Shoulder InjuryNCT03084068
Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair
A study testing Human dehydrated umbilical cord allograft in people with Shoulder Injury and Shoulder Sprain, run by MiMedx Group, Inc. at 1 site in United States.
Trial summary
To determine the effectiveness of human dehydrated umbilical cord allograft in standard open rotator cuff repair as assessed by the American Shoulder and Elbow Surgeons (ASES) score 12 months post-op. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Injury, Shoulder Sprain, Supraspinatus Tear
- What is being tested?
- Human dehydrated umbilical cord allograft
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 17 Jan 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
- MRI confirmed diagnosis of a full thickness supraspinatus tendon tear necessitating surgical intervention (rotator cuff repair)
- Subject is male or female age 18 or older
- Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
Who cannot join
- Subjects who meet ANY of the following criteria will be excluded from the study:
- Shoulder pain primarily attributed to any of the following:
- Ligament rupture due to use of fluoroquinolones
- Capsular tear
- Fracture of the humeral head
- Inflammation of the joint or surrounding tissue (i.e. osteoarthritis, bursitis)
Show all 20Show fewer
- Neuropathic, radiating pain from conditions resulting in damage or inflammation of the nerve
- Previous history of autoimmune connective tissue disorders (i.e. rheumatoid arthritis, systemic lupus erythematosus)
- Known history of poor compliance with medical treatments
- Subject has bilateral supraspinatus tendon tear
- Subject has signs and symptoms of an active infection of the shoulder joint
- Retraction of the supraspinatus tendon exceeding 1.5 cm in length
- Subject has additional injuries requiring further surgical intervention to the ipsilateral arm
- Subject has had previous surgery in the target arm within the past 6 months prior to treatment or plans to have surgery other than Rotator Cuff Repair in the target arm within 180 days of treatment
- Subjects currently receiving radiation therapy or chemotherapy
- Subjects has used an investigational drug, device or biologic within 12 weeks prior to treatment
- Subjects who are pregnant at enrollment or are planning to become pregnant within 180 days of treatment
- Subject has any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
- Allergy or known sensitivity to aminoglycoside antibiotics such as gentamicin sulfate and/or streptomycin sulfate
- Workers' compensation patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized Controlled Trial for Rotator Cuff Repair - Efficacy of Supraspinatus Tendon Repair Using a Human Dehydrated Umbilical Cord Patch
To determine the effectiveness of human dehydrated umbilical cord allograft in standard open rotator cuff repair as assessed by the American Shoulder and Elbow Surgeons (ASES) score 12 months post-op.
- Conditions
- Shoulder Injury, Shoulder Sprain, Supraspinatus Tear
- Being tested
- Human dehydrated umbilical cord allograft, Placebo
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human dehydrated umbilical cord allograftOther
human dehydrated umbilical cord allograft
PlaceboOther
Open rotator cuff surgery with standard suture repair
| Study group | Role | What they receive |
|---|---|---|
| Human umbilical cord allograft | Experimental | Open Rotator Cuff Repair patched with human dehydrated umbilical cord allograft Receives: Other: Human dehydrated umbilical cord allograft |
| Placebo Control | Placebo comparator | Open Rotator Cuff Repair with standard suture repair Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASES score
The primary endpoint of the study is the number of subjects achieving a 20% increase from baseline in the overall ASES score at 12 months post-op.
Measured: 12 months
Secondary outcomes (5)
Constant Murley Score
Comparison of Constant scores between the two groups at each study time point
Measured: 12 months
Shoulder range of motion
Assessment of the change in the range of motion of the shoulder joint for both treatment groups at each study time point.
Measured: 12 months
VAS Pain scores
Change in patient reported pain from baseline
Measured: 12 months
Incidence of tendon re-tear
Incidence of supraspinatus tendon re-tear in the two treatment groups as assessed by review of MRI scans by independent radiologists
Measured: 12 months
Incidence of adverse events
Incidence of adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start1 Feb 2017
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InjuryStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Mason, MD, Study director, MiMedx Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084068
- Sponsor's protocol ID
- ACORT001
- Status last verified
- Dec 2019
- First submitted
- 14 Mar 2017
- Last updated
- 18 Dec 2019
- 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 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Trial for Rotator Cuff Repair - Efficacy of Supraspinatus Tendon Repair Using a Human Dehydrated Umbilical Cord Patch
- ClinicalTrials.gov ID
- NCT03084068
- Acronym / sponsor ID
- ACORT001
- Conditions
- Shoulder Injury, Shoulder Sprain, Supraspinatus Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 20 Mar 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.
To determine the effectiveness of human dehydrated umbilical cord allograft in standard open rotator cuff repair as assessed by the American Shoulder and Elbow Surgeons (ASES) score 12 months post-op.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human umbilical cord allograft | Experimental | Other: Human dehydrated umbilical cord allograftOpen Rotator Cuff Repair patched with human dehydrated umbilical cord allograft |
| Placebo Control | Placebo comparator | Other: PlaceboOpen Rotator Cuff Repair with standard suture repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MRI confirmed diagnosis of a full thickness supraspinatus tendon tear necessitating surgical intervention (rotator cuff repair)
- Subject is male or female age 18 or older
- Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
Key exclusion criteria (20 listed)
- Shoulder pain primarily attributed to any of the following:
- Known history of poor compliance with medical treatments
- Subject has bilateral supraspinatus tendon tear
- Subject has signs and symptoms of an active infection of the shoulder joint
- Retraction of the supraspinatus tendon exceeding 1.5 cm in length
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 |
|---|---|---|
| Human dehydrated umbilical cord allografthuman dehydrated umbilical cord allograft | Other | Human umbilical cord allograft |
| PlaceboOpen rotator cuff surgery with standard suture repair | Other | Placebo Control |
Primary outcome
ASES score
Time frame: 12 months
The primary endpoint of the study is the number of subjects achieving a 20% increase from baseline in the overall ASES score at 12 months post-op.
5 secondary outcomes
Constant Murley Score
Time frame: 12 months
Shoulder range of motion
Time frame: 12 months
VAS Pain scores
Time frame: 12 months
Incidence of tendon re-tear
Time frame: 12 months
Incidence of adverse events
Time frame: 12 months
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 18 Dec 2019.
- 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.
David Mason, MD study director
MiMedx Group, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human dehydrated umbilical cord allograft in people with Shoulder Injury and Shoulder Sprain, run by MiMedx Group, 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 3 inclusion and 20 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 18 Dec 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. Some participants in this study may receive a placebo. 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?
ASES score (time frame: 12 months). 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 18 Dec 2019.