Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist

Arthroscopic Surgery Clinical Trial

Official title:

Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254682
• Other study ID #: OSTWA-07-01
• Status: Completed
• Phase: N/A
• First received: November 22, 2010
• Last updated: September 27, 2011
• Start date: January 2007
• Est. completion date: August 2009

Study information

• Verified date: September 2011
• Source: TRB Chemedica AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Government of Upper Bavaria (Regierung von Oberbayern)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroscopic Surgery

Intervention

Device:
• Ostenil
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.

Procedure:
• Standard 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.

Locations

Country	Name	City	State
Germany	Orthopädische Gemeinschaftspraxis	Straubing	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
TRB Chemedica AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Disabilities of the arm, shoulder, and hand (DASH) outcome measure		Measured during the 6-month duration of participation	No
Secondary	Grip strength		Measured during the 6-month duration of participation	No
Secondary	Visual analogue scale of pain (VAS; 100 mm)		Measured during the 6-month duration of participation	No
Secondary	Clinical Global Impression (CGI)		Measured during the 6-month duration of participation	No
Secondary	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	No
Secondary	Number of subjects with Adverse Events as a measure of safety and tolerability		Measured during the 6-month duration of participation	Yes