Clinical trial NCT01254682: Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist
Official title: Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroscopic Surgery
Keywords: wrist
joint
arthroscopy
hyaluronan
hyaluronic acid
Necessity of Arthroscopic surgery
Lead sponsor: TRB Chemedica AG
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment 3 months after arthroscopic surgery.
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment.
timeFrame: Measured during the 6-month duration of participation
measure: Disabilities of the arm, shoulder, and hand (DASH) outcome measure
timeFrame: Measured during the 6-month duration of participation
measure: Grip strength
timeFrame: Measured during the 6-month duration of participation
measure: Visual analogue scale of pain (VAS; 100 mm)
timeFrame: Measured during the 6-month duration of participation
measure: Clinical Global Impression (CGI)
timeFrame: Measured during the 6-month duration of participation
measure: Inter-group comparison of Mayo wrist subscores in subjects with or without post-arthroscopic hyaluronan treatment.
timeFrame: Measured during the 6-month duration of participation
measure: Number of subjects with Adverse Events as a measure of safety and tolerability
timeFrame: Measured during the 6-month duration of participation
Other outcomes:
Locations:
city: Straubing
country: Germany
facility: Orthopädische Gemeinschaftspraxis
state: Bavaria
Study officials:
affiliation: Orthopädische Gemeinschaftspraxis, Straubing (Germany)
name: Alexander Schütz, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: