Knee OsteoarthritisNCT02239029
Platelet Rich Plasma on Osteoarthritis of Knee
A study testing platelet rich plasma and Normal saline in people with Knee Osteoarthritis, run by Yung-Tsan Wu at 1 site in Taiwan.
Trial summary
Although few studies have showed beneficial effect of platelet rich plasma (PRP) for osteoarthritis of knee (OA knee), only one study applied randomized, control method and none of them has the objective measurements such as balance test or muscle strength which were reported as decrease in patients with OA knees. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- platelet rich plasma and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2014to Oct 2016
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 35 to 75 y/o.
- Alert consciousness
- Symptom of knee osteoarthritis persist at least 6 months and stage I or II scored by Ahlbäck grading system
- The pain score measured by VAS at least 4 points
Who cannot join
- Has received hyaluronic acid or steroid injection within 6 monts
- Has received NSAIDs or steroid within one week
- Tumor or metastasis surrounding the knee joint
- Has received total knee replacement, major surgery in knee, rheumatoid arthritis
- Patient who cant tolerance the balance or muscle strength test.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Tri-Service General Hospital, National Defense Medical Center,
Taipei, Neihu District, 886
About this study
Official title: The Effect of Platelet Rich Plasma on Osteoarthritis of Knee
Although few studies have showed beneficial effect of platelet rich plasma (PRP) for osteoarthritis of knee (OA knee), only one study applied randomized, control method and none of them has the objective measurements such as balance test or muscle strength which were reported as decrease in patients with OA knees. We assess the analgesic effect and the extent of improved muscle strength and balance after PRP in patients with OA knee.
Read the detailed description
Patients with bilateral OA knee will be enrolled and randomized into intervention and control knee. One dose of PRP is applied in the intervention knee and normal saline in control side. Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and isokinetic strengthening test at different follow-up frame (2nd week, 1st month, 3rd month and 6th month after treatment).
- Conditions
- Knee Osteoarthritis
- Being tested
- platelet rich plasma, Normal saline
- Keywords
- Platelet rich plasma, Osteoarthritis of knee, Balance, Strength
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasmaDrug
Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders.
Normal salineDrug
The normal salin as the placebo intervention was injection in the other side of knee.
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasma | Active comparator | Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders.
Patients with bilaetral knee osteoarthritis randomized receive on dose of PRP in one knee and placebo with normal saline in the other side. Receives: Drug: platelet rich plasma |
| normal saline | Placebo comparator | Normal saline was injected into the other side of knee as the control group. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of pain on 2nd week, 1st month, 3rd month and 6th month after PRP.
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after PRP.
Secondary outcomes (4)
Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.
Using the Lequesne's severity index to measure the symptoms and functional status before treatment and multiple time frame after treatment.
Measured: Pre-treatment, on 2nd week, 1st month, 3rd month and 6th month after treatment..
Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.
Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to measure the symptoms and functional status before treatment and multiple time frame after treatment.
Measured: Pre-treatment and 2nd week, 1st month, 3rd month and 6th month after treatment.
Change from baseline in balance function on 2nd week, 1st month, 3rd month and 6th month after treatment.
Using the balance test (Biodex) to measure the balance function before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.
Change from baseline in muscle strength of lower extremities on 2nd week, 1st month, 3rd month and 6th month after treatment.
Using the isokinetic strengthening test to measure the muscle strength of lower extremities before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yung-Tsan Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yung-Tsan Wu, Tri-Service General Hospital (TSGH)
- Investigators
- Liang-Cheng Chen, MD, MS, Principal investigator, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239029
- Sponsor's protocol ID
- TSGHIRB-2-103-05-075
- Other IDs
- TSGHIRB-2-103-05-075, Taiwan
- Status last verified
- Dec 2016
- First submitted
- 10 Sep 2014
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Matava MJ. Platelet-rich plasma: the next big thing?: commentary on an article by Ujash Sheth, BHSc, et al.: "Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis". J Bone Joint Surg Am. 2012 Feb 15;94(4):e25. doi: 10.2106/JBJS.K.01423. No abstract available.
PubMed 22241605Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.
PubMed 23299850Spakova T, Rosocha J, Lacko M, Harvanova D, Gharaibeh A. Treatment of knee joint osteoarthritis with autologous platelet-rich plasma in comparison with hyaluronic acid. Am J Phys Med Rehabil. 2012 May;91(5):411-7. doi: 10.1097/PHM.0b013e3182aab72.
