Clinical trial NCT01920152: Platelet Rich Plasma vs Hyaluronic-Acid in Hip OA (Osteoarthritis)
Official title: A Randomized Clinical Trial Evaluating Platelet Rich Plasma Versus Hyaluronic-Acid in the Short-term Treatment of Symptomatic OA (Osteoarthritis) of the Hip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: Hip, Chondropenia, Osteoarthritis.
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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.

Primary outcomes:
measure: Survivorship, as Measured by the Frequency of Patient Withdrawal of Their Treated Hip to Undergo Surgery (Total Hip Arthroplasty [THA] or Hip Resurfacing Procedure).
timeFrame: Baseline, 24 Months
measure: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Sub-score
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Baseline
timeFrame: Baseline
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 6
timeFrame: Week 6
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 12
timeFrame: Week 12
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 24
timeFrame: Week 24
measure: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores
timeFrame: Baseline, Month 24
measure: Hip Range of Motion (ROM) at Baseline
timeFrame: Baseline
measure: Hip Range of Motion (ROM) at Week 6
timeFrame: Week 6
measure: Hip Range of Motion (ROM) at Week 12
timeFrame: Week 12
measure: Hip Range of Motion (ROM) at Week 24
timeFrame: Week 24
measure: Change in Hip Range of Motion (ROM)
timeFrame: Baseline, 24 Months
measure: Change in International Hip Outcome Tool (IHOT)
timeFrame: Baseline, 24 Months
measure: Change in Non-Arthritic Hip Score
timeFrame: Baseline, 24 Months
measure: Change in Flexion-Abduction-External Rotation (FABER) Test.
timeFrame: Baseline, 24 Months
measure: Change in Anterior Posterior (AP) Pelvis Radiograph/ Kellgren-Lawrence Grading Scale Classification.
timeFrame: Baseline, 24 Months
Other outcomes:
measure: Number of Patients With Adverse Events
timeFrame: Week 2-Week 3 and 6-12-18-24 months
Locations:
city: Boulder
country: United States
facility: University of Colorado, Hip Preservation Center, Orthopedic Department
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Omer Mei-Dan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mei-Dan O, McConkey MO, Petersen B, McCarty E, Moreira B, Young DA. The anterior approach for a non-image-guided intra-articular hip injection. Arthroscopy. 2013 Jun;29(6):1025-33. doi: 10.1016/j.arthro.2013.02.014. Epub 2013 Apr 13.
citation: Mei-Dan O, Carmont M, Laver L, Mann G, Maffulli N, Nyska M. Intra-articular injections of hyaluronic acid in osteoarthritis of the subtalar joint: a pilot study. J Foot Ankle Surg. 2013 Mar-Apr;52(2):172-6. doi: 10.1053/j.jfas.2012.12.008. Epub 2013 Jan 17.
citation: Mei-Dan O, Carmont MR, Laver L, Mann G, Maffulli N, Nyska M. Platelet-rich plasma or hyaluronate in the management of osteochondral lesions of the talus. Am J Sports Med. 2012 Mar;40(3):534-41. doi: 10.1177/0363546511431238. Epub 2012 Jan 17.
citation: Mei-Dan O, Laver L, Nyska M, Mann G. [Platelet rich plasma--a new biotechnology for treatment of sports injuries]. Harefuah. 2011 May;150(5):453-7, 490. Hebrew.
citation: Mei-Dan O, Lippi G, Sanchez M, Andia I, Maffulli N. Autologous platelet-rich plasma: a revolution in soft tissue sports injury management? Phys Sportsmed. 2010 Dec;38(4):127-35. doi: 10.3810/psm.2010.12.1835.
citation: Kraeutler MJ, Houck DA, Garabekyan T, Miller SL, Dragoo JL, Mei-Dan O. Comparing Intra-articular Injections of Leukocyte-Poor Platelet-Rich Plasma Versus Low-Molecular Weight Hyaluronic Acid for the Treatment of Symptomatic Osteoarthritis of the Hip: A Double-Blind, Randomized Pilot Study. Orthop J Sports Med. 2021 Jan 20;9(1):2325967120969210. doi: 10.1177/2325967120969210. eCollection 2021 Jan.