Osteoarthritis ShoulderPhase 1HC22-1NCT06171542
Efficacy of a Single Image Guided Injection of CTM for Glenohumeral Arthritis
A Phase 1 study testing CTM Injection in people with Osteoarthritis Shoulder and Glenohumeral Osteoarthritis, run by Indiana Hand to Shoulder Center at 1 site in United States.
Trial summary
CTM Biomedical markets and distributes decellularized particulate human placental connective-tissue matrix products, intended solely for homologous use to supplement or replace damaged or inadequate connective-tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Shoulder, Glenohumeral Osteoarthritis, Shoulder Osteoarthritis
- What is being tested?
- CTM Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2022to 30 Apr 2025
- Phase
- Phase 1
- 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
- Radiographic documented Glenohumeral osteoarthritis (grade 1-3)
- Males or females age 18 or older
- Patients receiving a CTM injection for their initial treatment
- Patients who can consent to be a part of this study
- Patients who are able keep up regular communication through phone calls or electronic PROs
Who cannot join
- Inflammatory Arthritis
- Brachial Plexopathy
- Cervical spine abnormalities such as radiculopathies
- age less than 18 years
- those unable to keep up monthly communication through phone calls and/or electronic PROs
- Absence of glenohumeral osteoarthritis
- Pregnancy or breastfeeding
- Non-english speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260
About this study
Official title: Efficacy of a Single Image Guided Injection of Connective Tissue Matrix for Glenohumeral Arthritis
CTM Biomedical markets and distributes decellularized particulate human placental connective-tissue matrix products, intended solely for homologous use to supplement or replace damaged or inadequate connective-tissue. These are structural tissue allografts processed according to the criteria contained in 21CFR 1271.10(a) for regulation solely under section 361 of the Public Health Service Act.
The goal of this study is to determine the success rate of a single, image guided glenohumeral CTM injection (for radiographically confirmed glenohumeral osteoarthritis at follow up intervals of 1, 2, 3, 4, 6, 9, and 12 months. This will be measured using the Likert Pain Scale (LPS) and Oxford Shoulder Score (OSS). Secondary goals are to identify if certain demographic or imaging factors exist that predict early symptom recurrence requiring additional intervention, defined as a second connective tissue matrix injection, a subsequent corticosteroid injection, or arthroplasty.
Read the detailed description
A recent prospective study by our center identified a clinically meaningful and statistical improvement after corticosteroid injection in the Oxford Shoulder Score and VAS pain scores in patients with glenohumeral arthritis2.
CTM Biomedical markets and distributes decellularized particulate human placental connective-tissue matrix products, intended solely for homologous use to supplement or replace damaged or inadequate connective-tissue. These are structural tissue allografts processed according to the criteria contained in 21CFR 1271.10(a) for regulation solely under section 361 of the Public Health Service Act. CTM Flow is decellularized particulate human placental connective-tissue matrix provided in a vial.
Osteoarthritis creates pain due to damaged tissues. CTM has been approved to supplement and replace damaged tissues. It is not replacing the damaged cartilage with new cartilage, but rather with other connective tissues. Previous unpublished studies in tonsil surgery and knee arthritis surgery have shown improvement from the CTM injections.
Image guided injection of the glenohumeral joint has been shown to be more accurate than blind in-office injections and will thus be used in this study3.
The goal of this study is to determine the success rate of a single, image guided glenohumeral (GH) CTM injection (for radiographically confirmed glenohumeral osteoarthritis at follow up intervals of 1, 2, 3, 4, 6, 9, and 12 months. This will be measured using the Likert Pain Scale (LPS) and Oxford Shoulder Score (OSS). Secondary goals are to identify if certain demographic or imaging factors exist that predict early symptom recurrence requiring additional intervention, defined as a second connective tissue matrix injection, a subsequent corticosteroid injection, or arthroplasty.
- Being tested
- CTM Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTM InjectionDevice
All glenohumeral joint injections will be performed by a physician under the guidance of either ultrasound or fluoroscopy to ensure and document intra-articular needle placement. 2cc of CTM Flow will be injected. The glenohumeral joint will be injected with the medication under the discretion of the treating surgeon.
| Study group | Role | What they receive |
|---|---|---|
| CTM Shoulder Injection | Experimental | Not described Receives: Device: CTM Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likert Pain Scale
PROM
Measured: 12 Months
Oxford Shoulder Score
PROM
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 posted14 Dec 2023
- Study start22 Dec 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ShoulderStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All glenohumeral joint injections will be performed by a physician under the guidance of either ultrasound or fluoroscopy to ensure and document intra-articular needle placement. 2cc of CTM Flow will be injected. The glenohumeral joint will be injected with the medication under the discretion of the treating surgeon.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana Hand to Shoulder Center
- Sponsor type
- University, hospital or other
- Collaborators
- CTM Biomedical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171542
- Sponsor's protocol ID
- IHTSC CTM Project HC22-2
- Acronym
- HC22-1
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Single Image Guided Injection of Connective Tissue Matrix for Glenohumeral Arthritis
- ClinicalTrials.gov ID
- NCT06171542
- Acronym / sponsor ID
- HC22-1 / IHTSC CTM Project HC22-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Indiana Hand to Shoulder CenterUniversity, hospital or other
- Collaborators
- CTM Biomedical
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 14 Dec 2023 (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.
