A Randomized Clinical Trial Evaluating Platelet Rich Plasma Versus Hyaluronic-Acid in the Short-term Treatment of Symptomatic OA (Osteoarthritis) of the Hip
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hip Osteoarthritis
- Sponsor
- University of Colorado, Denver
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Sub-score
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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) of the hip. Secondarily, this study aims to determine the feasibility and safety of treating early OA of the hip with HA and PRP.
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. Analgesics and nonsteroidal anti-inflammatory drugs (NSAIDs) have suboptimal effectiveness, and there is concern of systemic side effects. A large challenge is the development of appropriate and effective therapy in patients with OA. Currently, the most suitable route for administering OA therapy appears to be intra-articular injections that allow accumulation of critical doses of the drug within the damaged area and also reduce the risk of systemic side effects. The primary objective of this study is to compare the clinical efficacy of intra-articular injections of Platelet Rich Plasma (PRP) vs. Hyaluronic Acid for symptomatic early OA of the hip. Secondarily, the study aims to evaluate the safety and feasibility of both medications delivered. Patients, which meet inclusion criteria, are confirmed eligible, and agree to enroll in the study, would be randomized and treated with either three intra-articular PRP injections or three intra-articular Hyaluronic Acid injections. If the patient has OA in both hips, they will be randomized to receive the same injection in both hips. The Primary investigator will be unblinded to the treatment that the subject is randomized to. The PI will only be involved in the initial assessment of the patient and the actual injections. All of the follow up visits, clinical assessments and outcome scores will be performed by the sub-investigator, who will also be the examining physician. The sub-investigator will be blinded to the treatment throughout the study. All of the study subjects will be blinded to which treatment that they are assigned to. Physical exams will be performed to assess range of motion of the hip joint. The difference in ranges of motion will be statistically compared at different time points between the two groups to determine the difference in improvement between the two compared to baseline. The primary efficacy outcome will be defined as the percentage of patients having a 50% decrease in the summed score for the WOMAC pain subscale from baseline to week 24. We will measure this outcome by applying the WOMAC questionnaire compared with baseline therapy. The secondary efficacy outcomes will also include IHOT and Non Arthritic Hip Score. An anterior posterior hip radiograph will be performed at 12 months and 24 months to assess Kellgren-Classification and compared to baseline.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Sub-score
Time Frame: Baseline, Week 24
The primary efficacy outcome was defined as the percentage of patients having a 50% decrease in the summed score for the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain sub-score from baseline to week 24. The WOMAC score is a normalized patient-reported outcome measure in which 0 represents the worst possible score and 100 represents the best possible score. The WOMAC is primarily used in osteoarthritis clinical trials to evaluate the effects of arthroplasty and drug interventions in patients with hip osteoarthritis. Thus, a 50% increase in the WOMAC pain sub-score would indicate reduced pain or improvement, while a 50% decrease would indicate worsening pain.
Survivorship, as Measured by the Frequency of Patient Withdrawal of Their Treated Hip to Undergo Surgery (Total Hip Arthroplasty [THA] or Hip Resurfacing Procedure).
Time Frame: Baseline, 24 Months
To measure duration of clinical benefit, survivorship was analyzed by investigating the frequency of patient withdrawal of their treated hip to undergo surgery (total hip arthroplasty \[THA\] or hip resurfacing procedure). Survivorship was evaluating hips, not patients in this outcome measure. This served as the primary outcome measure for the study.
Secondary Outcomes
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 6(Week 6)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 12(Week 12)
- Hip Range of Motion (ROM) at Baseline(Baseline)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Baseline(Baseline)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 24(Week 24)
- Hip Range of Motion (ROM) at Week 6(Week 6)
- Change in Hip Range of Motion (ROM)(Baseline, 24 Months)
- Hip Range of Motion (ROM) at Week 12(Week 12)
- Hip Range of Motion (ROM) at Week 24(Week 24)
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores(Baseline, Month 24)
- Change in International Hip Outcome Tool (IHOT)(Baseline, 24 Months)
- Change in Non-Arthritic Hip Score(Baseline, 24 Months)
- Change in Flexion-Abduction-External Rotation (FABER) Test.(Baseline, 24 Months)
- Change in Anterior Posterior (AP) Pelvis Radiograph/ Kellgren-Lawrence Grading Scale Classification.(Baseline, 24 Months)