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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03011398
Ethics application status
Date submitted
29/12/2016
Date registered
5/01/2017

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
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
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
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
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
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
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
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
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
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
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
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
Sex
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
1/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2036
Actual
Sample size
Target
50000
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03011398