Knee OsteoarthritisNCT01782885

Comparison of Acetaminophen and PRP Therapy for Knee OA

A study testing Intra-articular injection of PRP and Acetaminophen in people with Knee Osteoarthritis, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to test whether the platelet-rich plasma (PRP) intra-articular injection therapy is effective as an alternative treatment option in patients with mild knee osteoarthritis within a controlled randomized study compared to first line treatment acetaminophen. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Intra-articular injection of PRP and Acetaminophen
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 543 participants
Where: 1 siteMexico
Study dates: May 2013to Aug 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Older than 18 years old
Patients who haven't received steroids injection or medical treatment 1 month before the study
Patients with knee osteoarthritis grade I and II (Kellgren-Lawrence scale)
Indistinct gender
Patients who accept to participate in the study with previous signed informed consent

Who cannot join

Patients with knee osteoarthritis grade III and IV (Kellgren-Lawrence scale)
Patients with prosthesis
Pregnancy
Patients with rheumatic diseases
Patients with diabetes, hepatic diseases, coagulopathy, cardiovascular diseases, immunosuppression, infections
Patients taking anticoagulants
Patients with concentrations of hemoglobin under 11 g/dL and platelets under 150,000/uL

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Hospital Universitario Dr. José E. González
Monterrey, Nuevo León, 64460

Other trials in Mexico

About this study

Official title: Comparison of Acetaminophen and Platelet-rich Plasma Therapy for the Treatment of Knee Osteoarthritis.

The study will be complemented with in vitro experiments of human osteoarthritic cartilage explants culture (treated with PRP) for histological and gene expression assays.

PRP intra-articular injections therapy is effective in patients with mild knee osteoarthritis by modifying the biochemical joint environment and cartilage regeneration capability.

Read the detailed description

This is a randomized controled study. Patients enroled in the study will be divided into two groups (calculated n=30 per group). One group will be treated with acetaminophen (500 mg/8 h) for 6 weeks, the experimental group will receive a total of 3 intra-articular injections of PRP, one injection every 2 weeks. The intake of any other analgesic or anti-inflammatory drug will be prohibited in patients from two groups.

For those who received the infiltrations, the procedure consist of a 27-mL venous blood sample in 6 vacutainer tubes with sodium citrate 0.109 M for each injection. Samples are gently agitated to ensure mixing the anticoagulant with the blood. An extra tube with anticoagulated EDTA blood is obtained for initial platelet count. Blood samples are centrifuged for 10 minutes at 1800 rpm to separate the erythrocyte layer. The upper plasma layer is carefully collected in a new sterile propylene tube trying not to remove the leukocyte layer. Plasma from all tubes is centrifuged again for 12 minutes at 3400 rpm to obtain a two-part plasma: the upper part consisting on platelet-poor plasma and lower part consisting of platelet-rich plasma (PRP). The platelet-poor plasma is discarded to obtain a final volume of 3 mL. This volume, consisting of PRP, is mixed carefully through pipetting to resuspend platelets and it was then transferred to a new sterile glass tube. An aliquot of the final PRP is sent to the laboratory for platelet count. All open handling sample procedures are performed within a high-efficiency particulate air-filtered laminar flow hood.

Application of injections is carry out after disinfection of skin in the knee joint area. After local anesthesia with lidocaine chlorohydrate, platelets are activated using 10% calcium gluconate solution and the liquid PRP is injected in a sterile condition using a 22 G needle. The needle is inserted using the superolateral approach in an angle of approximately 45°.

Patients from PRP group will be asked to flex and extend their knees immediately after injection so that PRP could distribute adequately across the joint space. After 5-10 minutes of observation the patients are sent home with written indications including to have relative rest 24 to 48 hours after the injection, the use of cold therapy for 15 minutes three times a day and 500 mg of acetaminophen in case of pain and inflammation.

