TendinopathyNCT03307499
NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery
A study testing NeoPatch in people with Tendinopathy and Tendon Tear, run by CryoLife, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendinopathy, Tendon Tear, Tendon Injuries
- What is being tested?
- NeoPatch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 15 May 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Foot and Ankle Surgeons
Sycamore, Illinois, 60178
About this study
Official title: 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.
Read the 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.
- Conditions
- Tendinopathy, Tendon Tear, Tendon Injuries, Foot Ankle Injuries
- Being tested
- NeoPatch
- Medical subject headings
- Tendinopathy, Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoPatchOther
NeoPatch as an adjunct to foot and ankle tendon revision/repair surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | NeoPatch Receives: Other: NeoPatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative ultrasound assessment of post-operative adhesions
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Measured: Up to 3 weeks, post-op
Quantitative ultrasound assessment of post-operative adhesions
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Measured: Up to 9 weeks, post-op
Quantitative ultrasound assessment of post-operative adhesions
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Measured: Up to 15 weeks, post-op
Quantitative ultrasound assessment of post-operative adhesions
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Measured: Up to 52 weeks, post-op
Change in quantitative ultrasound assessment of post-operative adhesions
Average percent change in physical measurement of target tendon adhesions, by ultrasound assessment.
Measured: Through study completion, an average of 1 year
Qualitative ultrasound assessment of post-operative adhesions
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Measured: Up to 3 weeks, post-op
Qualitative ultrasound assessment of post-operative adhesions
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Measured: Up to 9 weeks, post-op
Qualitative ultrasound assessment of post-operative adhesions
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Measured: Up to 15 weeks, post-op
Qualitative ultrasound assessment of post-operative adhesions
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Measured: Up to 52 weeks, post-op
Secondary outcomes (10)
VAS Average Pain Score
Average self-reported pain experienced on average
Measured: Up to 1 year, post-op
VAS Current Pain Score
Average self-reported pain experienced at time of assessment (current)
Measured: Up to 1 year, post-op
Change in VAS Average Pain Score
Average change in self-reported average pain from baseline (screening) to last follow-up visit.
Measured: Through study completion, an average of 1 year
Change in VAS Current Pain Score
Average change in self-reported current pain from baseline (screening) to last follow-up visit.
Measured: Through study completion, an average of 1 year
AOFAS Foot and Ankle Function Score
Average AOFAS score
Measured: Up to 24 weeks, post-op
AOFAS Foot and Ankle Function Score
Average AOFAS score
Measured: Up to 52 weeks, post-op
Change in AOFAS Foot and Ankle Function Score
Average AOFAS score change between baseline (Screening) and Visit 7
Measured: Up to 24 weeks, post-op
Change in AOFAS Foot and Ankle Function Score
Average AOFAS score change between baseline (Screening) and Visit 8
Measured: Up to 52 weeks, post-op
Use of Analgesics
Percentage of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.
Measured: Up to 52 weeks, post-op
Change in the Use of Analgesics
Percent change of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start21 Sep 2017
- Primary completion31 Dec 2018
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- CryoLife, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas Pacaccio, DPM, Principal investigator, Advanced Foot and Ankle Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307499
- Sponsor's protocol ID
- HPM1701.000-M
- Status last verified
- May 2019
- First submitted
- 12 Sep 2017
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market, Prospective Evaluation of Human Placental Membrane Tissue Used as an Adjunct for Foot and Ankle Tendon Surgery in Patients With Chronic Tendinopathy
- ClinicalTrials.gov ID
- NCT03307499
- Acronym / sponsor ID
- HPM1701.000-M
- Conditions
- Tendinopathy, Tendon Tear, Tendon Injuries, Foot Ankle Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- CryoLife, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 11 Oct 2017 (actual)
- 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: NeoPatchNeoPatch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| NeoPatchNeoPatch as an adjunct to foot and ankle tendon revision/repair surgery | Other | Treatment |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
10 secondary outcomes
VAS Average Pain Score
Time frame: Up to 1 year, post-op
VAS Current Pain Score
Time frame: Up to 1 year, post-op
Change in VAS Average Pain Score
Time frame: Through study completion, an average of 1 year
Change in VAS Current Pain Score
Time frame: Through study completion, an average of 1 year
AOFAS Foot and Ankle Function Score
Time frame: Up to 24 weeks, post-op
AOFAS Foot and Ankle Function Score
Time frame: Up to 52 weeks, post-op
Change in AOFAS Foot and Ankle Function Score
Time frame: Up to 24 weeks, post-op
Change in AOFAS Foot and Ankle Function Score
Time frame: Up to 52 weeks, post-op
Use of Analgesics
Time frame: Up to 52 weeks, post-op
Change in the Use of Analgesics
Time frame: Through study completion, an average of 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 24 May 2019.
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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.
Douglas Pacaccio, DPM principal investigator
Advanced Foot and Ankle Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeoPatch in people with Tendinopathy and Tendon Tear, run by CryoLife, Inc. 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 6 inclusion and 11 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 24 May 2019. 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?
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?
Quantitative ultrasound assessment of post-operative adhesions (time frame: Up to 3 weeks, post-op). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2019.