CTM Biomedical markets and distributes decellularized particulate human placental connective-tissue matrix products, intended solely for homologous use to supplement or replace damaged or inadequate connective-tissue. These are structural tissue allografts processed according to the criteria contained in 21CFR 1271.10(a) for regulation solely under section 361 of the Public Health Service Act.
The goal of this study is to determine the success rate of a single, image guided glenohumeral CTM injection (for radiographically confirmed glenohumeral osteoarthritis at follow up intervals of 1, 2, 3, 4, 6, 9, and 12 months. This will be measured using the Likert Pain Scale (LPS) and Oxford Shoulder Score (OSS). Secondary goals are to identify if certain demographic or imaging factors exist that predict early symptom recurrence requiring additional intervention, defined as a second connective tissue matrix injection, a subsequent corticosteroid injection, or arthroplasty.
Detailed description
A recent prospective study by our center identified a clinically meaningful and statistical improvement after corticosteroid injection in the Oxford Shoulder Score and VAS pain scores in patients with glenohumeral arthritis2.
CTM Biomedical markets and distributes decellularized particulate human placental connective-tissue matrix products, intended solely for homologous use to supplement or replace damaged or inadequate connective-tissue. These are structural tissue allografts processed according to the criteria contained in 21CFR 1271.10(a) for regulation solely under section 361 of the Public Health Service Act. CTM Flow is decellularized particulate human placental connective-tissue matrix provided in a vial.
Osteoarthritis creates pain due to damaged tissues. CTM has been approved to supplement and replace damaged tissues. It is not replacing the damaged cartilage with new cartilage, but rather with other connective tissues. Previous unpublished studies in tonsil surgery and knee arthritis surgery have shown improvement from the CTM injections.
Image guided injection of the glenohumeral joint has been shown to be more accurate than blind in-office injections and will thus be used in this study3.
The goal of this study is to determine the success rate of a single, image guided glenohumeral (GH) CTM injection (for radiographically confirmed glenohumeral osteoarthritis at follow up intervals of 1, 2, 3, 4, 6, 9, and 12 months. This will be measured using the Likert Pain Scale (LPS) and Oxford Shoulder Score (OSS). Secondary goals are to identify if certain demographic or imaging factors exist that predict early symptom recurrence requiring additional intervention, defined as a second connective tissue matrix injection, a subsequent corticosteroid injection, or arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All glenohumeral joint injections will be performed by a physician under the guidance of either ultrasound or fluoroscopy to ensure and document intra-articular needle placement. 2cc of CTM Flow will be injected. The glenohumeral joint will be injected with the medication under the discretion of the treating surgeon.
| Arm | Type | Receives |
|---|---|---|
| CTM Shoulder Injection | Experimental | Device: CTM Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Radiographic documented Glenohumeral osteoarthritis (grade 1-3)
- Males or females age 18 or older
- Patients receiving a CTM injection for their initial treatment
- Patients who can consent to be a part of this study
- Patients who are able keep up regular communication through phone calls or electronic PROs
Key exclusion criteria (8 listed)
- Inflammatory Arthritis
- Brachial Plexopathy
- Cervical spine abnormalities such as radiculopathies
- age less than 18 years
- those unable to keep up monthly communication through phone calls and/or electronic PROs
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 |
|---|---|---|
| CTM InjectionAll glenohumeral joint injections will be performed by a physician under the guidance of either ultrasound or fluoroscopy to ensure and document intra-articular needle placement. 2cc of CTM Flow will be injected. The glenohumeral joint will be injected with the medication under the discretion of the treating surgeon. | Device | CTM Shoulder Injection |
Primary outcome
Likert Pain Scale
Time frame: 12 Months
PROM
Oxford Shoulder Score
Time frame: 12 Months
PROM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTM Injection in people with Osteoarthritis Shoulder and Glenohumeral Osteoarthritis, run by Indiana Hand to Shoulder Center 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 5 inclusion and 8 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 27 Mar 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Likert Pain Scale (time frame: 12 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 27 Mar 2024.