Register a trial

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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