Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TRB Chemedica AG
ClinicalTrials.gov Identifier:
NCT01482624
First received: November 28, 2011
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

The primary objective of this clinical investigation is to determine whether post-arthroscopic treatment with 10 ml of 0.5% sodium hyaluronate (VISCOSEAL® SYRINGE) can relief pain, improve mobility and promote joint recovery, compared to the standard arthroscopy procedure alone, in patients undergoing arthroscopic procedure.


Condition Intervention
Arthroscopic Meniscal Surgery
Device: Hyaluronan (0.5%, 5 mg/10 ml)
Procedure: Standard arthroscopic meniscal surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery.

Resource links provided by NLM:


Further study details as provided by TRB Chemedica AG:

Primary Outcome Measures:
  • Pain evaluation (ordinal 11-point Likert scale) on day 84. [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain).


Secondary Outcome Measures:
  • Pain evaluation (ordinal 11-point Likert scale) on day of arthroscopy. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain).

  • Pain evaluation (ordinal 11-point Likert scale) on day 14. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain).

  • Pain evaluation (ordinal 11-point Likert scale) on day 42. [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain).

  • Patient's and investigator's global evaluation of study-relevant knee complaints on day 14. [ Time Frame: On Day 14 ] [ Designated as safety issue: No ]
    Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.

  • Patient's and investigator's global evaluation of study-relevant knee complaints on day 42. [ Time Frame: On Day 42 ] [ Designated as safety issue: No ]
    Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.

  • Patient's and investigator's global evaluation of study-relevant knee complaints on day 84. [ Time Frame: On Day 84 ] [ Designated as safety issue: No ]
    Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.

  • Range of Motion at baseline. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Range of Motion of the study relevant knee will be evaluated by a handheld goniometer using the Neutral-0-Method. Measurement unit: degree.

  • Range of Motion on day of arthroscopy. [ Time Frame: On Day 0 ] [ Designated as safety issue: No ]
    Range of Motion of the study relevant knee will be evaluated by a handheld goniometer using the Neutral-0-Method. Measurement unit: degree.

  • Range of Motion on day 14. [ Time Frame: On Day 14 ] [ Designated as safety issue: No ]
    Range of Motion of the study relevant knee will be evaluated by a handheld goniometer using the Neutral-0-Method. Measurement unit: degree.

  • Range of Motion on day 42. [ Time Frame: On Day 42 ] [ Designated as safety issue: No ]
    Range of Motion of the study relevant knee will be evaluated by a handheld goniometer using the Neutral-0-Method. Measurement unit: degree.

  • Range of Motion on day 84. [ Time Frame: On Day 84 ] [ Designated as safety issue: No ]
    Range of Motion of the study relevant knee will be evaluated by a handheld goniometer using the Neutral-0-Method. Measurement unit: degree.

  • Walking ability on day of arthroscopy. [ Time Frame: On Day 0 ] [ Designated as safety issue: No ]

    Patient's walking ability will be evaluated with respect to difficulty on walking 100 metres and pain on walking 100 metres.

    Measured by 5-point scale, ranking from 'none' to 'extreme' difficulty.


  • Walking ability on day 14. [ Time Frame: On Day 14 ] [ Designated as safety issue: No ]

    Patient's walking ability will be evaluated with respect to difficulty on walking 100 metres and pain on walking 100 metres.

    Measured by 5-point scale, ranking from 'none' to 'extreme' difficulty.


  • Walking ability on day 42. [ Time Frame: On Day 42 ] [ Designated as safety issue: No ]

    Patient's walking ability will be evaluated with respect to difficulty on walking 100 metres and pain on walking 100 metres.

    Measured by 5-point scale, ranking from 'none' to 'extreme' difficulty.


  • Walking ability on day 84. [ Time Frame: On Day 84 ] [ Designated as safety issue: No ]

    Patient's walking ability will be evaluated with respect to difficulty on walking 100 metres and pain on walking 100 metres.

    Measured by 5-point scale, ranking from 'none' to 'extreme' difficulty.


  • Health-related quality of life questionnaire at baseline. [ Time Frame: At baseline ] [ Designated as safety issue: No ]

    The descriptive system of health-related quality of life states consists of five dimensions:

    • Mobility,
    • Self-Care,
    • Usual Activities,
    • Pain/Discomfort,
    • Anxiety/Depression.

