a Single Intraarticular Injection of PRP for Early Knee OA

NCT ID: NCT04027738

Last Updated: 2019-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2017-12-30

Brief Summary

This study aimed to investigate the efficacy of a single intraarticular injection of PRP for the treatment of early knee OA.

Detailed Description

Platelet-rich plasma (PRP) has been reported to be effective for the treatment of knee osteoarthritis (OA). This study aimed to investigate the efficacy of a single intraarticular injection of PRP for the treatment of early knee OA.

In a prospective trial with 6-month follow-up, patients with early knee OA were recruited and received a single intraarticular PRP injection. Several outcomes were measured.

Conditions

Knee Osteoarthritis

Study Design

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

Study Groups

PRP injection

The patients received a single 3-ml injection of PRP.

Group Type: EXPERIMENTAL

PRP

Intervention Type: OTHER

The patients received a single 3-ml injection of PRP. Approximately 10-mL of venous blood was drawn from each patient and centrifuged using an Arthrex autologous conditioned plasma (ACP) kit (a low-leukocyte ACP system), spun at a speed of 1500 rpm for 5 minutes. The platelet concentration obtained was approximately 2-3 times greater than the baseline platelet concentration.

Interventions

PRP

The patients received a single 3-ml injection of PRP. Approximately 10-mL of venous blood was drawn from each patient and centrifuged using an Arthrex autologous conditioned plasma (ACP) kit (a low-leukocyte ACP system), spun at a speed of 1500 rpm for 5 minutes. The platelet concentration obtained was approximately 2-3 times greater than the baseline platelet concentration.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• aged 20-70 years
• symptomatic knee OA with pain for at least 6 months despite conservative treatment such as analgesics, NSAIDs and/or physical therapy
• average knee pain of at least 30 mm on a 100-mm visual analog (VAS) scale
• grade 1 or 2 knee OA according to the Kellgren-Lawrence grading system based on -radiographs taken within the previous 6 months
• Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm.

Exclusion Criteria

• previous orthopedic surgery on the spine or lower limbs
• disabling OA of either hip or foot
• knee instability or marked valgus/varus deformity
• history of severe knee trauma; intraarticular injections into the knee in the past 6 months
• infections or skin diseases around the target knee
• women ascertained or suspected pregnancy or lactating
• presence of malignancy, hematological disease, collagen vascular diseases, or autoimmune diseases;
• therapy with anticoagulants or anti-aggregating agent
• serious medical conditions that would interfere with the assessments during the study.

• 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: PRINCIPAL_INVESTIGATOR

Kaohsiung Veterans General Hospital, Taiwan

Locations

Department of Physical Medicine and Rehabilitation, Veterans General Hospital,

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

VGHKS106-131

Identifier Type: -

Identifier Source: org_study_id