Efficacy of a Single Image Guided Injection of CTM for Gl... | NCT06171542

Studies
Efficacy of a Single Image Guided Injection of CTM for Glenohumeral Arthritis

NCT06171542

Sponsor

Indiana Hand to Shoulder Center

Status

Unknown status

Last Update Posted

Mar 27, 2024Actual

Enrollment

30Estimated

Phase

Phase 1

Conditions

Osteoarthritis Shoulder
Glenohumeral Osteoarthritis
Shoulder Osteoarthritis

Interventions

CTM Injection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 22, 2022Actual

Primary Completion Date

Apr 30, 2024Estimated

Completion Date

Apr 30, 2025Estimated

First Submitted Date

Dec 1, 2023

First Submission Date that Met QC Criteria

Dec 6, 2023

First Posted Date

Dec 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2024

Last Update Posted Date

Mar 27, 2024Actual

Name	Class
CTM Biomedical	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CTM Shoulder Injection	Experimental		Device: CTM Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CTM Injection	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Likert Pain Scale	PROM	12 Months
Oxford Shoulder Score	PROM	12 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indiana Hand to Shoulder Center		Indianapolis	Indiana	46260	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention 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.