Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist

TRB Chemedica

Status: Completed

Conditions: Arthroscopic Surgery

Treatments: Device: Ostenil; Procedure: Standard arthroscopic procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254682

OSTWA-07-01

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Hyaluronic acid sodium salt (1%, 20mg/2ml)

Active Comparator group

Treatment:

Device: Ostenil

Standard arthroscopic procedure

Other group

Treatment:

Procedure: Standard arthroscopic procedure