Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist

Study Overview
=================
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.

Official Title
-----------------
Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist

Conditions
-----------------
Arthroscopic Surgery

Intervention / Treatment
-----------------
* Device: Ostenil
* Procedure: Standard arthroscopic procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyaluronic acid sodium salt (1%, 20mg/2ml)<br> | Device: Ostenil<br>* 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.<br>|
| Other: Standard arthroscopic procedure<br> | Procedure: Standard arthroscopic procedure<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wrist, joint, arthroscopy, hyaluronan, hyaluronic acid, Necessity of Arthroscopic surgery