Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery

Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery.

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.

Study Overview

• Status: Completed
• Conditions: Arthroscopic Meniscal Surgery
• Intervention / Treatment: Device: Hyaluronan (0.5%, 5 mg/10 ml); Procedure: Standard arthroscopic meniscal surgery

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Deurne, Belgium, 2100
    • AZ Monica, Orthopedisch centrum SPM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
OTHER: Standard arthroscopic meniscal surgery	Procedure: Standard arthroscopic meniscal surgery; Standard arthroscopic meniscal surgery without add-on treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain evaluation (ordinal 11-point Likert scale) on day 84.	Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain).	Day 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain evaluation (ordinal 11-point Likert scale) on day of arthroscopy.	Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain).	Day 0
Pain evaluation (ordinal 11-point Likert scale) on day 14.	Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain).	Day 14
Pain evaluation (ordinal 11-point Likert scale) on day 42.	Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain).	Day 42
Patient's and investigator's global evaluation of study-relevant knee complaints on day 14.	Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.	On Day 14
Patient's and investigator's global evaluation of study-relevant knee complaints on day 42.	Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.	On Day 42
Patient's and investigator's global evaluation of study-relevant knee complaints on day 84.	Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.	On Day 84
Range of Motion at baseline.	Range of Motion of the study relevant knee will be evaluated by a handheld goniometer using the Neutral-0-Method. Measurement unit: degree.	Baseline
Range of Motion on day of arthroscopy.	Range of Motion of the study relevant knee will be evaluated by a handheld goniometer using the Neutral-0-Method. Measurement unit: degree.	On Day 0
Range of Motion on day 14.	Range of Motion of the study relevant knee will be evaluated by a handheld goniometer using the Neutral-0-Method. Measurement unit: degree.	On Day 14
Range of Motion on day 42.	Range of Motion of the study relevant knee will be evaluated by a handheld goniometer using the Neutral-0-Method. Measurement unit: degree.	On Day 42
Range of Motion on day 84.	Range of Motion of the study relevant knee will be evaluated by a handheld goniometer using the Neutral-0-Method. Measurement unit: degree.	On Day 84
Walking ability on day of arthroscopy.	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.	On Day 0
Walking ability on day 14.	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.	On Day 14
Walking ability on day 42.	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.	On Day 42
Walking ability on day 84.	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.	On Day 84
Health-related quality of life questionnaire at baseline.	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.	At baseline
Health-related quality of life questionnaire on day of arthroscopy.	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.	On day 0
Health-related quality of life questionnaire on day 14.	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.	On day 14
Health-related quality of life questionnaire on day 42.	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.	On day 42
Health-related quality of life questionnaire on day 84.	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.	On day 84
Joint Examination Parameters at baseline.	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).	At baseline
Joint Examination Parameters on day of arthroscopy.	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).	On Day 0
Joint Examination Parameters on day 14.	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).	On Day 14
Joint Examination Parameters on day 42.	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).	On Day 42
Joint Examination Parameters on day 84.	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).	On Day 84
Frequency of test product-related Adverse Events		Up to Day 84
Pain evaluation (ordinal 11-point Likert scale) at baseline.	Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain).	Baseline
Walking ability at baseline.	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.	Baseline

Collaborators and Investigators

• Sponsor: TRB Chemedica AG
• Investigators: Principal Investigator: Roger van Riet, MD, AZ Monica, Orthopedisch centrum SPM, Deurne (Belgium)

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: November 28, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (ESTIMATE): November 30, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 28, 2013
• Last Update Submitted That Met QC Criteria: August 27, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: hyaluronic acid; hyaluronan
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: VSK-BE-2011-11