgical Tendon Repair to Control Patients Receiving Standard of Care Procedures
- ClinicalTrials.gov ID
- NCT02719288
- Acronym / sponsor ID
- PATRICC / CR-2010
- Conditions
- Peroneal and Achilles Tendon Tears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Amniox Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLARIX® CORD 1K | Experimental | Other: CLARIX® CORD 1K graftApplied in addition to standard of care tendon repair surgery. |
| Standard of care tendon repair surgery only | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLARIX® CORD 1K graft | Other | CLARIX® CORD 1K |
Primary outcome
Change from baseline in patient questionnaire describing function limitation (American Orthopaedic Foot and Ankle Society ankle hindfoot score).
Time frame: Baseline and 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Background: PubMed 4093463Gelberman RH, Manske PR. Factors influencing flexor tendon adhesions. Hand Clin. 1985 Feb;1(1):35-42.
- Background: PubMed 8024353Adzick 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.
- Background: PubMed 10917106Jaibaji 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.
- Background: PubMed 21436959Liu 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.
- Background: PubMed 6104165Swift H. Amnion for leg ulcers. Lancet. 1980 Jun 21;1(8182):1366-7. doi: 10.1016/s0140-6736(80)91819-x. No abstract available.
- Background: PubMed 14711440Dua 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.
- Background: PubMed 17216092Bouchard 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scheffer Tseng, MD, PhD study chair
BioTissue Holdings, Inc
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLARIX® CORD 1K graft in people with Peroneal and Achilles Tendon Tears, run by Amniox Medical, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in patient questionnaire describing function limitation (American Orthopaedic Foot and Ankle Society ankle hindfoot score). (time frame: Baseline and 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02719288, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.