NCT01782885

Brief 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. The investigators will evaluate patients outcome in level of pain, knee function and quality of life before the treatment and at 6, 12 and 24 weeks follow up. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
543

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started May 2013

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
4 months until next milestone

Results Posted

Study results publicly available

November 20, 2015

Completed
Last Updated

November 20, 2015

Status Verified

October 1, 2015

Enrollment Period

2.3 years

First QC Date

January 30, 2013

Results QC Date

September 21, 2015

Last Update Submit

October 19, 2015

Conditions

Knee Osteoarthritis

Keywords

OsteoarthritisPlatelet-Rich PlasmaIntra-articularInjection

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    24 weeks

Secondary Outcomes (1)

  • Change in Visual Analog Scale (VAS)

    0-24 weeks

Other Outcomes (4)

  • Change in SF-12v2 Health Survey

    0 weeks

  • Change in SF-12v2 Health Survey

    6 weeks

  • Change in SF-12v2 Health Survey

    12 weeks

  • +1 more other outcomes

Study Arms (2)

Acetaminophen

ACTIVE COMPARATOR

Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) while PRP treatment lasts.

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

Procedure: Intra-articular injection of PRP

Interventions

Intra-articular injection of PRPPROCEDURE

Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks total).

Intra-articular injection of PRP
AcetaminophenDRUG

Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) while PRP treatment lasts (6 weeks total).

Acetaminophen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Dr. José E. González

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (3)

  • 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.

    PMID: 22513879BACKGROUND

  • 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.

    PMID: 22203046BACKGROUND

  • 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.

    PMID: 21856929BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
M Sc Mario Simental-Mendía
Organization
Universidad Autónoma de Nuevo León
mario.simental@gmail.com
+52 (81) 8329 4174

Study Officials

  • Mario A. Simental, MSc

    Universidad Autónoma de Nuevo León, Facultad de Medicina

    PRINCIPAL INVESTIGATOR

  • Felix Vilchez, PhD

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

    STUDY DIRECTOR

  • Herminia G Martínez, PhD

    Universidad Autónoma de Nuevo León, Facultad de Medicina

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M. Sc.

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 4, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 20, 2015

Results First Posted

November 20, 2015

Record last verified: 2015-10

Locations

ME(1)