    The responses record three levels of severity (no problems/some or moderate problems/extreme problems).

    For recording the individual's rating for their current health-related quality of life state, a standard vertical 20 cm visual analogue scale (similar to a thermometer) is utilised.


  • Health-related quality of life questionnaire on day of arthroscopy. [ Time Frame: On day 0 ] [ Designated as safety issue: No ]

    The descriptive system of health-related quality of life states consists of five dimensions:

    • Mobility,
    • Self-Care,
    • Usual Activities,
    • Pain/Discomfort,
    • Anxiety/Depression.

    The responses record three levels of severity (no problems/some or moderate problems/extreme problems).

    For recording the individual's rating for their current health-related quality of life state, a standard vertical 20 cm visual analogue scale (similar to a thermometer) is utilised.


  • Health-related quality of life questionnaire on day 14. [ Time Frame: On day 14 ] [ Designated as safety issue: No ]

    The descriptive system of health-related quality of life states consists of five dimensions:

    • Mobility,
    • Self-Care,
    • Usual Activities,
    • Pain/Discomfort,
    • Anxiety/Depression.

    The responses record three levels of severity (no problems/some or moderate problems/extreme problems).

    For recording the individual's rating for their current health-related quality of life state, a standard vertical 20 cm visual analogue scale (similar to a thermometer) is utilised.


  • Health-related quality of life questionnaire on day 42. [ Time Frame: On day 42 ] [ Designated as safety issue: No ]

    The descriptive system of health-related quality of life states consists of five dimensions:

    • Mobility,
    • Self-Care,
    • Usual Activities,
    • Pain/Discomfort,
    • Anxiety/Depression.

    The responses record three levels of severity (no problems/some or moderate problems/extreme problems).

    For recording the individual's rating for their current health-related quality of life state, a standard vertical 20 cm visual analogue scale (similar to a thermometer) is utilised.


  • Health-related quality of life questionnaire on day 84. [ Time Frame: On day 84 ] [ Designated as safety issue: No ]

    The descriptive system of health-related quality of life states consists of five dimensions:

    • Mobility,
    • Self-Care,
    • Usual Activities,
    • Pain/Discomfort,
    • Anxiety/Depression.

    The responses record three levels of severity (no problems/some or moderate problems/extreme problems).

    For recording the individual's rating for their current health-related quality of life state, a standard vertical 20 cm visual analogue scale (similar to a thermometer) is utilised.


  • Joint Examination Parameters at baseline. [ Time Frame: At baseline ] [ Designated as safety issue: No ]

    Joint Examination comprises

    • Intensity of effusion (measured by 5-point scale, ranking from 'none' to 'extreme' intensity),
    • Necessity of puncture,
    • Clinical parameters: redness, warmth, swelling, tenderness on palpation (measured by 5-point Likert scale, ranging from 'none' to 'extreme' intensity).

  • Joint Examination Parameters on day of arthroscopy. [ Time Frame: On Day 0 ] [ Designated as safety issue: No ]

    Joint Examination comprises

    • Intensity of effusion (measured by 5-point scale, ranking from 'none' to 'extreme' intensity),
    • Necessity of puncture,
    • Clinical parameters: redness, warmth, swelling, tenderness on palpation (measured by 5-point Likert scale, ranging from 'none' to 'extreme' intensity).

  • Joint Examination Parameters on day 14. [ Time Frame: On Day 14 ] [ Designated as safety issue: No ]

    Joint Examination comprises

    • Intensity of effusion (measured by 5-point scale, ranking from 'none' to 'extreme' intensity),
    • Necessity of puncture,
    • Clinical parameters: redness, warmth, swelling, tenderness on palpation (measured by 5-point Likert scale, ranging from 'none' to 'extreme' intensity).

  • Joint Examination Parameters on day 42. [ Time Frame: On Day 42 ] [ Designated as safety issue: No ]

    Joint Examination comprises

    • Intensity of effusion (measured by 5-point scale, ranking from 'none' to 'extreme' intensity),
    • Necessity of puncture,
    • Clinical parameters: redness, warmth, swelling, tenderness on palpation (measured by 5-point Likert scale, ranging from 'none' to 'extreme' intensity).

