Tendon TearsAmnioxNCT01708187

The Role of C-HAM in the Surgical Repair of Peroneal Tendons: An Infrared Thermography Model

A study testing Clarix™1k graft in people with Tendon Tears, run by Orthopedic Foot and Ankle Center, Ohio at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Tendon Tears
What is being tested?: Clarix™1k graft
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: Oct 2012to Nov 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients requiring surgical repair of the peroneal tendon
Patients who voluntarily consent to research participation
Patients over the age of 18

Who cannot join

Patients who display a high surgical risk as determined by the investigative surgeon
Previous surgical repair of the peroneal tendon less than 2 years prior to surgery
Peroneus brevis tears in zone 3 or 4 that may hinder recovery in the investigator's opinion
Patients with allergy or history of drug reactions to Ciprofloxacin or Amphotericin B
Patients who are pregnant or breast feeding.
Patients who have had a clinically diagnosed autoimmune disease

Show all 10Show fewer

Patients who are unwilling to restrict pre and postoperative anti-inflammatories with the exception of ecotrin 325 mg QD for DVT prophylaxis during the postoperative immobilization period
Patients with an active infection
Patients who have a medical history that would likely make the patient an unreliable research participant
Patients requiring surgical repair of the peroneus longus tendon

Trial locations and contacts

1 site in 1 country.

United States1 site

Orthopedic Foot and Ankle Center
Westerville, Ohio, 43082

Other trials in United States

About this study

Official title: The Role of Cryopreserved Human Amniotic Membrane in the Surgical Repair of Peroneal Tendons: An Infrared Thermography Model

Peroneal tendon tears are a common etiology encountered by foot and ankle surgeons. Like all flexor tendon repairs adhesions are one of the more common challenges after surgery. Peroneal tendon gliding is key to their function as effective plantar flexors and evertors of the hindfoot. Scarring and adhesion correlate directly with the amount of inflammatory reaction at the wound site (Adzick 1994). Our goal is to have a surgical technique that allows for standard suture repair of the tendon yet allows for smooth gliding of the tendon with minimal adhesions. A prospective review on the surgical repair of the peroneal tendons utilizing Clarix™1k (Amniox Medical, Marietta, GA), cryopreserved Human Amniotic Membrane (C-HAM) graft will be performed. The investigators hypothesize that the use of cryopreserved Human Amniotic Membrane in conjunction with a peroneal tendon repair will decrease that amount of inflammation, overall recovery time of surgically repaired peroneal tendon tears, and adhesions.

Conditions: Tendon Tears
Being tested: Clarix™1k graft
Keywords: Peroneal tendon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clarix™1k graftBiological
Also called cryopreserved Human Amniotic Membrane (C-HAM) graft
Group 1 will have standard peroneal repair surgery with the addition of the Clarix™1k tissue.
Group 2 will have standard peroneal repair surgery without the use of the Clarix™1k tissue.

Study groups in NCT01708187
Study group	Role	What they receive
Clarix™1k graft	Experimental	Group 1 will have standard peroneal repair surgery with the addition of the Clarix™1k tissue. Receives: Biological: Clarix™1k graft
Control arm without Clarix™1k graft	No intervention	Group 2 will have standard peroneal repair surgery without the use of the Clarix™1k tissue.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months
Ankle pain measured via visual analog scale (VAS), function measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot scale and Foot Function Index (FFI), activity limitation measured by AOFAS scale. Images taken via thermal camera to measure inflammation were not interpretable.
VAS pain scale: 0-100, with a lower number representing a better score FFI scale: 0-100, with a lower number representing a better score AOFAS scale: 0-100, with a higher number representing a better score
Measured: Baseline,12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Nov 2014

First posted16 Oct 2012 (estimated)
Study startOct 2012
Primary completionNov 2014
Study completionNov 2014

Why it stopped: Protocol halted due to less than anticipated recruitment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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: Outcomes assessor
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01708187
Sponsor's protocol ID: OH1-12-00396
Acronym: Amniox
Status last verified: Sep 2016
First submitted: 5 Sep 2012
Last updated: 3 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tendon Tears trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Cryopreserved Human Amniotic Membrane in the Surgical Repair of Peroneal Tendons: An Infrared Thermography Model
ClinicalTrials.gov ID: NCT01708187
Acronym / sponsor ID: Amniox / OH1-12-00396
Conditions: Tendon Tears
Keywords: Peroneal tendon
Study type: Interventional
Recruitment status: TerminatedReason stopped: Protocol halted due to less than anticipated recruitment.
Enrolment: 2 participants (actual)
Lead sponsor: Orthopedic Foot and Ankle Center, OhioUniversity, hospital or other
Study start: Oct 2012
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 16 Oct 2012 (estimated)
Results: Posted 19 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Clarix™1k graft	Experimental	Biological: Clarix™1k graftGroup 1 will have standard peroneal repair surgery with the addition of the Clarix™1k tissue.
Control arm without Clarix™1k graft	No intervention	–Group 2 will have standard peroneal repair surgery without the use of the Clarix™1k tissue.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients requiring surgical repair of the peroneal tendon
Patients who voluntarily consent to research participation
Patients over the age of 18

Key exclusion criteria (10 listed)

Patients who display a high surgical risk as determined by the investigative surgeon
Previous surgical repair of the peroneal tendon less than 2 years prior to surgery
Peroneus brevis tears in zone 3 or 4 that may hinder recovery in the investigator's opinion
Patients with allergy or history of drug reactions to Ciprofloxacin or Amphotericin B
Patients who are pregnant or breast feeding.

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™1k graftAlso: cryopreserved Human Amniotic Membrane (C-HAM) graftGroup 1 will have standard peroneal repair surgery with the addition of the Clarix™1k tissue. Group 2 will have standard peroneal repair surgery without the use of the Clarix™1k tissue.	Biological	Clarix™1k graft

Primary outcome

Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months
Time frame: Baseline,12 months
Ankle pain measured via visual analog scale (VAS), function measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot scale and Foot Function Index (FFI), activity limitation measured by AOFAS scale. Images taken via thermal camera to measure inflammation were not interpretable. VAS pain scale: 0-100, with a lower number representing a better score FFI scale: 0-100, with a lower number representing a better score AOFAS scale: 0-100, with a higher number representing a better score

Results and safety

Results posted to the registry on 19 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clarix™1k Graft	1	1
Control Arm Without Clarix™1k Graft	1	0

Primary outcome: Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months

Time frame: Baseline,12 months. Number. Unit: units on a scale

Measure	Clarix™1k Graft n = 1	Control Arm Without Clarix™1k Graft n = 0
VAS pain at Baseline	66	–
VAS pain at 12 months	0	–
Change in VAS pain from Baseline to 12 months	-66	–
FFI at Baseline	61.76	–
FFI at 12 months	4.71	–
Change in FFI from Baseline to 12 months	-57.05	–
AOFAS at Baseline	70	–
AOFAS at 12 months	90	–

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clarix™1k Graft	0 of 1 (0%)	1 of 1 (100%)	Not reported
Control Arm Without Clarix™1k Graft	0 of 1 (0%)	0 of 1 (0%)	Not reported

Limitations and caveats (from the sponsor): Early termination leading to only one subject completing the trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
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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.

Gregory C Berlet, MD principal investigator

Orthopedic Foot and Ankle Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Clarix™1k graft in people with Tendon Tears, run by Orthopedic Foot and Ankle Center, Ohio at 1 site 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 10 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: stopped early, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 19 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months (time frame: Baseline,12 months). 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 NCT01708187.

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 3 Nov 2016.