The use of NSAIDs or any steroids is prohibited. All the patients will be evaluated before the beginning of their respective treatment and at 6, 12 and 24 weeks after. Three different scales are used to evaluate clinical outcome, the VAS (Visual Analog Scale) that scores pain level, the WOMAC (Western Ontario and McMaster Universities Arthritis Index) which assesses pain, articular stiffness and functional limitation, and the Spanish (México) version of the SF-12 (Short Form-12) for assessment of quality of life.

Conditions: Knee Osteoarthritis
Being tested: Intra-articular injection of PRP, Acetaminophen
Keywords: Osteoarthritis, Platelet-Rich Plasma, Intra-articular, Injection
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.

Intra-articular injection of PRPProcedure or surgery
Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks total).
AcetaminophenDrug
Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) while PRP treatment lasts (6 weeks total).

Study groups in NCT01782885
Study group	Role	What they receive
Acetaminophen	Active comparator	Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) while PRP treatment lasts. Receives: Drug: Acetaminophen
Intra-articular injection of PRP	Experimental	Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks Receives: Procedure: Intra-articular injection of PRP

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 0 weeks
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 6 weeks
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 12 weeks
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 24 weeks

Secondary outcomes (1)

Change in Visual Analog Scale (VAS)
The visual analog scale (VAS) is a psychometric response scale which measures subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their current level of pain by indicating a position along a continuous line of 10 cm. Subject is asked: on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, what you rate your current pain?
Measured: 0-24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Aug 2015

First posted4 Feb 2013 (estimated)
Study startMay 2013
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)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: None (open label)
Enrolment: 543 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01782885
Sponsor's protocol ID: BI13-001
Status last verified: Oct 2015
First submitted: 30 Jan 2013
Last updated: 20 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Spakova 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 22513879
Filardo G, Kon E, Pereira Ruiz MT, Vaccaro F, Guitaldi R, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma intra-articular injections for cartilage degeneration and osteoarthritis: single- versus double-spinning approach. Knee Surg Sports Traumatol Arthrosc. 2012 Oct;20(10):2082-91. doi: 10.1007/s00167-011-1837-x. Epub 2011 Dec 28.
PubMed 22203046
van Buul GM, Koevoet WL, Kops N, Bos PK, Verhaar JA, Weinans H, Bernsen MR, van Osch GJ. Platelet-rich plasma releasate inhibits inflammatory processes in osteoarthritic chondrocytes. Am J Sports Med. 2011 Nov;39(11):2362-70. doi: 10.1177/0363546511419278. Epub 2011 Aug 19.
PubMed 21856929

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Acetaminophen and Platelet-rich Plasma Therapy for the Treatment of Knee Osteoarthritis.
ClinicalTrials.gov ID: NCT01782885
Acronym / sponsor ID: BI13-001
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis, Platelet-Rich Plasma, Intra-articular, Injection
Study type: Interventional
Recruitment status: Completed
Enrolment: 543 participants (actual)
Lead sponsor: Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
Study start: May 2013
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 4 Feb 2013 (estimated)
Results: Posted 20 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will be complemented with in vitro experiments of human osteoarthritic cartilage explants culture (treated with PRP) for histological and gene expression assays.

PRP intra-articular injections therapy is effective in patients with mild knee osteoarthritis by modifying the biochemical joint environment and cartilage regeneration capability.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Acetaminophen	Active comparator	Drug: AcetaminophenPatients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) while PRP treatment lasts.
Intra-articular injection of PRP	Experimental	Procedure: Intra-articular injection of PRPPatients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Older than 18 years old
Patients who haven't received steroids injection or medical treatment 1 month before the study
Patients with knee osteoarthritis grade I and II (Kellgren-Lawrence scale)
Indistinct gender
Patients who accept to participate in the study with previous signed informed consent

Key exclusion criteria (7 listed)

Patients with knee osteoarthritis grade III and IV (Kellgren-Lawrence scale)
Patients with prosthesis
Pregnancy
Patients with rheumatic diseases
Patients with diabetes, hepatic diseases, coagulopathy, cardiovascular diseases, immunosuppression, infections

