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出境医 / 临床实验 / a Single Intraarticular Injection of PRP for Early Knee OA
a Single Intraarticular Injection of PRP for Early Knee OA
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Knee Osteoarthritis | Other: PRP | Not Applicable |
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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 41 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Clinical trials with a single arm |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy of a Single Intraarticular Injection of Platelet-Rich Plasma for the Treatment of Early Knee Osteoarthritis |
| Actual Study Start Date : | January 1, 2017 |
| Actual Primary Completion Date : | December 30, 2017 |
| Actual Study Completion Date : | December 30, 2017 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: PRP injection
The patients received a single 3-ml injection of PRP.
|
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.
|
Outcome Measures
Primary Outcome Measures :
- VAS pain [ Time Frame: 6 months ]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) [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]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) [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]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 [ Time Frame: during the study, for 6 months ]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.
Eligibility Criteria
| Ages Eligible for Study: | 20 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Locations
| Taiwan | |
| Department of Physical Medicine and Rehabilitation, Veterans General Hospital, | |
| Kaohsiung, Taiwan, 813 | |
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
| Principal Investigator: | Shu Fen Sun, MD | Kaohsiung Veterans General Hospital, Taiwan |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 18, 2019 | ||||
| First Posted Date ICMJE | July 22, 2019 | ||||
| Last Update Posted Date | July 22, 2019 | ||||
| Actual Study Start Date ICMJE | January 1, 2017 | ||||
| Actual Primary Completion Date | December 30, 2017 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
VAS pain [ Time Frame: 6 months ] 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)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | a Single Intraarticular Injection of PRP for Early Knee OA | ||||
| Official Title ICMJE | Efficacy of a Single Intraarticular Injection of Platelet-Rich Plasma for the Treatment of Early Knee Osteoarthritis | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Clinical trials with a single arm Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE | Knee Osteoarthritis | ||||
| Intervention ICMJE | 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.
|
||||
| Study Arms ICMJE | Experimental: PRP injection
The patients received a single 3-ml injection of PRP.
Intervention: Other: PRP
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
41 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | December 30, 2017 | ||||
| Actual Primary Completion Date | December 30, 2017 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Taiwan | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04027738 | ||||
| Other Study ID Numbers ICMJE | VGHKS106-131 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Shu-Fen Sun, Kaohsiung Veterans General Hospital. | ||||
| Study Sponsor ICMJE | Kaohsiung Veterans General Hospital. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Kaohsiung Veterans General Hospital. | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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