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

NCT04022928 | Completed

• 1 other identifier: VGHKS18-CT7-21
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Osteoarthritis

Keywords

Ankle joint; Osteoarthritis; Platelet rich plasma

Outcome Measures

Primary Outcomes (1)

• visual analog scale (VAS) of ankle pain

  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)

  6 months

Secondary Outcomes (6)

• The Ankle Osteoarthritis Scale (AOS) score

  6 months

• The American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score

  6 months

• The single-leg stance (SLS) test

  6 months

• use of analgesic medication

  through study completion, an average of 6 months

• global satisfaction

  6 months

Study Arms (1)

PRP injection

EXPERIMENTAL

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.

Other: PRP

Interventions

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.

PRP injection

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Veterans General Hospital Kaohsiung

Kaohsiung City, 813, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Shu Fen Sun, MD

  Kaohsiung Veterans General Hospital, Taiwan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neutorehabilitation, MD,Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 17, 2019
• Study Start: July 1, 2018
• Primary Completion: November 30, 2018
• Study Completion: May 30, 2019
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)