Clinical trial NCT04022928: A Single Intraarticular Injection of Platelet-Rich Plasma on Pain and Physical Function in Patients With Ankle OA
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Osteoarthritis
Keywords: Ankle joint
Osteoarthritis
Platelet rich plasma
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

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 .

Eligibility criteria: 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

Primary outcomes:
measure: visual analog scale (VAS) of ankle pain
timeFrame: 6 months
Secondary outcomes:
measure: The Ankle Osteoarthritis Scale (AOS) score
timeFrame: 6 months
measure: The American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score
timeFrame: 6 months
measure: The single-leg stance (SLS) test
timeFrame: 6 months
measure: use of analgesic medication
timeFrame: through study completion, an average of 6 months
measure: global satisfaction
timeFrame: 6 months
measure: safety of PRP for ankle
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, Veterans General Hospital Kaohsiung
Study officials:
affiliation: Kaohsiung Veterans General Hospital, Taiwan
name: Shu Fen Sun, MD
role: STUDY_DIRECTOR
References: