The primary objective of this study is to evaluate the efficacy and safety of Ostenil application (1% hyaluronan) after arthroscopy of the wrist.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
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 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.
Orthopädische Gemeinschaftspraxis
Straubing, Bavaria, Germany
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)
Time frame: Baseline and 3 months
Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment.
Time frame: Measured during the 6-month duration of participation
Disabilities of the arm, shoulder, and hand (DASH) outcome measure
Time frame: Measured during the 6-month duration of participation
Grip strength
Time frame: Measured during the 6-month duration of participation
Visual analogue scale of pain (VAS; 100 mm)
Time frame: Measured during the 6-month duration of participation
Clinical Global Impression (CGI)
Time frame: 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
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Time frame: Measured during the 6-month duration of participation
Number of subjects with Adverse Events as a measure of safety and tolerability
Time frame: Measured during the 6-month duration of participation