Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist

Not Applicable

Completed

• Conditions: Arthroscopic Surgery
• Interventions: Device: Ostenil; Procedure: Standard arthroscopic procedure

• Registration Number: NCT01254682
• Lead Sponsor: TRB Chemedica AG

Brief Summary

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

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-06
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-27
• Last Update Posted: 2011-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid sodium salt (1%, 20mg/2ml)	Ostenil	-
Standard arthroscopic procedure	Standard arthroscopic procedure	-

Primary Outcome Measures

Name	Time	Method
Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment 3 months after arthroscopic surgery.	Baseline and 3 months	Mayo wrist score evaluation consisting of 4 sections: * Maximal grip strength on injured side (compared to maximal strength of contralateral side, measured by 4-point scale, ranking from '0' for minimal to '30' for maximal strength); * Range of motion (measured by 4-point scale, ranking from '0' for minimal to '20' for maximal mobility); * Pain (measured by 4-point scale, ranking from '0' for maximal to '20' for minimal pain); * Function in daily activities (measured by 4-point scale, ranking from '0' for minimal to '30' for maximal function)

Secondary Outcome Measures

Name	Time	Method
Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment.	Measured during the 6-month duration of participation
Disabilities of the arm, shoulder, and hand (DASH) outcome measure	Measured during the 6-month duration of participation
Grip strength	Measured during the 6-month duration of participation
Visual analogue scale of pain (VAS; 100 mm)	Measured during the 6-month duration of participation
Clinical Global Impression (CGI)	Measured during the 6-month duration of participation
Inter-group comparison of Mayo wrist subscores in subjects with or without post-arthroscopic hyaluronan treatment.	Measured during the 6-month duration of participation	* Maximal grip strength on injured side (compared to contralateral side); * Range of motion; * Pain; * Function in daily activities
Number of subjects with Adverse Events as a measure of safety and tolerability	Measured during the 6-month duration of participation

Trial Locations

Locations (1)

Orthopädische Gemeinschaftspraxis; 🇩🇪 Straubing, Bavaria, Germany