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Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery

NCT01482624 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2013-08-28

No results posted yet for this study

Summary

The primary objective of this clinical investigation is to determine whether post-arthroscopic treatment with 10 ml of 0.5% sodium hyaluronate (VISCOSEAL® SYRINGE) can relief pain, improve mobility and promote joint recovery, compared to the standard arthroscopy procedure alone, in patients undergoing arthroscopic procedure.

Conditions

  • Arthroscopic Meniscal Surgery

Interventions

DEVICE

Hyaluronan (0.5%, 5 mg/10 ml)

Standard arthroscopic meniscal surgery and add-on treatment with VISCOSEAL® SYRINGE. Single injection of Hyaluronan directly after arthroscopic procedure.

PROCEDURE

Standard arthroscopic meniscal surgery

Standard arthroscopic meniscal surgery without add-on treatment.

Sponsors & Collaborators

  • TRB Chemedica AG

    lead INDUSTRY

Principal Investigators

  • Roger van Riet, MD · AZ Monica, Orthopedisch centrum SPM, Deurne (Belgium)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01482624 on ClinicalTrials.gov