NCT02034032

Brief Summary

The primary objective of this study is to evaluate the efficacy of Regenexx SD compared to Exercise Therapy at three months. Historical comparison will be made to Total Knee Arthroplasty for treatment of knee osteoarthritis at 1 and 2 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

4.4 years

First QC Date

January 9, 2014

Last Update Submit

January 3, 2019

Conditions

Knee Osteoarthritis

Keywords

OsteoarthritisKneeArthritisTKATotal Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Knee Society Scores

    Mean difference of Knee Society Scores for assessment and function between the treatment groups measured at 3 months

    3 months

Secondary Outcomes (2)

  • KSS means difference between Regenexx SD and historical TKA data

    1 year

  • KSS means difference between Regenexx SD and historical TKA data

    2 year

Study Arms (2)

Regenexx SD

ACTIVE COMPARATOR

Regenexx-SD (Same Day) is a bone marrow based injection procedure.

Procedure: Regenexx SD

Exercise Therapy

ACTIVE COMPARATOR

Subjects in the Exercise Therapy group will attend an initial session with a trained Physical Therapist. During that session the physical therapist will instruct the subject in a home exercise program and instructions about activity limitations. The subject's progress will also be followed by the Physical Therapist during the 6 week follow-up visit with further instructions provided.

Behavioral: Exercise Therapy

Interventions

Regenexx SDPROCEDURE

stem cell treatment

Regenexx SD
Exercise TherapyBEHAVIORAL

exercise therapy control

Exercise Therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary signature of the IRB approved Informed Consent
  • Ages 18 to 70
  • Diagnosis of Knee osteoarthritis
  • Kellgren-Lawrence Grade 2 or 3 on X-Ray
  • BMI of \<30
  • Minimum flexion to 110 degrees
  • Varus under 12 degrees/Valgus under 15 degrees
  • Instability in any plane less than 2 mm translation
  • ACL intact and no history of ACL reconstruction
  • Knee Society 100 point score \> 65
  • If bilateral arthritis, subject must be able and willing to delay treatment of the second side for at least 6 months
  • Candidate is able to follow Regenexx medication guidelines
  • Patient agrees to return for periodic assessment protocol
  • Patient must execute all required documents
  • Patient must be appraised of Clinical Trial

You may not qualify if:

  • History of infection of the joint in the last five years
  • Intra-articular PRP, steroid or viscosupplementation in the last three months
  • Previous knee surgery within the last 6 months
  • Flexion contracture over 15 degrees
  • Low back pain with radiculopathy or with "significant" radiographic changes
  • History of immunosuppressive or chemotherapy in the last five years
  • Systemic neurological disease
  • HIV positive or chronic hepatitis
  • Any significant co-morbidity that in the opinion of the investigator should exclude the subject from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regenerative Pain Center; Weil Foot, Ankle and Orthopedic Institute

Des Plaines, Illinois, 60016, United States

Location

Related Publications (1)

  • Centeno C, Sheinkop M, Dodson E, Stemper I, Williams C, Hyzy M, Ichim T, Freeman M. A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis: a randomized controlled trial with 2 year follow-up. J Transl Med. 2018 Dec 13;16(1):355. doi: 10.1186/s12967-018-1736-8.

    PMID: 30545387DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisArthritis

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Mitchell Sheinkop, M.D.

    Regenerative Pain Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 13, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

January 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)