A Clinical Registry of Orthobiologics Procedures

• Sponsor: Regenexx, LLC (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT03011398
• Collaborator: (none)
• Enrollment: 50,000
• Locations: 32
• Duration (Months): 240
• Patients Per Site: 1562.5
• Patients Per Site Per Month: 6.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Disorder	Procedure: Orthobiologic Procedures

Detailed 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 Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50000 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Interventional Orthopedics Foundation Patient Registry Database-A Clinical Registry of Orthobiologics Procedures
• Study Start Date: Feb 1, 2016
• Anticipated Primary Completion Date: Feb 1, 2036
• Anticipated Study Completion Date: Feb 1, 2036

Outcome Measures

Primary Outcome Measures

1. Change in Percent Improvement [1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]

   Mean improvement score, where -100=100% worse from baseline and 100=100% better or improved from baseline

Secondary Outcome Measures

1. Pain Scale [1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]

   Mean numeric pain score, where 0=no pain and 10=worst possible pain.

2. International Knee Documentation Committee form [1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]

   Mean IKDC score, where 0=lowest level of knee function and 100=highest level of knee function.

3. Lower Extremity Function Scale [1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]

   Means LEFS score, where 0=very low function of the lower extremity and 80=very high function of the lower extremity

4. Disabilities of the Arm, Shoulder and Hand form [1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]

   Mean DASH score, where 0=no disability of the upper extremity and 100=most severe disability of the upper extremity.

5. Oxford Hip Score [1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]

   Mean OHS score, where 42-48=excellent, 34-41=good, 27-33=fair, 0-26=poor for hip pain and function.

6. Functional Rating Index [1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]

   Mean FRI score, where 0=no disability in function of the neck and back and 100=severe disability.

7. Complications [1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]

   Description of any medical complication related to receiving a treatment procedure

8. Adverse Events [1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]

   Description of adverse events occurring after treatment procedure

9. Number of Re-injections to treated area [1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]

   number of additional injections to treated area such as platelet rich plasma or stem cell treatment

10. Number of Surgical Interventions to treated area [1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]

    Number of surgical interventions to treated area after receiving treatment procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catalyst Pain Solutions	Phoenix	Arizona	United States	85008
2	Healthlink Center	Beverly Hills	California	United States	90035
3	Healthlink Center	Oceanside	California	United States	92056
4	Healthlink Center	San Rafael	California	United States	94903
5	Southern California Orthopedic Institute	Thousand Oaks	California	United States	91361
6	Southern California Orthopedic Institute-Van Nuys	Van Nuys	California	United States	91405
7	Centeno-Schultz Clinic	Broomfield	Colorado	United States	80021
8	Regenexx	Broomfield	Colorado	United States	80026
9	New reGeneration Orthopedics	Sarasota	Florida	United States	34243
10	Chicago Arthritis	Chicago	Illinois	United States	60657
11	Orthopedic Stem Cell Resource	Des Plaines	Illinois	United States	60016
12	Harbor View Medical	Des Moines	Iowa	United States	50321
13	Bodyworks Musculoskeletal Medicine	Louisville	Kentucky	United States	40223
14	Total Care-LA	Lafayette	Louisiana	United States	70503
15	Stem Cell ARTS-MD	Chevy Chase	Maryland	United States	20815
16	RejuvMedical	Waite Park	Minnesota	United States	56387
17	New Jersey Sports Medicine	Cedar Knolls	New Jersey	United States	07927
18	Orthopedic Stem Cell Solutions	Oakhurst	New Jersey	United States	07755
19	Rehabilitation Center of New Jersey	Wayne	New Jersey	United States	07470
20	Rehabilitation Center of New York	New York	New York	United States	10001
21	Beacon Orthopaedics	Cincinnati	Ohio	United States	45241
22	ProMedica	Toledo	Ohio	United States	43612
23	RegenOrthoSport	Tulsa	Oklahoma	United States	74136
24	Columbia Pain Management	Hood River	Oregon	United States	97031
25	Rehabilitation and Pain Specialists	Pittsburgh	Pennsylvania	United States	15238
26	Center for Sports Medicine	Springfield	Pennsylvania	United States	19064
27	RegenOrthoSport	Dallas	Texas	United States	75230
28	Wasatch Pain Solutions	South Jordan	Utah	United States	84095
29	Vermont Regenerative Medicine	Winooski	Vermont	United States	05404
30	Stem Cell ARTS-VA	McLean	Virginia	United States	22102
31	Nepean Specialist Sports Medicine	Kingswood	New South Wales	Australia	2747
32	RegenOrthoSport	Hyderabad	Telangana	India	500001

Sponsors and Collaborators

• Regenexx, LLC

Investigators

• Principal Investigator: Christopher Centeno, MD, Regenerative Sciences, LLC and Centeno-Schultz Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Regenexx, LLC
• ClinicalTrials.gov Identifier: NCT03011398
• Other Study ID Numbers: RSI2015-REG01
• First Posted: Jan 5, 2017
• Last Update Posted: Jan 26, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Musculoskeletal Diseases

Study Results

No Results Posted as of Jan 26, 2022