NCT05039463

Brief Summary

The French Society of Rheumatology cannot rule on the value of intra-articular injections of PRP due to the lack of hindsight and insufficient data. In fact, the injection protocols are very heterogeneous in terms of preparation method, the presence or not of leukocytes, the number of centrifugations, the volume injected, the ultrasound guidance, which makes it difficult to analyze the literature. The investigator objective is therefore to evaluate the effectiveness of combined injections of PRP and hyaluronic acid.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

August 31, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 31, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

August 31, 2021

Last Update Submit

February 7, 2023

Conditions

Knee OsteoarthritisHyaluronic AcidPlatelet Rich Plasma

Keywords

platelet rich plasmahyaluronic acidKnee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • change of the visual analogue scale (VAS) from the "PRP + HA" group on the "HA alone" group

    up to one year

Study Arms (2)

PRP + HA

two injections of PRP (plasma rich in platelets ), in combination with HA (hyaluronic acid)

HA alone

HA (hyaluronic acid)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients benefiting, in the context of knee osteoarthritis, from viscosupplementation alone or from two injections of PRP, in combination with HA, at the Amiens University Hospital.

You may qualify if:

  • age : \> 18 years old
  • Patients benefiting, in the context of knee osteoarthritis, from viscosupplementation alone or from two injections of PRP, in combination with HA, at the Amiens University Hospital.

You may not qualify if:

  • Patient refusal to use the data
  • Language barrier
  • Age less than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

LAURE LE MONNIER, MD

CONTACT

03 22 66 82 50lemonnier.laure@chu-amiens.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 9, 2021

Study Start

August 31, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)