Examining the Effectiveness of a Connective Tissue Matrix Implant in Reducing Post-operative Pain and Narcotic After Outpatient Arthroscopic Shoulder Surgery

NCT04633837 | Terminated Results DMC FDA Device

• 1 other identifier: 1294348
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This document is a protocol for a human research study. This study is to be conducted according to United States standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures. Extracellular matrix grafts have been used to help with postoperative inflammation.

Conditions

Arthroscopic Shoulder Surgery; Pain, Postoperative

Keywords

extracellular matrix implant

Outcome Measures

Primary Outcomes (2)

• Patient Reported Post Operative Opioid Use

  Utilizing a prospective randomized controlled trial, narcotic use will be measured for 24-hour increments for a total of 7 post-operative days (PODs) then once on POD 14, 21, 28, and 42. Consumption will be measured by the number of tablets ingested and converted to morphine equivalent units and compared between the two treatment groups

  Up till 6 weeks

• Patient Reported Postoperative Pain: Visual Analogue Pain

  Utilizing a prospective randomized controlled trial, post-operative patient-reported VAS pain (on a scale of 0-10) will be collected 1 time per day (every 24 hours) for 7 post-operative days (PODs); then an average score collected on POD 14, POD 21, POD 28, and POD 42. Scores will be averaged and compared between the two treatment groups for the first 7 days, 2 week, 3rd week, 4th week and 6th week postoperatively. A score of zero will indicate no pain and a score of 10 will indicated maximum pain.

  Up till 6 weeks

Secondary Outcomes (1)

• American Shoulder and Elbow Scores

  Up till 6 months

Other Outcomes (2)

• Patient Reported Single Assessment Numeric Evaluation (SANE) Score

  Up till 6 months

• Shoulder Range of Motion

  Up till 6 months

Study Arms (2)

Group 1 Control

NO INTERVENTION

Group 1 will undergo standard arthroscopic shoulder surgery without the ECM injection.

Group 2: ECM Injectable graft

ACTIVE COMPARATOR

Group 2 will undergo arthroscopic shoulder surgery and receive 2cc of the injectable extracellular matrix injection placed into the glenohumeral joint space via a transtendon approach at the end of the surgery

Device: Extracellular Matrix Graft Injectable Implant

Interventions

Extracellular Matrix Graft Injectable Implant DEVICE

The extracellular matrix injectable implant will serve as the intervention in this study.

Also known as: CTM graft

Group 2: ECM Injectable graft

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 and older
• Primary diagnosis of rotator cuff tear, labral tear or SLAP tear
• Able to provide informed consent
• Is willing and able to accept text messages

You may not qualify if:

• Older than 55 years old.
• Pregnancy.
• Known narcotic or alcohol abuse (\< 3 months)
• Revision shoulder surgery
• Current narcotic regimen or contract with pain management specialist

Sponsors & Collaborators

• Brian Badman: lead
• CTM Biomedical: collaborator

Study Sites (1)

American Health Network

Avon, Indiana, 46123, United States

Location

Related Publications (3)

• Colvin AC, Egorova N, Harrison AK, Moskowitz A, Flatow EL. National trends in rotator cuff repair. J Bone Joint Surg Am. 2012 Feb 1;94(3):227-33. doi: 10.2106/JBJS.J.00739.

  PMID: 22298054 BACKGROUND

• Duellman TJ, Gaffigan C, Milbrandt JC, Allan DG. Multi-modal, pre-emptive analgesia decreases the length of hospital stay following total joint arthroplasty. Orthopedics. 2009 Mar;32(3):167.

  PMID: 19309064 BACKGROUND

• Parvataneni HK, Shah VP, Howard H, Cole N, Ranawat AS, Ranawat CS. Controlling pain after total hip and knee arthroplasty using a multimodal protocol with local periarticular injections: a prospective randomized study. J Arthroplasty. 2007 Sep;22(6 Suppl 2):33-8. doi: 10.1016/j.arth.2007.03.034. Epub 2007 Jul 26.

  PMID: 17823012 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Trial terminated early because of technical problems with participant-reported data collection system. No outcome measure data was collected from participants. Once technical problems were identified and determined to be irreparable, the trial was terminated.

Results Point of Contact

• Title: Brian Badman
• Organization: American Health Network

bbadman@gmail.com

317-208-3866

Study Officials

• brian l badman, MD

  American Health Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a double-blinded study, thus, neither the surgeon nor the patient will know if the extracellular matrix injection was given. A total of 70 envelopes will be made with 35 containing a card designating "treatment" and 35 designating "control". Envelopes will be randomly opened at completion of the surgery and if the treatment group is selected the patient will be administered the injectable extracellular matrix graft. Dr. Badman will place a 22 gauge needle transtendon into the glenohumeral joint space and will then exit the room prior to the envelope being opened. If the treatment group is selected, his physician assistant will administer the injection. If the control group is selected, the needle will be removed and no injection will be given.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopedic Surgeon

Model Details: The extracellular matrix implant injection is the intervention in this study. One group of patients undergoing arthroscopic shoulder surgery will receive 2cc of the injectable implant placed into the glenohumeral joint space at completion of the rotator cuff repair and the other group will not.

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: November 18, 2020
• Study Start: December 4, 2020
• Primary Completion: November 7, 2021
• Study Completion: November 7, 2021
• Last Updated: January 6, 2022
• Results First Posted: January 6, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)