a Single Intraarticular Injection of PRP for Early Knee OA

NCT04027738 | Completed

• 1 other identifier: VGHKS106-131
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthritis

Keywords

knee; Osteoarthritis; Platelet rich plasma

Outcome Measures

Primary Outcomes (1)

• VAS pain

  The primary outcome was the change from baseline in the VAS pain score at 6 months. The patient rated the average severity of knee pain on knee movement over the previous week on a 0-100 mm VAS (0=no pain to 100=worst possible pain)

  6 months

Secondary Outcomes (5)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  6 months

• Lequesne index

  6 months

• Single-leg stance test (SLS)

  6 months

• Patients satisfaction

  6 months

• safety assessment

  during the study, for 6 months

Study Arms (1)

PRP injection

EXPERIMENTAL

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

Other: PRP

Interventions

PRP 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.

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Veterans General Hospital,

Kaohsiung City, 813, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Shu Fen Sun, MD

  Kaohsiung Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

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: Clinical trials with a single arm

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 22, 2019
• Study Start: January 1, 2017
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

TW (1)