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Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist

NCT ID: NCT01254682

Last Updated: 2011-09-28

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

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-08-31

Brief Summary

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

Detailed Description

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Conditions

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Arthroscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyaluronic acid sodium salt (1%, 20mg/2ml)

Group Type ACTIVE_COMPARATOR

Ostenil

Intervention Type DEVICE

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.

Standard arthroscopic procedure

Group Type OTHER

Standard arthroscopic procedure

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male and female patients between 18 and 80 years of age
* Minimum pain score of 2 according to modified Mayo Wrist Score
* Patients in good general health/nutritional condition
* Signed written informed consent

Exclusion Criteria

* Alcohol / drug abuse, drug addiction or neurotic personality disorder; patients with mental illness or suicidal tendency
* Severe intercurrent illness (like uncontrolled diabetes mellitus or thyroid disease, carcinoma,...)
* Fertile women without medically secured contraception(hysterectomy, sterilization, contraceptives,...)
* Subjects having a high probability of non compliance to the study procedures according to investigator's judgement (like illiteracy, insufficient German linguistic knowledge)
* Contraindication for the use of one of the investigational products or for the scheduled anesthesia
* Concomitant or previous participation in a clinical trial within the last 3 months
* Intraarticular treatment with a sodium hyaluronate-based product within the last 6 months
* Intraarticular treatment by the use of corticoid containing substance within the last 3 months
* Concomitant illness or injury influencing study evaluation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TRB Chemedica AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Schütz, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Orthopädische Gemeinschaftspraxis, Straubing (Germany)

Locations

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Orthopädische Gemeinschaftspraxis

Straubing, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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OSTWA-07-01

Identifier Type: -

Identifier Source: org_study_id