Treatment of Knee Arthrosis With Platelet-derived Growth Factors vs. Hyaluronic Acid.

Knee Osteoarthrosis Clinical Trial

Official title:

Treatment of Knee Arthrosis: Platelet-derived Growth Factors vs. Hyaluronic Acid. A Phase II-III Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02958761
• Other study ID #: 28914/2009
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2016
• Last updated: November 8, 2016
• Start date: August 2010
• Est. completion date: July 2014

Study information

• Verified date: November 2016
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary aim of this trial was to assess efficacy three intraarticular injections of platelet lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment groups in terms of a number of functional scales and of number of adverse events.

Description:

Intra-articular injections of hyaluronic acid are effective in improving symptoms and slow disease progression, but are not able to revert the damage mechanism and trigger cartilage healing.

Growth factors included in PRP could stimulate cartilage repair, normalize synovial fluid viscoelasticity, induce a correction in tissue damage, improve articular function, control pain and ameliorate quality of life.

Primary aim of this trial was to assess, among patients with grade II/III osteoarthrosis of the knee, efficacy (as determined by improvement at MRI 6 months after the first injection) of three intraarticular injections of platelet lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment groups in terms of a number of functional scales (WOMAC, Lysholm, Tegner Knee, Scale, AKS, Lequesne, VAS) and of number of adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• grade II/III OA of the knee demonstrated at MRI17,18, according to Shahriaree Classification System - modified

• no previous OA treatment with local hyaluronic acid or steroid injections

• ife expectancy >1 year

• no ongoing pregnancy

• ability to understand and complete clinical and functional scales Lysholm, WOMAC, AKS, VAS

• written consent.

Related Conditions & MeSH terms

• Joint Diseases
• Knee Osteoarthrosis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• intraarticular injections of platelet lysate

Drug:
• hyaluronic acid
intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (as determined by improvement at MRI 6 months after the first injection) of intraarticular injections of platelet lysate	Each knee was improvement, from baseline, by at least one degree the maximum MRI score (Shahriaree Classification System - modified) at 6 month	Six months after the last infiltration
Secondary	WOMAC functional scale	multilevel generalized linear models (for panel-data) with interaction between time and treatment group	At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Secondary	Lysholm functional scale	multilevel generalized linear models (for panel-data) with interaction between time and treatment group	At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Secondary	Tegner Knee functional scale	multilevel generalized linear models (for panel-data) with interaction between time and treatment group	At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Secondary	AKS functional scale	multilevel generalized linear models (for panel-data) with interaction between time and treatment group	At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Secondary	Lequesne functional scale	multilevel generalized linear models (for panel-data) with interaction between time and treatment group	At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Secondary	VAS for pain	multilevel generalized linear models (for panel-data) with interaction between time and treatment group	At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Secondary	Adverse event	number of patients and knees with adverse event (any); anticipated potential adverse events were infection, anaphylaxis, hematoma	1 year