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

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ClinicalTrials.gov Identifier: NCT01920152
Recruitment Status : Enrolling by invitation
First Posted : August 9, 2013
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Biological: PRP Device: Hyaluronic Acid Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Autologous PRP Hip Injection
Patients (n=40) 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
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.

Active Comparator: Hyaluronic Acid Hip Injection
Patients (n=40) 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
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.
Other Name: SUPARTZ




Primary Outcome Measures :
  1. Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) [ Time Frame: Baseline-24 months follow up ]
    The primary efficacy outcome will be 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 subscale from baseline to week 24.


Secondary Outcome Measures :
  1. Change in International Hip Outcome Tool (IHOT) [ Time Frame: Baseline-24 months post inoculation ]
    Subjective score variation in the International Hip Outcome Tool (IHOT) for both groups of treatment from baseline to 24 months post inoculation

  2. Change in Non Arthritic Hip Score [ Time Frame: Baseline-24 months ]
    Subjective score variation on the Non Arthritic Hip Score for both groups of treatment from baseline to 24 months post inoculation

  3. Change in Hip Range of motion (ROM) [ Time Frame: Baseline-24 months ]
    Score variation on hip range of motion for both groups of treatment from baseline to 24 months post inoculation

  4. Change in FABER TEST [ Time Frame: Baseline-24 months ]
    Score variation for FABER test for both groups of treatment from baseline to 24 months post inoculation

  5. Change in Anterior Posterior (AP) Pelvis Radiograph/ Kellgren-Lawrence classification. [ Time Frame: Baseline-24 months ]
    Score variation on the Kellgren-Lawrence score for both groups of treatment from baseline to 24 months post inoculation


Other Outcome Measures:
  1. Number of patients with Adverse Events [ Time Frame: Week 2-Week 3 and 6-12-18-24 months ]
    Type, duration and trend of every adverse event for each patient will be reported



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920152


Locations
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United States, Colorado
University of Colorado, Hip Preservation Center, Orthopedic Department
Boulder, Colorado, United States, 80304
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Omer Mei-Dan, MD University of Colorado, Denver

Publications:
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01920152     History of Changes
Other Study ID Numbers: 13-0142
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

Keywords provided by University of Colorado, Denver:
Hip, Chondropenia, Osteoarthritis.

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents