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Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TRB Chemedica AG
ClinicalTrials.gov Identifier:
NCT01254682
First received: November 22, 2010
Last updated: September 27, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition Intervention
Arthroscopic Surgery
 Device: Ostenil
Procedure: Standard arthroscopic procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by TRB Chemedica AG:

Primary Outcome Measures:
  • Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment 3 months after arthroscopic surgery. [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Disabilities of the arm, shoulder, and hand (DASH) outcome measure [ Time Frame: Measured during the 6-month duration of participation ] [ Designated as safety issue: No ]
  • Grip strength [ Time Frame: Measured during the 6-month duration of participation ] [ Designated as safety issue: No ]
  • Visual analogue scale of pain (VAS; 100 mm) [ Time Frame: Measured during the 6-month duration of participation ] [ Designated as safety issue: No ]
  • Clinical Global Impression (CGI) [ Time Frame: Measured during the 6-month duration of participation ] [ Designated as safety issue: No ]
  • Inter-group comparison of Mayo wrist subscores in subjects with or without post-arthroscopic hyaluronan treatment. [ Time Frame: Measured during the 6-month duration of participation ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: Measured during the 6-month duration of participation ] [ Designated as safety issue: Yes ]

Enrollment: 140
Study Start Date: January 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hyaluronic acid sodium salt (1%, 20mg/2ml) 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.
Standard arthroscopic procedure 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254682

Locations
Germany
Orthopädische Gemeinschaftspraxis
Straubing, Bavaria, Germany, 94315
Sponsors and Collaborators
TRB Chemedica AG
Investigators
Principal Investigator: Alexander Schütz, Dr. med. Orthopädische Gemeinschaftspraxis, Straubing (Germany)
  More Information

No publications provided

Responsible Party: TRB Chemedica AG
ClinicalTrials.gov Identifier: NCT01254682     History of Changes
Other Study ID Numbers: OSTWA-07-01
Study First Received: November 22, 2010
Last Updated: September 27, 2011
Health Authority: Germany: Government of Upper Bavaria (Regierung von Oberbayern)

Keywords provided by TRB Chemedica AG:
wrist
joint
arthroscopy
 hyaluronan
hyaluronic acid
Necessity of Arthroscopic surgery

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013