Back to resultsa Single Intraarticular Injection of PRP for Early Knee OA
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PRP
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee, Osteoarthritis, Platelet rich plasma
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.
Sites / Locations
- Department of Physical Medicine and Rehabilitation, Veterans General Hospital,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PRP injection
Arm Description
The patients received a single 3-ml injection of PRP.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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.
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
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)
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.
Full Information
NCT ID
NCT04027738
First Posted
July 18, 2019
Last Updated
July 18, 2019
Sponsor
Kaohsiung Veterans General Hospital.
1. Study Identification
Unique Protocol Identification Number
NCT04027738
Brief Title
a Single Intraarticular Injection of PRP for Early Knee OA
Official Title
Efficacy of a Single Intraarticular Injection of Platelet-Rich Plasma for the Treatment of Early Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee, Osteoarthritis, Platelet rich plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Clinical trials with a single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRP injection
Arm Type
Experimental
Arm Description
The patients received a single 3-ml injection of PRP.
Intervention Type
Other
Intervention Name(s)
PRP
Intervention Description
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.
Primary Outcome Measure Information:
Title
VAS pain
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
6 months
Title
Lequesne index
Description
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.
Time Frame
6 months
Title
Single-leg stance test (SLS)
Description
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
Time Frame
6 months
Title
Patients satisfaction
Description
Patients were asked to rate their treatment satisfaction compared to the preinjection condition, using a 100 mm VAS (0= completely dissatisfied, 100=completely satisfied)
Time Frame
6 months
Title
safety assessment
Description
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.
Time Frame
during the study, for 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu Fen Sun, MD
Organizational Affiliation
Kaohsiung Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Veterans General Hospital,
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
12. IPD Sharing Statement
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a Single Intraarticular Injection of PRP for Early Knee OA
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