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

NCT01920152 | Completed Results DMC

• 1 other identifier: 13-0142
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis

Keywords

Hip, Chondropenia, Osteoarthritis.

Outcome Measures

Primary Outcomes (2)

• Survivorship, as Measured by the Frequency of Patient Withdrawal of Their Treated Hip to Undergo Surgery (Total Hip Arthroplasty [THA] or Hip Resurfacing Procedure).

  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.

  Baseline, 24 Months

• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Sub-score

  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.

  Baseline, Week 24

Secondary Outcomes (14)

• Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Baseline

  Baseline

• 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

• Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 24

  Week 24

• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores

  Baseline, Month 24

Other Outcomes (1)

• Number of Patients With Adverse Events

  Week 2-Week 3 and 6-12-18-24 months

Study Arms (2)

Autologous PRP Hip Injection

EXPERIMENTAL

Patients randomized to this group of treatment will receive 3 blinded hip intra-articular injections of autologous Platelet-Rich Plasma one week apart from each other.

Biological: PRP

Hyaluronic Acid Hip Injection

ACTIVE COMPARATOR

Patients randomized to this group of treatment will receive 3 blinded hip intra-articular injections of hyaluronic acid (SUPARTZ hyaluronate/2.5ml) one week apart each other.

Device: Hyaluronic Acid

Interventions

PRP BIOLOGICAL

Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.

Autologous PRP Hip Injection

Hyaluronic Acid DEVICE

Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.

Also known as: SUPARTZ

Hyaluronic Acid Hip Injection

Eligibility Criteria

• Age: 30 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado, Hip Preservation Center, Orthopedic Department

Boulder, Colorado, 80304, United States

Location

Related Publications (6)

• 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.

  PMID: 23591381 BACKGROUND

• 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.

  PMID: 23333279 BACKGROUND

• 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.

  PMID: 22253252 BACKGROUND

• 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.

  PMID: 21678642 BACKGROUND

• 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.

  PMID: 21150152 BACKGROUND

• 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.

  PMID: 33786329 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Outcome measures descriptions are accurate to the approved protocol. Wording was modified slightly from the original registration for the purposes of results data reportability to the ClinicalTrials.gov data tables.

Results Point of Contact

• Title: Omer Mei-Dan, MD
• Organization: University of Colorado, Denver

omer.meidan@cuanschutz.edu

3033159900

Study Officials

• Omer Mei-Dan, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 9, 2013
• Study Start: August 1, 2013
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: March 3, 2021
• Results First Posted: January 25, 2021

Record last verified: 2021-02

Locations

US (1)