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NCT Number: NCT04022928

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

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.

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Key information

Conditions

Ankle Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine and Rehabilitation, Veterans General Hospital Kaohsiung

Kaohsiung City, 813, Taiwan

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRP

Other

, 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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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)

  6. 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

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 17, 2019
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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