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
Intra-articular injection of PRPPatients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks total).	Procedure or surgery	Intra-articular injection of PRP
AcetaminophenPatients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) while PRP treatment lasts (6 weeks total).	Drug	Acetaminophen

Primary outcome

Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 0 weeks
The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 6 weeks
The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 12 weeks
The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 24 weeks
The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

1 secondary outcome

Change in Visual Analog Scale (VAS)
Time frame: 0-24 weeks

Results and safety

Results posted to the registry on 20 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acetaminophen	36	32
Intra-articular Injection of PRP	39	33

Primary outcome: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Time frame: 0 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Acetaminophen n = 32	Intra-articular Injection of PRP n = 33
Stiffness (0 weeks)	3.0 (2.1)	2.9 (2.0)
Pain (0 weeks)	8.0 (4.3)	7.4 (4.0)
Functional capacity (0 weeks)	24.4 (13.7)	25.3 (14.3)
Total score (0 weeks)	35.5 (19.0)	35.7 (19.5)

Primary outcome: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Time frame: 6 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Acetaminophen n = 32	Intra-articular Injection of PRP n = 33
Stiffness (6 weeks)	2.3 (1.8)	1.1 (1.1)
Pain (6 weeks)	5.8 (2.9)	3.1 (2.6)
Functional capacity (6 weeks)	18.2 (12.0)	8.7 (8.0)
Total score (6 weeks)	26.2 (16.0)	12.8 (11.0)

Primary outcome: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Time frame: 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Acetaminophen n = 32	Intra-articular Injection of PRP n = 33
Stiffness (12 weeks)	2.2 (2.2)	0.9 (1.3)
Pain (12 weeks)	5.7 (4.1)	2.7 (2.4)
Functional capacity (12 weeks)	18.4 (13.1)	8.1 (7.2)
Total score (12 weeks)	26.3 (17.8)	12.0 (10.6)

Primary outcome: Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Time frame: 24 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Acetaminophen n = 32	Intra-articular Injection of PRP n = 33
Stiffness (24 weeks)	1.9 (1.9)	0.8 (1.1)
Pain (24 weeks)	5.3 (3.9)	2.9 (2.2)
Functional capacity (24 weeks)	16.7 (13.3)	7.9 (7.7)
Total score (24 weeks)	23.5 (18.4)	11.7 (10.0)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acetaminophen	0 of 32 (0%)	0 of 32 (0%)	Not reported
Intra-articular Injection of PRP	0 of 33 (0%)	4 of 33 (12.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: 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.
Background: PubMed 22203046Filardo G, Kon E, Pereira Ruiz MT, Vaccaro F, Guitaldi R, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma intra-articular injections for cartilage degeneration and osteoarthritis: single- versus double-spinning approach. Knee Surg Sports Traumatol Arthrosc. 2012 Oct;20(10):2082-91. doi: 10.1007/s00167-011-1837-x. Epub 2011 Dec 28.
Background: PubMed 21856929van Buul GM, Koevoet WL, Kops N, Bos PK, Verhaar JA, Weinans H, Bernsen MR, van Osch GJ. Platelet-rich plasma releasate inhibits inflammatory processes in osteoarthritic chondrocytes. Am J Sports Med. 2011 Nov;39(11):2362-70. doi: 10.1177/0363546511419278. Epub 2011 Aug 19.

Related trials for Knee Osteoarthritis

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Holistic Healing for Knee Osteoarthritis
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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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.

Mario A. Simental, MSc principal investigator

Universidad Autónoma de Nuevo León, Facultad de Medicina

Felix Vilchez, PhD study director

Universidad Autónoma de Nuevo León, Hospital Universitario Dr. José E. González

Herminia G Martínez, PhD study director

Universidad Autónoma de Nuevo León, Facultad de Medicina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intra-articular injection of PRP and Acetaminophen in people with Knee Osteoarthritis, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

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 7 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 20 Nov 2015. 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 Mexico. 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?

Yes. Results are posted in the registry (first posted 20 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: 0 weeks). The study lists 4 primary outcomes in all. 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 NCT01782885, which also lists 3 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 20 Nov 2015.