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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03011398




Registration number
NCT03011398
Ethics application status
Date submitted
29/12/2016
Date registered
5/01/2017
Date last updated
27/07/2020

Titles & IDs
Public title
A Clinical Registry of Orthobiologics Procedures
Scientific title
Interventional Orthopedics Foundation Patient Registry Database-A Clinical Registry of Orthobiologics Procedures
Secondary ID [1] 0 0
RSI2015-REG01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orthopedic Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Orthobiologic Procedures

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

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Percent Improvement - Mean improvement score, where -100=100% worse from baseline and 100=100% better or improved from baseline
Timepoint [1] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [1] 0 0
Pain Scale - Mean numeric pain score, where 0=no pain and 10=worst possible pain.
Timepoint [1] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [2] 0 0
International Knee Documentation Committee form - Mean IKDC score, where 0=lowest level of knee function and 100=highest level of knee function.
Timepoint [2] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [5] 0 0
Oxford Hip Score - Mean OHS score, where 42-48=excellent, 34-41=good, 27-33=fair, 0-26=poor for hip pain and function.
Timepoint [5] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [6] 0 0
Functional Rating Index - Mean FRI score, where 0=no disability in function of the neck and back and 100=severe disability.
Timepoint [6] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [7] 0 0
Complications - Description of any medical complication related to receiving a treatment procedure
Timepoint [7] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [8] 0 0
Adverse Events - Description of adverse events occurring after treatment procedure
Timepoint [8] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [9] 0 0
Number of Re-injections to treated area - number of additional injections to treated area such as platelet rich plasma or stem cell treatment
Timepoint [9] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcome [10] 0 0
Number of Surgical Interventions to treated area - Number of surgical interventions to treated area after receiving treatment procedure
Timepoint [10] 0 0
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- none

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Nepean Specialist Sports Medicine - Kingswood
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Vermont
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
India
State/province [21] 0 0
Telangana

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Regenexx, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03011398
Trial related presentations / publications
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Centeno, MD
Address 0 0
Regenerative Sciences, LLC and Centeno-Schultz Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03011398