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

NCT ID: NCT04022928

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-05-30

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 .

Conditions

Ankle Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PRP

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role: lead

Responsible Party

Shu-Fen Sun

Director of Neutorehabilitation, MD,Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shu Fen Sun, MD

Role: STUDY_DIRECTOR

Kaohsiung Veterans General Hospital, Taiwan

Locations

Department of Physical Medicine and Rehabilitation, Veterans General Hospital Kaohsiung

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

VGHKS18-CT7-21

Identifier Type: -

Identifier Source: org_study_id