NCT06408922

Brief Summary

80 patients diagnosed with knee osteoarthritis were randomized into two groups: patients in Group 1 received a single intraarticular injection of PRP whereas those in group 2 were administered three intraarticular injections of PRP within an interval of 2 weeks between each application. Patients were evaluated before the treatment and at the 6 month after the treatment with a Visual Analog Scale (VAS) and The Western Ontario and MacMaster Universities (WOMAC) Osteoarthritis Index.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2023

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

Study Start

First participant enrolled

April 15, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

12 months

First QC Date

May 7, 2024

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Western Ontario and MacMaster Universities (WOMAC) Osteoarthritis Index

    baseline and 6 months

Secondary Outcomes (1)

  • Visual Analog Scale (VAS)

    baseline and 6 months

Study Arms (2)

Single prp injection

ACTIVE COMPARATOR

single intraarticular prp injection

Other: prp injection

triple prp injection

ACTIVE COMPARATOR

triple intraarticular prp injection

Other: prp injection

Interventions

intraarticular prp

Single prp injectiontriple prp injection

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ages of 35 and 80
  • Kellgren-Lawrence grade of 2, 3, or 4

You may not qualify if:

  • rheumatic diseases, coagulopathies, severe cardiovascular diseases, local infections, malignancies, immunodeficiency, schizophrenia, mental retardation, anticoagulant therapy, a hemoglobin concentration of 11 g/dL and platelets of 150,000/L, a history of severe trauma, or a history of hyaluronic acid or corticosteroid injection within the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buca Seyfi Demirsoy Training and Research Hospital

Izmir, 35000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Pituitary Adenylate Cyclase-Activating Polypeptide

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Nerve Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsNeuropeptidesProteinsNerve Tissue ProteinsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 10, 2024

Study Start

April 15, 2023

Primary Completion

April 1, 2024

Study Completion

April 15, 2024

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations