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Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist

NCT01254682 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2011-09-28

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the efficacy and safety of Ostenil application (1% hyaluronan) after arthroscopy of the wrist.

Conditions

  • Arthroscopic Surgery

Interventions

DEVICE

Ostenil

Standard arthroscopy (including intra-articular injection of 5 ml scandicain (0,5%), or 5 ml bupivacain plus 5 ml suprarenin in case of post-arthroscopic treatment). Add-on treatment with Ostenil after standard arthroscopic procedure. Application twice: first injection directly after arthroscopic procedure and second injection 3 weeks post arthroscopic.

PROCEDURE

Standard arthroscopic procedure

Standard arthroscopy (including intra-articular injection of 5 ml scandicain (0,5%), or 5 ml bupivacain plus 5 ml suprarenin in case of post-arthroscopic treatment) without add-on treatment.

Sponsors & Collaborators

  • TRB Chemedica AG

    lead INDUSTRY

Principal Investigators

  • Alexander Schütz, Dr. med. · Orthopädische Gemeinschaftspraxis, Straubing (Germany)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Germany

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 NCT01254682 on ClinicalTrials.gov