Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist

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

Study Overview

• Status: Completed
• Conditions: Arthroscopic Surgery
• Intervention / Treatment: Device: Ostenil; Procedure: Standard arthroscopic procedure

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Straubing, Bavaria, Germany, 94315
      • Orthopädische Gemeinschaftspraxis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hyaluronic acid sodium salt (1%, 20mg/2ml)	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.
Other: Standard arthroscopic procedure	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment 3 months after arthroscopic surgery.	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)	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Maximal grip strength on injured side (compared to contralateral side); Range of motion; Pain; Function in daily activities	Measured during the 6-month duration of participation
Number of subjects with Adverse Events as a measure of safety and tolerability		Measured during the 6-month duration of participation

Collaborators and Investigators

• Sponsor: TRB Chemedica AG
• Investigators: Principal Investigator: Alexander Schütz, Dr. med., Orthopädische Gemeinschaftspraxis, Straubing (Germany)

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: November 22, 2010
• First Submitted That Met QC Criteria: December 3, 2010
• First Posted (Estimate): December 6, 2010

Study Record Updates

• Last Update Posted (Estimate): September 28, 2011
• Last Update Submitted That Met QC Criteria: September 27, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: arthroscopy; joint; wrist; hyaluronic acid; hyaluronan; Necessity of Arthroscopic surgery
• Other Study ID Numbers: OSTWA-07-01