Knee OsteoarthritisNCT04027738
a Single Intraarticular Injection of PRP for Early Knee OA
A study testing PRP in people with Knee Osteoarthritis, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
This study aimed to investigate the efficacy of a single intraarticular injection of PRP for the treatment of early knee OA. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2017to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine and Rehabilitation, Veterans General Hospital,
Kaohsiung City, 813
About this study
Official title: Efficacy of a Single Intraarticular Injection of Platelet-Rich Plasma for the Treatment of Early Knee Osteoarthritis
This study aimed to investigate the efficacy of a single intraarticular injection of PRP for the treatment of early knee OA.
Read the 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
- Being tested
- PRP
- Keywords
- knee, Osteoarthritis, Platelet rich plasma
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPOther
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 group | Role | What they receive |
|---|---|---|
| PRP injection | Experimental | The patients received a single 3-ml injection of PRP. Receives: Other: PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 6 months
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.
Measured: 6 months
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
Measured: 6 months
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)
Measured: 6 months
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.
Measured: during the study, for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start1 Jan 2017
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical trials with a single arm
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Fen Sun, Kaohsiung Veterans General Hospital.
- Investigators
- Shu Fen Sun, MD, Principal investigator, Kaohsiung Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027738
- Sponsor's protocol ID
- VGHKS106-131
- Status last verified
- Jul 2019
- First submitted
- 18 Jul 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Single Intraarticular Injection of Platelet-Rich Plasma for the Treatment of Early Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04027738
- Acronym / sponsor ID
- VGHKS106-131
- Conditions
- Knee Osteoarthritis
- Keywords
- knee, Osteoarthritis, Platelet rich plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical trials with a single arm
| Arm | Type | Receives |
|---|---|---|
| PRP injection | Experimental | Other: PRPThe patients received a single 3-ml injection of PRP. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRPThe 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. | Other | PRP injection |
Primary outcome
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)
5 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 6 months
Lequesne index
Time frame: 6 months
Single-leg stance test (SLS)
Time frame: 6 months
Patients satisfaction
Time frame: 6 months
safety assessment
Time frame: during the study, for 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu Fen Sun, MD principal investigator
Kaohsiung Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP in people with Knee Osteoarthritis, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.