Efficacy of Hyaluronic Acid and Platelet-rich Plasma Combination in Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-14

Study Completion Date

2021-03-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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hyaluronic acid + platelet-rich plasma

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

Group Type EXPERIMENTAL

hyaluronic Acid + platelet-rich plasma

Intervention Type DRUG

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

platelet-rich plasma

Intra-articular injections of platelet-rich plasma

Group Type ACTIVE_COMPARATOR

platelet-rich plasma

Intervention Type DRUG

Intra-articular injections of platelet-rich plasma

hyaluronic acid

Intra-articular injections of hyaluronic acid

Group Type ACTIVE_COMPARATOR

hyaluronic acid

Intervention Type DRUG

Intra-articular injections of hyaluronic acid

Interventions

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hyaluronic Acid + platelet-rich plasma

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

Intervention Type DRUG

hyaluronic acid

Intra-articular injections of hyaluronic acid

Intervention Type DRUG

platelet-rich plasma

Intra-articular injections of platelet-rich plasma

Intervention Type DRUG

Other Intervention Names

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Cellular Matrix/A-CP HA Kit ArthroVisc40 RegenKit-BCT-1

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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;
* Psychiatric disease;
* Pregnancy or breastfeeding.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No