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Completed

NCT Number: NCT01254682

Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist

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

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Key information

Conditions

Arthroscopic Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopädische Gemeinschaftspraxis

Straubing, Bavaria, 94315, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ostenil

Device

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 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.

Primary outcomes

  1. 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

    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 outcomes

  1. 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

  2. Disabilities of the arm, shoulder, and hand (DASH) outcome measure

    Time frame: Measured during the 6-month duration of participation

  3. Grip strength

    Time frame: Measured during the 6-month duration of participation

  4. Visual analogue scale of pain (VAS; 100 mm)

    Time frame: Measured during the 6-month duration of participation

  5. Clinical Global Impression (CGI)

    Time frame: Measured during the 6-month duration of participation

  6. 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

    • Maximal grip strength on injured side (compared to contralateral side)
    • Range of motion
    • Pain
    • Function in daily activities

  7. Number of subjects with Adverse Events as a measure of safety and tolerability

    Time frame: Measured during the 6-month duration of participation

Sponsors and collaborators

Lead sponsor

TRB Chemedica AG

Industry

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 6, 2010
Registry last updated
Sep 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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