NCT06797960

Brief Summary

Randomised controlled trial

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1 knee-osteoarthritis

Timeline
Completed

Started Feb 2025

Shorter than P25 for early_phase_1 knee-osteoarthritis

Status
not yet recruiting

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 21, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

January 21, 2025

Last Update Submit

January 28, 2025

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Pain relief as measured by VAS score

    3 months

Study Arms (2)

PRF group

ACTIVE COMPARATOR
Device: Ultra sound guided Injection of PRF intra articularly

Hyaluronic acid group

ACTIVE COMPARATOR
Drug: Intra articular injection of HA

Interventions

Ultra sound guided Injection of PRF intra articularlyDEVICE

Intra articular injection of PRF

PRF group
Intra articular injection of HADRUG

Intra articular injection of HA

Hyaluronic acid group

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I, II.
  • Moderate knee osteoarthritis

You may not qualify if:

  • Neurological patients.
  • Patients with uncontrolled co morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Islam Shaban Shaban

CONTACT

00201008757498

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 29, 2025

Study Start

February 1, 2025

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

January 29, 2025

Record last verified: 2025-01