Tendon InjuriesNCT03828916
NuShield in Surgical Peroneal Tendon Repair
A study testing NuShield in people with Tendon Injuries and Tendinopathy, run by NuTech Medical, Inc at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the use of NuShield in subjects requiring surgical tendon repair. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tendon Injuries, Tendinopathy
- What is being tested?
- NuShield
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jan 2019to Jun 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18 to 60 inclusive
- If female, actively practicing a medically relevant method of contraception, abstinent, surgically sterile, or post-menopausal (defined as no menses for at least 12 months)
- Have a diagnosis of one of the following in relation to the peroneal tendon:
- Tendonitis with MRI confirmation
- Synovial inflammation
- Tear
- Diagnosis resulting from acute injury to the tendon
Who cannot join
- BMI equal to or greater than 35
- Prior injury to the peroneal tendon
- Collagen disorders
- Inflammatory arteriopathies
- Immune compromised
- Diabetic
Show all 18Show fewer
- Less than 6 months between injury and proposed surgery date
- Steroid injection within the past 6 weeks localized to the treatment area
- Pregnant within the past six (6) months, breast feeding and/or desire to become pregnant during the course of the study, as verified by urine pregnancy test within one week prior to treatment
- History of more than two (2) weeks treatment with immuno-suppressants, including systemic corticosteroids or cytotoxic chemotherapy within one month prior to initial screening, or have received such medications during the screening period, or are anticipated to require such medications during the course of the study
- Taking any investigational drug(s) or therapeutic device(s) within 30 days preceding screening
- History of radiation therapy of the affected foot
- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
- Currently involved in medical litigation, including Worker's Compensation claims of any type
- Unable to understand the objectives of the trial
- Presence of any condition(s) which, in the opinion of the investigator, would compromise the subject's ability to complete this study
- Having a known history of poor adherence with medical treatment
- Express an unwillingness to receive human allograft tissue
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Health Orthopedics Clinic - Anschutz Medical Campus
Aurora, Colorado, 80045
720-848-1900
- Recruiting
Central Research Associates, Inc.
Birmingham, Alabama, 35205
Shannon Helton, RN, 205-327-1077, shannon@centraltrials.com
Norman Waldrop, M.D.
About this study
Official title: Single Arm Clinical Evaluation of the Safety and Efficacy of the NuShield® Allograft for Peroneal Tendon Repair
The purpose of this study is to evaluate the use of NuShield in subjects requiring surgical tendon repair.
Read the detailed description
The objective of this clinical trial is to evaluate both the safety and efficacy of using the NuShield® allograft in addition to standard of care surgical procedures in subjects requiring surgical repair of the peroneal tendon. The effects of this treatment will be assessed using:
- Questionnaires
- Visual Analog Scale Foot and Ankle (VAS FA)
- FAAM Sport
- PROMIS Global Health SF
- Tegner Activity Scale
- Foot and Ankle Outcomes Instrument (Q1, Q2)
- Swelling assessments
- Ultrasound imaging for tendon thickness, gliding and adhesion formation
- Conditions
- Tendon Injuries, Tendinopathy
- Being tested
- NuShield
- Keywords
- Tendon Surgery, NuShield
- Medical subject headings
- Tendon Injuries, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuShieldOther
SOC surgery with the addition of NuShield
| Study group | Role | What they receive |
|---|---|---|
| NuShield | Other | Not described Receives: Other: NuShield |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Foot and Ankle Pain
Visual Analogue Scale (VAS) foot and ankle pain. Change in pain intensity scores from baseline. VAS is measured in mm (scale 0-100); with 0 indicating worse outcomes and 100 indicating better outcome
Measured: 6 Months
FAAM Sports Subscale
Foot and Ankle Ability Measure (FAAM) Sports Subscale. Changes in FAAM Sport scores from baseline (scale 0-4); with 0 indicating better outcomes and 4 indicating worse outcomes
Measured: 6 Months
Secondary outcomes (5)
Adverse Events
Evaluations of safety will include serious adverse events or observed and/or volunteered adverse events.
Measured: up to 1 year
Swelling assessment by investigator
Circumferential measurement of the limbs. Change in swelling measured in cm
Measured: 6 and 12 months
PROMIS Global Health Subscale
PROMIS® (Patient-Reported Outcomes Measurement Information System) Global Health Subscale. Changes from baseline (scale 1-5); with 5 indicating better outcomes and 1 indicating worse outcomes
Measured: 6 and 12 months
Tegner Activity Scale
Tegner Activity Scale (scale 0-10). Changes from baseline; with 0 indicating worse outcomes and 10 indicating better outcomes
Measured: 6 and 12 months
Foot and Ankle Outcome Instrument, Questions 1 and 2 (subscale)
Patient reported outcome (PRO) measurement of stiffness and swelling (1-5); with 1 indicating better outcomes and 5 indicating worse outcomes
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start30 Jan 2019
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon InjuriesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuTech Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Organogenesis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828916
- Sponsor's protocol ID
- RD2018-01-01
- Status last verified
- Jan 2020
- First submitted
- 20 Jul 2018
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Clinical Evaluation of the Safety and Efficacy of the NuShield® Allograft for Peroneal Tendon Repair
- ClinicalTrials.gov ID
- NCT03828916
- Acronym / sponsor ID
- RD2018-01-01
- Conditions
- Tendon Injuries, Tendinopathy
- Keywords
- Tendon Surgery, NuShield
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NuTech Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- Organogenesis
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 4 Feb 2019 (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.
The purpose of this study is to evaluate the use of NuShield in subjects requiring surgical tendon repair.
Detailed description
The objective of this clinical trial is to evaluate both the safety and efficacy of using the NuShield® allograft in addition to standard of care surgical procedures in subjects requiring surgical repair of the peroneal tendon. The effects of this treatment will be assessed using:
- Questionnaires
- Visual Analog Scale Foot and Ankle (VAS FA)
- FAAM Sport
- PROMIS Global Health SF
- Tegner Activity Scale
- Foot and Ankle Outcomes Instrument (Q1, Q2)
- Swelling assessments
- Ultrasound imaging for tendon thickness, gliding and adhesion formation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NuShield | Other | Other: NuShield |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Ages 18 to 60 inclusive
- If female, actively practicing a medically relevant method of contraception, abstinent, surgically sterile, or post-menopausal (defined as no menses for at least 12 months)
- Have a diagnosis of one of the following in relation to the peroneal tendon:
- Diagnosis resulting from acute injury to the tendon
Key exclusion criteria (18 listed)
- BMI equal to or greater than 35
- Prior injury to the peroneal tendon
- Collagen disorders
- Inflammatory arteriopathies
- Immune compromised
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 |
|---|---|---|
| NuShieldSOC surgery with the addition of NuShield | Other | NuShield |
Primary outcome
VAS Foot and Ankle Pain
Time frame: 6 Months
Visual Analogue Scale (VAS) foot and ankle pain. Change in pain intensity scores from baseline. VAS is measured in mm (scale 0-100); with 0 indicating worse outcomes and 100 indicating better outcome
FAAM Sports Subscale
Time frame: 6 Months
Foot and Ankle Ability Measure (FAAM) Sports Subscale. Changes in FAAM Sport scores from baseline (scale 0-4); with 0 indicating better outcomes and 4 indicating worse outcomes
5 secondary outcomes
Adverse Events
Time frame: up to 1 year
Swelling assessment by investigator
Time frame: 6 and 12 months
PROMIS Global Health Subscale
Time frame: 6 and 12 months
Tegner Activity Scale
Time frame: 6 and 12 months
Foot and Ankle Outcome Instrument, Questions 1 and 2 (subscale)
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NuShield in people with Tendon Injuries and Tendinopathy, run by NuTech Medical, Inc at 2 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 7 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katie Mowry (205-800-8301, kmowry@organo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS Foot and Ankle Pain (time frame: 6 Months). The study lists 2 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 14 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.