Platelet Rich Plasma vs Hyaluronic-Acid in Hip OA (Osteoarthritis)

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.

Inclusion Criteria:

- Male or female age 35-72 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

- 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.