a Single Intraarticular Injection of PRP for Early Knee OA

Knee Osteoarthritis Clinical Trial

Official title:

Efficacy of a Single Intraarticular Injection of Platelet-Rich Plasma for the Treatment of Early Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04027738
• Other study ID #: VGHKS106-131
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: July 2019
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, Veterans General Hospital,	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale) is a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function [17]. The patient answers the questions and then receives a cumulative score in each of the 3 areas (pain, 0-20; stiffness, 0-8; physical function, 0-68). Total score is 96 and higher scores indicate worse outcomes.	6 months
Secondary	Lequesne index	Lequesne index is used to assess severity of knee symptoms during the last week .It is validated and includes the measurement of pain (5 items), walking distance (2 items), and activities of daily living (4 items). Maximal score is 24 and higher scores represent worse function.	6 months
Secondary	Single-leg stance test (SLS)	Single-leg stance test (SLS) is done by raising one foot up without touching it to the supported lower extremity with target knee and maintain balance for as long as possible. Each participant performed 3 trials, and the best result of the 3 trials was recorded	6 months
Secondary	Patients satisfaction	Patients were asked to rate their treatment satisfaction compared to the preinjection condition, using a 100 mm VAS (0= completely dissatisfied, 100=completely satisfied)	6 months
Secondary	safety assessment	The safety assessment was based on adverse events reported by the patients during the study and physical findings by the evaluator at each follow-up. The occurrence of adverse events was recorded, including duration, action taken and outcome.	during the study, for 6 months