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OpenTrials
Completed

NCT Number: NCT01601951

Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis

The purpose of this study is to determine if Bone Marrow Concentrate may be successful in the treatment of osteoarthritis. Bone Marrow Concentrate is known to contain a community of cells that has been shown to have "regenerative" properties. This study is designed to evaluate the short-term clinical and x-ray outcomes of injections for hip and knee osteoarthritis.

Inclusion Criteria:

* Subjects must be scheduled for an autologous bone marrow hip or knee injection * Subjects must have a diagnosis of hip or knee osteoarthritis * Subjects must be between the ages of 18 and 85 * Subjects must be willing and able to sign Informed Consent * Subjects must be willing and able to return for scheduled follow-up evaluations

Exclusion Criteria:

* Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment * Subjects for whom baseline data is not available

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Key information

Conditions

HIP AND KNEE OSTEOARTHRITIS Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Regenerative Pain Center

Des Plaines, Illinois, 60016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must be scheduled for an autologous bone marrow hip or knee injection
  • Subjects must have a diagnosis of hip or knee osteoarthritis
  • Subjects must be between the ages of 18 and 85
  • Subjects must be willing and able to sign Informed Consent
  • Subjects must be willing and able to return for scheduled follow-up evaluations

Exclusion criteria

  • Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment
  • Subjects for whom baseline data is not available

Treatment and study plan

Procedural, Bone Marrow concentrate injection

Other

This is strictly data collection and outcomes based. The procedure is not part of this study

Primary outcomes

  1. Visual Analog Pain Scale

    Time frame: Baseline, 6 weeks, 3 months, 1 year

    Change in subjective pain measure

  2. Harris Hip Score or Knee Society Score

    Time frame: Baeline, 6 weeks, 3 months, 1 year

    Change in subjective pain, function, functional activity measurement and a clinical physical exam

  3. Physician Global Assessment

    Time frame: Baseline, 6 weeks, 3 months, 1 year

    Change in physician rated disease activity measurement

Secondary outcomes

  1. Radiologic

    Time frame: Baseline, 1 year

    Radiographic changes of the hip or knee

Sponsors and collaborators

Lead sponsor

Regenerative Pain Center, Illinois

Other

Registry information

Official study title

Autologous Bone Marrow Concentrate Database Outcomes Research Project

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 18, 2012
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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