← Back to Search

Other

CTM Treatment for Tendinopathy (CTM RCT Trial)

Phase 4

Recruiting

Led By Patrick Demeo, MD

Research Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

CTM RCT Trial Summary

This trial will study if one injection of CTM Boost or PRP can help reduce pain from rotator cuff tendinopathy.

Who is the study for?

This trial is for adults aged 18-80 with rotator cuff tendinopathy who are deemed suitable for PRP or CTM-type injection treatments. It's not open to those with certain shoulder conditions, a history of recent shoulder surgery or injections, or medical issues affecting healing like severe kidney disease or uncontrolled diabetes.Check my eligibility

What is being tested?

The study is testing the effectiveness of a single CTM Boost injection compared to a single platelet rich plasma (PRP) injection in reducing symptoms of rotator cuff tendinopathy. Participants will receive one of these treatments based on what their doctor thinks is best.See study design

What are the potential side effects?

Potential side effects from PRP and CTM Boost injections may include pain at the injection site, swelling, stiffness, and possible infection. These reactions are generally mild and temporary but can vary between individuals.

CTM RCT Trial 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

determine if injection of CTM Boost is non-inferior to injection of PRP

Secondary outcome measures

assessment of superiority of CTM to PRP (if non-inferiority established)

safety of injection of CTM boost compared to PRP

severity of tendinopathy

CTM RCT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CTM TreatmentExperimental Treatment1 Intervention

2.0 cc (cubic centimeter) dose injection of CTM Boost will be administered by injection directly into the rotator cuff using a 20 gauge needle.

Group II: PRP TreatmentActive Control1 Intervention

Each participant randomized to this arm will receive a single injection of Platelet Rich Plasma (PRP).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Connective Tissue Matrix Biomedical, LLCUNKNOWN

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor

47 Previous Clinical Trials

12,987 Total Patients Enrolled

Patrick Demeo, MDPrincipal InvestigatorAllegheny Health Network

Frequently Asked Questions

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

Is this research open to geriatric patients?

"According to this trial's inclusion criteria, the minimum age is 18 and the maximum age limit for enrollment is 80."

Answered by AI

Could I potentially qualify to join this experiment?

"This trial has 92 open spots and those who meet the criteria can apply. To be eligible, participants must suffer from shoulder pain and have an age that falls within 18 to 80 years old."

Answered by AI

Are there any opportunities for participants to join in this experiment?

"Contrary to expectations, the clinical trial detailed on clinicaltrials.gov has concluded recruitment for participants. Initially posted on January 15th 2024 and last edited November 29th 2023, this research endeavour is no longer seeking patients; however there are currently 224 other medical studies recruiting volunteers."

Answered by AI

Has CTM Treatment been certified by the Food and Drug Administration?

"As this is a Phase 4 trial, indicating that the CTM Treatment has been approved after multiple rounds of data collection, its safety was rated at 3 on our scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Connective Tissue Matrix for Rotator Cuff Tendinopathy

Patrick DeMeo, MD 2023. "Connective Tissue Matrix for Rotator Cuff Tendinopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06160427.

All > Paid Studies Pittsburgh