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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on August 27, 2014