A Clinical Registry of Orthobiologics Procedures

Orthopedic Disorder Clinical Trial

Official title:

Interventional Orthopedics Foundation Patient Registry Database-A Clinical Registry of Orthobiologics Procedures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03011398
• Other study ID #: RSI2015-REG01
• Status: Enrolling by invitation
• Start date: February 2016
• Est. completion date: February 2036

Study information

• Verified date: September 2023
• Source: Regenexx, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of the Registry study is to observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures for treatment of musculoskeletal disorders.

Description:

This Registry was designed to assure that the benefits and knowledge gained by studying clinical outcomes associated with the use of percutaneous orthopedic procedures outweigh the potential risks to the patients. The primary objective of this Registry is to observe the improvements in subject-reported clinical outcomes for these procedures used to treat musculoskeletal disorders. Secondary objectives include evaluating post-treatment complication, adverse events, re-injections, and surgical intervention. Patients receiving percutaneous orthopedic treatments are asked to enroll before receiving treatment and complete a set of baseline questionnaires regarding pain and functionality of the area of the body being treated (i.e. knee, shoulder, spine, etc). Follow-up outcomes are collected at 1 month, 3 months, 6 months, 12 months, 18 months, and annually 2-20 years post-injection. Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50000
• Est. completion date: February 2036
• Est. primary completion date: February 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Candidates must meet ALL of the following:

1. Voluntary signature of the IRB approved Informed Consents,

2. Treated with a Regenexx procedure

3. Have a musculoskeletal condition appropriate for the procedure such as osteoarthritis or internal joint derangement; ligament or tendon injury; intervertebral disc degeneration; protrusion, extrusion, or annular tear; muscle tear

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Procedure:
• Orthobiologic Procedures
To observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures used to treat musculoskeletal disorders.

Locations

Country	Name	City	State
Australia	Nepean Specialist Sports Medicine	Kingswood	New South Wales
India	RegenOrthoSport	Hyderabad	Telangana
United States	Healthlink Center	Beverly Hills	California
United States	Centeno-Schultz Clinic	Broomfield	Colorado
United States	Regenexx	Broomfield	Colorado
United States	New Jersey Sports Medicine	Cedar Knolls	New Jersey
United States	Stem Cell ARTS-MD	Chevy Chase	Maryland
United States	Chicago Arthritis	Chicago	Illinois
United States	Beacon Orthopaedics	Cincinnati	Ohio
United States	RegenOrthoSport	Dallas	Texas
United States	Harbor View Medical	Des Moines	Iowa
United States	Orthopedic Stem Cell Resource	Des Plaines	Illinois
United States	Columbia Pain Management	Hood River	Oregon
United States	Total Care-LA	Lafayette	Louisiana
United States	Bodyworks Musculoskeletal Medicine	Louisville	Kentucky
United States	Stem Cell ARTS-VA	McLean	Virginia
United States	Rehabilitation Center of New York	New York	New York
United States	Orthopedic Stem Cell Solutions	Oakhurst	New Jersey
United States	Healthlink Center	Oceanside	California
United States	Catalyst Pain Solutions	Phoenix	Arizona
United States	Rehabilitation and Pain Specialists	Pittsburgh	Pennsylvania
United States	Healthlink Center	San Rafael	California
United States	New reGeneration Orthopedics	Sarasota	Florida
United States	Wasatch Pain Solutions	South Jordan	Utah
United States	Center for Sports Medicine	Springfield	Pennsylvania
United States	Southern California Orthopedic Institute	Thousand Oaks	California
United States	ProMedica	Toledo	Ohio
United States	RegenOrthoSport	Tulsa	Oklahoma
United States	Southern California Orthopedic Institute-Van Nuys	Van Nuys	California
United States	RejuvMedical	Waite Park	Minnesota
United States	Rehabilitation Center of New Jersey	Wayne	New Jersey
United States	Vermont Regenerative Medicine	Winooski	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Regenexx, LLC

Countries where clinical trial is conducted

United States,  Australia,  India, 

References & Publications (5)

Bain BJ. Morbidity associated with bone marrow aspiration and trephine biopsy - a review of UK data for 2004. Haematologica. 2006 Sep;91(9):1293-4. — View Citation

Centeno CJ, Schultz JR, Cheever M, Freeman M, Faulkner S, Robinson B, Hanson R. Safety and complications reporting update on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2011 Dec;6(4):368-78. doi: 10.2174/157488811797904371. — View Citation

Centeno CJ, Schultz JR, Cheever M, Robinson B, Freeman M, Marasco W. Safety and complications reporting on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2010 Mar;5(1):81-93. doi: 10.2174/157488810790442796. — View Citation

Nejadnik H, Hui JH, Feng Choong EP, Tai BC, Lee EH. Autologous bone marrow-derived mesenchymal stem cells versus autologous chondrocyte implantation: an observational cohort study. Am J Sports Med. 2010 Jun;38(6):1110-6. doi: 10.1177/0363546509359067. Epub 2010 Apr 14. — View Citation

Wakitani S, Okabe T, Horibe S, Mitsuoka T, Saito M, Koyama T, Nawata M, Tensho K, Kato H, Uematsu K, Kuroda R, Kurosaka M, Yoshiya S, Hattori K, Ohgushi H. Safety of autologous bone marrow-derived mesenchymal stem cell transplantation for cartilage repair in 41 patients with 45 joints followed for up to 11 years and 5 months. J Tissue Eng Regen Med. 2011 Feb;5(2):146-50. doi: 10.1002/term.299. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Percent Improvement	Mean improvement score, where -100=100% worse from baseline and 100=100% better or improved from baseline	1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary	Pain Scale	Mean numeric pain score, where 0=no pain and 10=worst possible pain.	1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary	International Knee Documentation Committee form	Mean IKDC score, where 0=lowest level of knee function and 100=highest level of knee function.	1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary	Lower Extremity Function Scale	Means LEFS score, where 0=very low function of the lower extremity and 80=very high function of the lower extremity	1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary	Disabilities of the Arm, Shoulder and Hand form	Mean DASH score, where 0=no disability of the upper extremity and 100=most severe disability of the upper extremity.	1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary	Oxford Hip Score	Mean OHS score, where 42-48=excellent, 34-41=good, 27-33=fair, 0-26=poor for hip pain and function.	1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary	Functional Rating Index	Mean FRI score, where 0=no disability in function of the neck and back and 100=severe disability.	1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary	Complications	Description of any medical complication related to receiving a treatment procedure	1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary	Adverse Events	Description of adverse events occurring after treatment procedure	1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary	Number of Re-injections to treated area	number of additional injections to treated area such as platelet rich plasma or stem cell treatment	1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary	Number of Surgical Interventions to treated area	Number of surgical interventions to treated area after receiving treatment procedure	1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment