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Connective Tissue Matrix vs Steroid Injections for Rotator Cuff Tendinopathy

N/A

Recruiting

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

Patients aged 18-80 years old with rotator cuff tendinopathy

Be older than 18 years old

Must not have

Patients with adhesive capsulitis

Patients with acromio-clavicular joint impingement, retracted tears, significant labral lesions or significant glenohumeral arthrosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6, month 3, month 6 visits

Summary

This trial will compare the effectiveness of a single injection of Connective Tissue Matrix boost (CTM) versus a steroid shot in treating patients with rotator cuff tendinopathy. Patients will be randomly

Who is the study for?

This trial is for individuals with rotator cuff tendinopathy, a shoulder condition. Participants must meet certain health criteria to join but the specific inclusion and exclusion details are not provided here.

What is being tested?

The study compares two treatments for shoulder pain from rotator cuff tendinopathy: an injection of Connective Tissue Matrix (CTM) versus a standard steroid shot. Patients will be randomly assigned to one of these treatments without knowing which one they receive.

What are the potential side effects?

Possible side effects may include pain at the injection site, infection, allergic reactions, or worsening of symptoms. Specific side effects related to CTM are not detailed but can be similar to other injectable treatments.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 80 years old with rotator cuff tendinopathy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with frozen shoulder.

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I have shoulder issues including joint impingement or significant wear and tear.

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I have been on long-term steroids for a medical condition.

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I do not have conditions like severe kidney disease, uncontrolled diabetes, or immune system disorders.

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I have unstable joints.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6, month 3, month 6 visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6, month 3, month 6 visits

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Raw WORC Score at 3 Month Visit

Secondary study objectives

ASES

Functional Assessments: Empty can exercise

Functional Assessments: External Rotation with Dumbell

+6 more

Side effects data

From 2010 Phase 4 trial • 140 Patients • NCT01154153

Pyrexia

Epistaxis

Headache

100%

80%

60%

40%

20%

Study treatment Arm

TAA-AQ

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CTM BoostExperimental Treatment1 Intervention

TM Boost (CTM Biomedical, Miami, FL) is a decellularized Human Cellular and Tissue Based Allograft (HCT/P) derived from placental connective tissue. It is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is regulated as a minimally-manipulated biologic by the FDA and is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is administered applied into the tissue via injection. Participant will undergo a single injection of 2.0cc of the injectable CTM allograft, administered using a 20G needle in the subacromial space. 3mL of ropivacaine will be mixed into the syringe prior to administration of the injection. Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used.

Group II: CorticosteroidPlacebo Group1 Intervention

Kenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions. In this study, a 2.0cc dose injection of Kenalog-40 will be administered directly into the subacromial space using a 20G needle. 3mL of ropivacaine will be injected along with the steroid (as part of the same injection). Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used.

0 / 6Eligibility criteria met