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Corticosteroid

Test CTM Injection for Tennis Elbow

Phase 2

Waitlist Available

Research Sponsored by Indiana Hand to Shoulder Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who have not had a meaningful symptomatic improvement after 6 weeks of physical therapy

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial aims to test a single application of human placenta-derived tissue as a treatment for a connective tissue disorder. It must be handled and administered according to FDA regulations.

Who is the study for?

This trial is for individuals suffering from Tennis Elbow, a type of tendinopathy. Specific eligibility criteria are not provided, but typically participants would need to have symptoms consistent with Tennis Elbow and be suitable candidates for the treatments being tested.Check my eligibility

What is being tested?

The study aims to assess the effectiveness of a single application of CTM's human Connective Tissue Allograft (CTA) compared to Celestone in treating Tennis Elbow. The CTA involves using processed human placental tissue intended to repair or replace damaged connective tissue.See study design

What are the potential side effects?

Potential side effects are not detailed in the information provided. However, as with any medical intervention, there could be risks associated with the procedure and materials used which should be discussed with healthcare providers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I haven't felt better after 6 weeks of physical therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient-Related Tennis Elbow Evaluation (PRTEE) Pain Subscale

Secondary outcome measures

Grip Strength

PROMIS Depression

PROMIS Pain Interference

+2 more

Side effects data

From 2015 Phase 4 trial • 400 Patients • NCT01238536

22%

All other self reported adverse events

Hospitalization or Surgery

Dural puncture

100%

80%

60%

40%

20%

Study treatment Arm

Epidural Steroid Injection

Epidural Local Anesthetic Injection

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Test CTM InjectionExperimental Treatment1 Intervention

Group 2 Test Group: CTM injection: 1cc of CTM Boost will be diluted with 1 cc of 1% lidocaine and injected at the ECRB origin at area of maximal pain when palpated. CTM Boost is a connective tissue matrix suspended in saline. (injection will need to be with a 23 gauge needle and 3 cc syringe)

Group II: Standard of Care Steroid InjectionActive Control1 Intervention

Group 1 Control Group: standard corticosteroid injection: 1cc of celestone (6mg) diluted with 1 cc of 1% lidocaine and inject at the ECRB origin at area of maximal pain when palpated.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana Hand to Shoulder CenterLead Sponsor

8 Previous Clinical Trials

296 Total Patients Enrolled

CTM BiomedicalIndustry Sponsor

3 Previous Clinical Trials

95 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum participant capacity of this clinical investigation?

"Affirmative. Clinicaltrials.gov attests that this clinical trial is currently recruiting volunteers, with an initial posting date of January 26th 2023 and a recent update on December 6th 2023. The study requires 54 participants from one site."

Answered by AI

Are there any vacancies open for individuals wishing to participate in this clinical trial?

"Affirmative. Clinicaltrials.gov provides evidence that this project, which was first made available on January 26th 2023, is actively looking for participants. The 54 individuals required will be sourced from a single medical site."

Answered by AI

Is Test CTM Injection a risk-free form of treatment for patients?

"After carefully considering the available data, Test CTM Injection was rated a 2 on a scale from 1 to 3. This is because although there exists some evidence of its safety yet none that demonstrates efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of CTM for Tennis ELbow

2023. "Efficacy of CTM for Tennis ELbow". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06171555.

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