  • Joint Examination Parameters on day 84. [ Time Frame: On Day 84 ] [ Designated as safety issue: No ]

    Joint Examination comprises

    • Intensity of effusion (measured by 5-point scale, ranking from 'none' to 'extreme' intensity),
    • Necessity of puncture,
    • Clinical parameters: redness, warmth, swelling, tenderness on palpation (measured by 5-point Likert scale, ranging from 'none' to 'extreme' intensity).

  • Frequency of test product-related Adverse Events [ Time Frame: Up to Day 84 ] [ Designated as safety issue: Yes ]
  • Pain evaluation (ordinal 11-point Likert scale) at baseline. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain).

  • Walking ability at baseline. [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    Patient's walking ability will be evaluated with respect to difficulty on walking 100 metres and pain on walking 100 metres.

    Measured by 5-point scale, ranking from 'none' to 'extreme' difficulty.



Enrollment: 64
Study Start Date: December 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VISCOSEAL® SYRINGE Device: Hyaluronan (0.5%, 5 mg/10 ml)
Standard arthroscopic meniscal surgery and add-on treatment with VISCOSEAL® SYRINGE. Single injection of Hyaluronan directly after arthroscopic procedure.
Standard arthroscopic meniscal surgery Procedure: Standard arthroscopic meniscal surgery
Standard arthroscopic meniscal surgery without add-on treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients between 18 and 75 years of age.
  • Good general health condition.
  • Signed written informed consent.
  • Patients with necessity for arthroscopic meniscal surgery.
  • Ensured compliance of subject over the whole study period.

Exclusion Criteria:

  • Concomitant or previous participation in a clinical investigation within the last 3 months prior to study inclusion.
  • Knee joint arthroscopy in study relevant joint within 6 months prior to study inclusion.
  • Patients with known hypersensitivity to the investigational device (i.e. active compound and excipients) or any component or procedure used in the study.
  • Contraindication for the use of the investigational product or for the scheduled arthroscopy, used anesthesia and post-surgical treatment.
  • Concomitant disease of sufficient severity (e.g. uncontrolled diabetes mellitus, carcinoma, etc.), which in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study.
  • Concomitant disease of sufficient severity at study relevant joint (e.g. known or suspected infection, peripheral neuropathy or presence of hemarthros).
  • List of concomitant medications not allowed which interfere with the functional assessments of this study.
  • Use of medication contraindicated for arthroscopic surgery.
  • Intra-articular treatment with a sodium hyaluronate-based product within the last 6 months or use of corticosteroid containing substance within the last 3 months at study relevant joint.
  • Recent history of drug and/or alcohol abuse (within the last 6 months) or patients with severe mental illness or suicidal tendency.
  • Pregnant or lactating females.
  • Participants of childbearing age (pre-menopausal) who do not accept the use of methods of birth control with pearl index ≤ 1% (i.e. oral contraceptives, vaginal ring, hormone-releasing Intrauterine Device (IUD), implants, depot syringes, hormone patch, double barrier method, tubal ligation, vasectomised partner,…) during the treatment period and the first 4 weeks of follow-up period.
  • Subjects having a high probability of non-compliance to the study procedures according to investigator's judgement (like illiteracy, insufficient knowledge of local language).
  • Kellgren III-IV on study relevant side (confirmed by X-ray).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482624

Locations
Belgium
AZ Monica, Orthopedisch centrum SPM
Deurne, Belgium, 2100
Sponsors and Collaborators
TRB Chemedica AG
Investigators
Principal Investigator: Roger van Riet, MD AZ Monica, Orthopedisch centrum SPM, Deurne (Belgium)
  More Information

No publications provided

Responsible Party: TRB Chemedica AG
ClinicalTrials.gov Identifier: NCT01482624     History of Changes
Other Study ID Numbers: VSK-BE-2011-11
Study First Received: November 28, 2011
Last Updated: August 27, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by TRB Chemedica AG:
hyaluronan
hyaluronic acid

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

ClinicalTrials.gov processed this record on April 15, 2014