Arthroscopic Meniscal SurgeryNCT01482624
Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery
A study testing Hyaluronan (0.5%, 5 mg/10 ml) and Standard arthroscopic meniscal surgery in people with Arthroscopic Meniscal Surgery, run by TRB Chemedica AG at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthroscopic Meniscal Surgery
- What is being tested?
- Hyaluronan (0.5%, 5 mg/10 ml) and Standard arthroscopic meniscal surgery
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Arthroscopic Meniscal Surgery
- Being tested
- Hyaluronan (0.5%, 5 mg/10 ml), Standard arthroscopic meniscal surgery
- Keywords
- hyaluronan, hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronan (0.5%, 5 mg/10 ml)Device
Standard arthroscopic meniscal surgery and add-on treatment with VISCOSEAL® SYRINGE. Single injection of Hyaluronan directly after arthroscopic procedure.
Standard arthroscopic meniscal surgeryProcedure or surgery
Standard arthroscopic meniscal surgery without add-on treatment.
| Study group | Role | What they receive |
|---|---|---|
| VISCOSEAL® SYRINGE | Active comparator | Not described Receives: Device: Hyaluronan (0.5%, 5 mg/10 ml) |
| Standard arthroscopic meniscal surgery | Other | Not described Receives: Procedure: Standard arthroscopic meniscal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 84
Secondary outcomes (28)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: On Day 84
Frequency of test product-related Adverse Events
Measured: 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).
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Meniscal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- TRB Chemedica AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger van Riet, MD, Principal investigator, AZ Monica, Orthopedisch centrum SPM, Deurne (Belgium)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482624
- Sponsor's protocol ID
- VSK-BE-2011-11
- Status last verified
- Aug 2013
- First submitted
- 28 Nov 2011
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery.
- ClinicalTrials.gov ID
- NCT01482624
- Acronym / sponsor ID
- VSK-BE-2011-11
- Conditions
- Arthroscopic Meniscal Surgery
- Keywords
- hyaluronan, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- TRB Chemedica AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VISCOSEAL® SYRINGE | Active comparator | Device: Hyaluronan (0.5%, 5 mg/10 ml) |
| Standard arthroscopic meniscal surgery | Other | Procedure: Standard arthroscopic meniscal surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | VISCOSEAL® SYRINGE |
| Standard arthroscopic meniscal surgeryStandard arthroscopic meniscal surgery without add-on treatment. | Procedure or surgery | Standard arthroscopic meniscal surgery |
Primary outcome
Pain evaluation (ordinal 11-point Likert scale) on day 84.
Time frame: Day 84
Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain).
28 secondary outcomes
Pain evaluation (ordinal 11-point Likert scale) on day of arthroscopy.
Time frame: Day 0
Pain evaluation (ordinal 11-point Likert scale) on day 14.
Time frame: Day 14
Pain evaluation (ordinal 11-point Likert scale) on day 42.
Time frame: Day 42
Patient's and investigator's global evaluation of study-relevant knee complaints on day 14.
Time frame: On Day 14
Patient's and investigator's global evaluation of study-relevant knee complaints on day 42.
Time frame: On Day 42
Patient's and investigator's global evaluation of study-relevant knee complaints on day 84.
Time frame: On Day 84
Range of Motion at baseline.
Time frame: Baseline
Range of Motion on day of arthroscopy.
Time frame: On Day 0
Range of Motion on day 14.
Time frame: On Day 14
Range of Motion on day 42.
Time frame: On Day 42
Range of Motion on day 84.
Time frame: On Day 84
Walking ability on day of arthroscopy.
Time frame: On Day 0
Walking ability on day 14.
Time frame: On Day 14
Walking ability on day 42.
Time frame: On Day 42
Walking ability on day 84.
Time frame: On Day 84
Health-related quality of life questionnaire at baseline.
Time frame: At baseline
Health-related quality of life questionnaire on day of arthroscopy.
Time frame: On day 0
Health-related quality of life questionnaire on day 14.
Time frame: On day 14
Health-related quality of life questionnaire on day 42.
Time frame: On day 42
Health-related quality of life questionnaire on day 84.
Time frame: On day 84
Joint Examination Parameters at baseline.
Time frame: At baseline
Joint Examination Parameters on day of arthroscopy.
Time frame: On Day 0
Joint Examination Parameters on day 14.
Time frame: On Day 14
Joint Examination Parameters on day 42.
Time frame: On Day 42
Joint Examination Parameters on day 84.
Time frame: On Day 84
Frequency of test product-related Adverse Events
Time frame: Up to Day 84
Pain evaluation (ordinal 11-point Likert scale) at baseline.
Time frame: Baseline
Walking ability at baseline.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger van Riet, MD principal investigator
AZ Monica, Orthopedisch centrum SPM, Deurne (Belgium)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronan (0.5%, 5 mg/10 ml) and Standard arthroscopic meniscal surgery in people with Arthroscopic Meniscal Surgery, run by TRB Chemedica AG at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain evaluation (ordinal 11-point Likert scale) on day 84. (time frame: Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013.