NCT07089446

Brief Summary

The purpose of the study is to determine the effects of HA, PRP and the combination of HA and PRP in reducing pain and improving functional disability in patients with knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

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

September 21, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

2.6 years

First QC Date

July 20, 2025

Last Update Submit

July 20, 2025

Conditions

Keywords

Hyaluronic acidosteoarthritispaindisability

Outcome Measures

Primary Outcomes (1)

  • visual analogue scale

    It is a straight line, 100 millimeters long line, one end of the line means "not at all" or "none" and the other end means "the worst possible" or "extremely".

    Recorded before the treatment and repeated within 3 and 6 months after the treatment.

Secondary Outcomes (1)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Recorded before the treatment and repeated within 3 and 6 months after the treatment.

Study Arms (3)

Group A

EXPERIMENTAL

Hyaluronic acid

Drug: Hyaluronic Acid (HA)

Group B

ACTIVE COMPARATOR

platelet rich plasma

Drug: Platelet Rich Plasma

Group C

OTHER

Hyaluronic acid and platelet rich plasma

Drug: Hyaluronic Acid (HA) and Platelet rich plasma

Interventions

Hyaluronic Acid

Group A

Platelet rich plasma

Group B

Hyaluronic Acid and Platelet rich plasma

Group C

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • grade II-III according to the Kellgren-Lawrence classification),
  • pain or functional limitations in patients' activity of daily living before the treatment,
  • age between 40 and 70 years of age, and the absence of clinical or imaging signs of articular instability.

You may not qualify if:

  • includes known hypersensitivity to hyaluronic acid,
  • pregnancy and lactation, a BMI greater than 40 kg/m2,
  • chronic administration of anticoagulant drugs or a history of coagulopathies,
  • neoplastic lesions, and knee or kidney failures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South City Hospital

Karachi, Sindh, 75600, Pakistan

Location

MeSH Terms

Conditions

OsteoarthritisPain

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Basit Ansari, PhD

    University of Karachi

    STUDY CHAIR
  • Ranjeet Kumar, MBBS, FCPS

    University of Karachi

    PRINCIPAL INVESTIGATOR
  • Aftab Ahmed Mirza Baig, PhD

    IQRA University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single blinded study, only the assessor was kept blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly divided into three groups. Twenty cases (Group A) were injected with HA, 20 (Group B) had PRP, and the remaining 20 (Group C) received a combination of HA and PRP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 20, 2025

First Posted

July 28, 2025

Study Start

September 21, 2022

Primary Completion

May 2, 2025

Study Completion

June 15, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Locations