PubMed 22513879Khalaj N, Abu Osman NA, Mokhtar AH, Mehdikhani M, Wan Abas WA. Balance and risk of fall in individuals with bilateral mild and moderate knee osteoarthritis. PLoS One. 2014 Mar 18;9(3):e92270. doi: 10.1371/journal.pone.0092270. eCollection 2014.
PubMed 24642715
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platelet Rich Plasma on Osteoarthritis of Knee
- ClinicalTrials.gov ID
- NCT02239029
- Acronym / sponsor ID
- TSGHIRB-2-103-05-075
- Conditions
- Knee Osteoarthritis
- Keywords
- Platelet rich plasma, Osteoarthritis of knee, Balance, Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yung-Tsan WuUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 12 Sep 2014 (estimated)
- 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.
Although few studies have showed beneficial effect of platelet rich plasma (PRP) for osteoarthritis of knee (OA knee), only one study applied randomized, control method and none of them has the objective measurements such as balance test or muscle strength which were reported as decrease in patients with OA knees. We assess the analgesic effect and the extent of improved muscle strength and balance after PRP in patients with OA knee.
Detailed description
Patients with bilateral OA knee will be enrolled and randomized into intervention and control knee. One dose of PRP is applied in the intervention knee and normal saline in control side. Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and isokinetic strengthening test at different follow-up frame (2nd week, 1st month, 3rd month and 6th month after treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasma | Active comparator | Drug: platelet rich plasmaPlatelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders. Patients with bilaetral knee osteoarthritis randomized receive on dose of PRP in one knee and placebo with normal saline in the other side. |
| normal saline | Placebo comparator | Drug: Normal salineNormal saline was injected into the other side of knee as the control group. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 35 to 75 y/o.
- Alert consciousness
- Symptom of knee osteoarthritis persist at least 6 months and stage I or II scored by Ahlbäck grading system
- The pain score measured by VAS at least 4 points
Key exclusion criteria (5 listed)
- Has received hyaluronic acid or steroid injection within 6 monts
- Has received NSAIDs or steroid within one week
- Tumor or metastasis surrounding the knee joint
- Has received total knee replacement, major surgery in knee, rheumatoid arthritis
- Patient who cant tolerance the balance or muscle strength test.
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 |
|---|---|---|
| platelet rich plasmaPlatelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders. | Drug | Platelet rich plasma |
| Normal salineThe normal salin as the placebo intervention was injection in the other side of knee. | Drug | normal saline |
Primary outcome
Change from baseline of pain on 2nd week, 1st month, 3rd month and 6th month after PRP.
Time frame: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after PRP.
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
4 secondary outcomes
Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.
Time frame: Pre-treatment, on 2nd week, 1st month, 3rd month and 6th month after treatment..
Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.
Time frame: Pre-treatment and 2nd week, 1st month, 3rd month and 6th month after treatment.
Change from baseline in balance function on 2nd week, 1st month, 3rd month and 6th month after treatment.
Time frame: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.
Change from baseline in muscle strength of lower extremities on 2nd week, 1st month, 3rd month and 6th month after treatment.
Time frame: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.
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 6 Dec 2016.
- Results publication: PubMed 22241605Matava MJ. Platelet-rich plasma: the next big thing?: commentary on an article by Ujash Sheth, BHSc, et al.: "Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis". J Bone Joint Surg Am. 2012 Feb 15;94(4):e25. doi: 10.2106/JBJS.K.01423. No abstract available.
- Results publication: PubMed 23299850Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.
- Results publication: PubMed 22513879Spakova T, Rosocha J, Lacko M, Harvanova D, Gharaibeh A. Treatment of knee joint osteoarthritis with autologous platelet-rich plasma in comparison with hyaluronic acid. Am J Phys Med Rehabil. 2012 May;91(5):411-7. doi: 10.1097/PHM.0b013e3182aab72.
- Results publication: PubMed 24642715Khalaj N, Abu Osman NA, Mokhtar AH, Mehdikhani M, Wan Abas WA. Balance and risk of fall in individuals with bilateral mild and moderate knee osteoarthritis. PLoS One. 2014 Mar 18;9(3):e92270. doi: 10.1371/journal.pone.0092270. eCollection 2014.
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.
Liang-Cheng Chen, MD, MS principal investigator
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet rich plasma and Normal saline in people with Knee Osteoarthritis, run by Yung-Tsan Wu 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 4 inclusion and 5 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 6 Dec 2016. 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. Some participants in this study may receive a placebo. 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?
Change from baseline of pain on 2nd week, 1st month, 3rd month and 6th month after PRP. (time frame: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after PRP.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02239029, which also lists 4 linked publications.
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 6 Dec 2016.