Health TrialsbyHealthPanel

Platelet Rich Plasma Versus Corticosteroids in Hip Osteoarthritis Pain

ConditionHip Osteoarthritis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21-80
SponsorLifeBridge Health

About this trial

Prospective, single-center that may go on to being multicenter, randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of Hip osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or female, aged 21-80 years

Radiographic diagnosis of Kellgren-Lawrence (KL) grade of II or III Hip osteoarthritis

Disqualifiers

Any injections into the target Hip within three months

Current overlying skin infection

Current or previous diagnosis of "chronic pain"

Opioid tolerant at time of screening (for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Platelet Rich Plasma Joint Injection

    Device

    Magellan Autologous Concentration System, ISTO Biologics

  • Corticosteroid Injection

    Drug

    5 milliliters (mL) injection of corticosteroid (1cc Kenalog, 4cc Xylocaine) Kenalog - 40 (triamcinolone acetonide injectable suspension, USP) Xylocaine - MPF (lidocaine HCl Injection, USP)

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Autologous Platelet Rich PlasmaExperimental treatment 1 intervention
Group B: CorticosteroidActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Score VAS

Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Pain intensity that is calculated by measuring the distance from the "no pain" end of a line to a mark placed by the patient to indicate their current pain level. This will be measured at baseline, six weeks, and three months.

Time frame
baseline, six weeks, and three months

Secondary outcomes

1

Pain Score NRS

Numeric Pain Rating Scale (NRPS) where patients are asked to rate their pain on a scale of 0 to 10, with 0 representing "no pain" and 10 representing "the worst pain imaginable. This will be measured at baseline, six weeks, and three months.

Time frame
baseline, six weeks, and three months.
2

Functional score HOOS

The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess patient's opinions about their hip and associated problems and to evaluate their symptoms and functional limitations during a therapeutic process. The HOOS includes 40 items with five possible responses, graded from 0 to 4 (0 points = worst possible score; 100 points = best possible score). Standardized answer options are given in 5 Likert boxes with scores from 0 to 4 (no, mild, moderate, severe and extreme) to answer the questions. This will be measured at baseline, six weeks, and three months.

Time frame
baseline, six weeks, and three months
3

Functional score HHS

The Harris Hip Scale (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The maximum score possible is 100. Results can be interpreted with the following\[1\]: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. This will be measured at baseline, six weeks, and three months.

Time frame
baseline, six weeks, and three months
4

Functional score WOMAC

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright. The total WOMAC score is the sum of the three subscale scores, with a possible score range of 0-96. Higher scores indicate worse pain, stiffness, and functional limitations. This will be measured at baseline, six weeks, and three months.

Time frame
baseline, six weeks, and three months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LifeBridge Health

Lead sponsor

Hip Society

Collaborator

Source ClinicalTrials.gov
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