Arthroscopic Surgery
Conditions
Keywords
wrist, joint, arthroscopy, hyaluronan, hyaluronic acid, Necessity of Arthroscopic surgery
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.
Interventions
DEVICEOstenil
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.
PROCEDUREStandard 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.
Sponsors
TRB Chemedica AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| 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 | — |
| Clinical Global Impression (CGI) | Measured during the 6-month duration of participation | — |
Countries
Germany
Outcome results
None listed