Status:
COMPLETED
Platelet Rich Plasma vs Hyaluronic-Acid in Hip OA (Osteoarthritis)
Lead Sponsor:
University of Colorado, Denver
Conditions:
Hip Osteoarthritis
Eligibility:
All Genders
30-72 years
Phase:
NA
Brief Summary
The objective of this study is to compare the clinical efficacy of intra-articular injections of autologous platelet rich plasma (PRP) vs hyaluronic acid (HA) for symptomatic early osteoarthritis (OA)...
Detailed Description
Osteoarthritis (OA) is a common, painful condition affect adults and causes mobility disability in the United States and Europe. Unfortunately, there is no agents available that halt OA progression. A...
Eligibility Criteria
Inclusion
- Male or female age 30-72 inclusive.
- Symptomatic early OA of the hip (Kellgren-Lawrence Grade 1-2-3) documented by x-ray taken within the past 6 months.
- Women of childbearing potential will be allowed to enroll but must be willing to practice one highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS) condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study.
Exclusion
- Patients with polyarticular disease.
- Patients with major conditions such as poorly control diabetes, Cardiac Heart Failure (CHF), Chronic Obstructive Pulmonary Disease (COPD) or untreated depression
- Patients with known blood disorders (Blood disorders (thrombopathy, thrombocytopenia, anemia with hemoglobin \<9g/dL).
- Patients who had intra-articular treatment with steroids within 6 months of randomization in this study or received more than 3 previous intra-articular steroid injections to the effected hip.
- Patients who are pregnant or nursing at the time of consent.
- Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis)
- Non-English speaking patients. (Scores used for evaluation have not been validated in Spanish)
- Patients who had previous hip surgery
- Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments.
- Chronic use of NSAID (defined as taking NSAID regularly every week for the last 6 months), steroids or chemotherapy drugs
- Treatment with NSAIDs within 2 days prior to randomization in this study
- Patients with a BMI over 30. Due to the fact that this study utilize an injection technique which may be inaccurate in obese subjects.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2019
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01920152
Start Date
August 1 2013
End Date
December 5 2019
Last Update
March 3 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado, Hip Preservation Center, Orthopedic Department
Boulder, Colorado, United States, 80304