A Single Intraarticular Injection of Platelet-Rich Plasma on Pain and Physical Function in Patients With Ankle OA

Overview

Platelet-rich plasma (PRP) has been reported to be an effective treatment for knee osteoarthritis (OA). The application in ankle OA has rarely been investigated. The aim was to evaluate the efficacy and safety of a single intraarticular injection of PRP for the treatment of patients with ankle OA.

Full Title of Study: “Efficacy and Safety of a Single Intraarticular Injection of Platelet-Rich Plasma on Pain and Physical Function in Patients With Ankle Osteoarthritis—a Prospective Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2018

Detailed Description

Methods: In a prospective study, patients with symptomatic ankle OA for at least 6 months were recruited. Patients received a single injection of 3-ml of PRP into symptomatic ankles. The primary outcome was the change from baseline in the visual analog scale (VAS) pain score (0-10cm) at 6 months. Secondary outcomes included the Ankle Osteoarthritis Scale (AOS) score, American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score, single leg stance test (SLS), use of rescue analgesics and patient satisfaction. Adverse events were recorded during the study.

Patients were followed at 1, 3 and 6 months postinjection .

Interventions

  • Other: PRP
    • , For PRP preparation, specialized platelet concentrate separator containing acid citrate dextrose as anticoagulant and a specific separator gel that harvest PR, preventing contamination of red blood cells and leukocytes were used.

Arms, Groups and Cohorts

  • Experimental: PRP injection
    • Patients with symptomatic ankle OA for at least 6 months were recruited. Patients received a single injection of 3-ml of PRP into symptomatic ankles.

Clinical Trial Outcome Measures

Primary Measures

  • visual analog scale (VAS) of ankle pain
    • Time Frame: 6 months
    • The patient rated the average severity of ankle pain on ankle movement over the previous week on a 10-cm VAS (0=no pain to 10=worst possible pain)

Secondary Measures

  • The Ankle Osteoarthritis Scale (AOS) score
    • Time Frame: 6 months
    • AOS score is a validated patient-rated outcome measure that contains a nine-item pain subscale and a nine-item disability subscale. Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable
  • The American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score
    • Time Frame: 6 months
    • a 100-point scale that devotes 40 points to pain, 50 points to function and 10 points to alignment. The maximum score of 100 points denotes no pain and normal function and alignment
  • The single-leg stance (SLS) test
    • Time Frame: 6 months
    • SLS test involved raising the unaffected foot, without touching it to the affected lower extremity, and maintaining balance for as long as possible. Each participant performed three trials, and the best result was recorded
  • use of analgesic medication
    • Time Frame: through study completion, an average of 6 months
    • The patient recorded the use of analgesic medication during the study period on a diary card.
  • global satisfaction
    • Time Frame: 6 months
    • The patients rated his or her level of global satisfaction relative to the state before the treatment, using a 100 mm VAS (0= completely dissatisfied, 100=completely satisfied)
  • safety of PRP for ankle
    • Time Frame: through study completion, an average of 6 months
    • The safety of the injection was monitored by recording the occurrence of systemic and local adverse events on a diary card

Participating in This Clinical Trial

Inclusion Criteria

  • Age of at least twenty years
  • Ankle pain lasted for at least 6 months, despite conservative treatment or inability to tolerate the side effects of medications
  • Ankle radiographs taken within 6 months (reviewed by the senior author) were equivalent to grade 1-4 osteoarthritis by the Kellgren Lawrence grading system
  • Average ankle pain of > 3cm on a 10-cm visual analog scale (VAS)
  • Radiological evidence of bilateral ankle osteoarthritis was accepted if VAS pain in the contralateral ankle was < 3 cm
  • Normal activity level, not bedridden or confined to a wheelchair, able to walk 30 meters without the aid of a walker, crutches or cane
  • No use of physical therapy or changes in shoes or orthotic devices during the study

Exclusion Criteria

  • Pregnancy or lactation in women
  • Lower leg trauma in a location other than within the ankle
  • Previous surgery involving the spine, hip or knee
  • The presence of an active infection of the ankle
  • Surgery involving the affected ankle within the previous 12 months
  • Intraarticular steroid or hyaluronate injection in the ankle within the previous 6 months
  • Treatment with anticoagulants or immunosuppressives
  • History of rheumatoid arthritis, gout, or other inflammatory arthropathy
  • The presence of visual or vestibular impairments
  • Poor health status (such as a neoplasm, diabetes mellitus, or paresis) that would interfere with the assessments

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kaohsiung Veterans General Hospital.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shu-Fen Sun, Director of Neutorehabilitation, MD,Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital – Kaohsiung Veterans General Hospital.
  • Overall Official(s)
    • Shu Fen Sun, MD, Study Director, Kaohsiung Veterans General Hospital, Taiwan

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