NCT03211650

Brief Summary

The purpose of this study is to evaluate the efficacy of intra-articular injections of combined hyaluronic acid and platelet-rich plasma in knee degenerative joint disease in improving joint function and reducing pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P75+ for phase_4 knee-osteoarthritis

Timeline
Completed

Started Oct 2016

Longer than P75 for phase_4 knee-osteoarthritis

Geographic Reach
1 country

2 active sites

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

October 14, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2021

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

2.1 years

First QC Date

July 6, 2017

Last Update Submit

June 10, 2021

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • WOMAC score

    Comparison of WOMAC total score among three treatment arms

    6 months after the first intra-articular injection

Study Arms (3)

hyaluronic acid + platelet-rich plasma

EXPERIMENTAL

Intra-articular injections of hyaluronic acid combined with platelet-rich plasma

Drug: hyaluronic Acid + platelet-rich plasma

platelet-rich plasma

ACTIVE COMPARATOR

Intra-articular injections of platelet-rich plasma

Drug: platelet-rich plasma

hyaluronic acid

ACTIVE COMPARATOR

Intra-articular injections of hyaluronic acid

Drug: hyaluronic acid

Interventions

hyaluronic Acid + platelet-rich plasmaDRUG

Intra-articular injections of hyaluronic acid combined with platelet-rich plasma

Also known as: Cellular Matrix/A-CP HA Kit
hyaluronic acid + platelet-rich plasma
hyaluronic acidDRUG

Intra-articular injections of hyaluronic acid

Also known as: ArthroVisc40
hyaluronic acid
platelet-rich plasmaDRUG

Intra-articular injections of platelet-rich plasma

Also known as: RegenKit-BCT-1
platelet-rich plasma

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee pain for 4 months;
  • Knee degenerative sign evaluated with X-ray with a Kellgren-Lawrence grade inferior to 3;
  • Patients able to understand the study conditions and willing to participate for its entire duration;
  • Patients who signed written informed consent.

You may not qualify if:

  • Severe knee osteoarthritis of grade 4;
  • Diabetes mellitus;
  • Rheumatoid arthritis;
  • Ongoing malignancies;
  • Certified allergic reactions towards the administered drugs ;
  • Malalignment of mechanical axis of the lower limb (varus \> 10 °, valgus \> 10 °);
  • Coagulopathies;
  • Severe cardiovascular diseases;
  • Ongoing infections;
  • Immunodepression;
  • Anticoagulants or anti-platelet agents;
  • Haemoglobin \< 11 g/dl;
  • Platelet count \< 150,000/mm\^3
  • Drug addiction;
  • Alcoholism;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

Milan, Milan, 20122, Italy

Location

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Pietro Randelli, Professor

    Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

July 6, 2017

First Posted

July 7, 2017

Study Start

October 14, 2016

Primary Completion

November 30, 2018

Study Completion

March 27, 2021

Last Updated

June 14, 2021

Record last verified: 2021-06

Locations

IT(2)