Injections of FloGraft Therapy, Autologous Stem Cells, or Platelet Rich Plasma for the Treatment of Degenerative Joint Pain

Arizona Pain Specialists

Status: Unknown

Conditions: Osteoarthritis; Rheumatoid Arthritis

Study type: Observational

Funder types: Other

Identifiers

NCT01978639

APS 2013-022

2013-022

Details and patient eligibility

About

This study will assess the outcomes of three currently available regenerative treatments (FloGraft, autologous stem cell therapy, platelet rich plasma therapy) for painful degenerative conditions of the joints. Patients receiving one these treatments will be assessed before the treatment procedure and followed up at four points over the six months after their procedure. Patients' pain, quality of life, and pain medication use at follow up will be compared to baseline levels. The investigators hypothesize that all three treatments will be effective in reducing pain, improving quality of life, and reducing pain medication usage.

Full description

This is an open-label, non-randomized study assessing the efficacy of three potentially regenerative treatments for degenerative conditions of the joints of the lower back (facet, sacroiliac), upper extremities (e.g., shoulder), and lower extremities (e.g., hip, knee). These treatments are:

1. A single injection of Applied Biologics' FloGraftTM.
2. A single injection of autologous bone marrow derived stem cells.
3. A single injection of platelet rich plasma.

Subjects will be assessed prior to treatment for their level of pain, quality of life, and pain medication usage. Subjects will be followed up at 4 weeks, 8 weeks, 12 weeks, and 24 weeks after treatment. At each of these follow up visits, pain, quality of life, and pain medication usage will be assessed.

The investigators hypothesize that all three treatment groups will experience reduced pain, improved quality of life, and reduced pain medication usage at follow up.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older,
• Ability to complete follow-up visits,
• Able to understand the study protocol and provide consent,
• Significant pain (average pain in the past month greater than or equal to 5, from 0-10),
• Pain lasting at least 3 months,
• Pain associated with one of the following conditions: lumbar facet degeneration, - OR -degenerative condition causing upper extremity joint pain, - OR - degenerative condition causing lower extremity joint pain.

Exclusion criteria

• Current litigation or worker's compensation claim,
• Unstable pain medication dosage,
• Previous surgery at the affected site,
• Injections at the affected site within the past 6 months,
• Uncontrolled psychiatric condition,
• Pregnancy or lactating in women,
• History of adverse reactions to local anesthetic