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

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

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.

Study Overview

• Status: Completed
• Conditions: Ankle Osteoarthritis
• Intervention / Treatment: Other: PRP

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 .

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 813
    • Department of Physical Medicine and Rehabilitation, Veterans General Hospital Kaohsiung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Ankle Osteoarthritis Scale (AOS) score	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	6 months
The American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score	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	6 months
The single-leg stance (SLS) test	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	6 months
use of analgesic medication	The patient recorded the use of analgesic medication during the study period on a diary card.	through study completion, an average of 6 months
global satisfaction	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 months
safety of PRP for ankle	The safety of the injection was monitored by recording the occurrence of systemic and local adverse events on a diary card	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Kaohsiung Veterans General Hospital.
• Investigators: Study Director: Shu Fen Sun, MD, Kaohsiung Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Osteoarthritis; Platelet rich plasma; Ankle joint
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: VGHKS18-CT7-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No