Clinical trial NCT01482624: Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery
Official title: Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroscopic Meniscal Surgery
Keywords: hyaluronan
hyaluronic acid
Lead sponsor: TRB Chemedica AG
Sponsor class: INDUSTRY
First posted: 2011-11-30
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 procedure.


Eligibility 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).

Primary outcomes:
measure: Pain evaluation (ordinal 11-point Likert scale) on day 84.
timeFrame: Day 84
Secondary outcomes:
measure: Pain evaluation (ordinal 11-point Likert scale) on day of arthroscopy.
timeFrame: Day 0
measure: Pain evaluation (ordinal 11-point Likert scale) on day 14.
timeFrame: Day 14
measure: Pain evaluation (ordinal 11-point Likert scale) on day 42.
timeFrame: Day 42
measure: Patient's and investigator's global evaluation of study-relevant knee complaints on day 14.
timeFrame: On Day 14
measure: Patient's and investigator's global evaluation of study-relevant knee complaints on day 42.
timeFrame: On Day 42
measure: Patient's and investigator's global evaluation of study-relevant knee complaints on day 84.
timeFrame: On Day 84
measure: Range of Motion at baseline.
timeFrame: Baseline
measure: Range of Motion on day of arthroscopy.
timeFrame: On Day 0
measure: Range of Motion on day 14.
timeFrame: On Day 14
measure: Range of Motion on day 42.
timeFrame: On Day 42
measure: Range of Motion on day 84.
timeFrame: On Day 84
measure: Walking ability on day of arthroscopy.
timeFrame: On Day 0
measure: Walking ability on day 14.
timeFrame: On Day 14
measure: Walking ability on day 42.
timeFrame: On Day 42
measure: Walking ability on day 84.
timeFrame: On Day 84
measure: Health-related quality of life questionnaire at baseline.
timeFrame: At baseline
measure: Health-related quality of life questionnaire on day of arthroscopy.
timeFrame: On day 0
measure: Health-related quality of life questionnaire on day 14.
timeFrame: On day 14
measure: Health-related quality of life questionnaire on day 42.
timeFrame: On day 42
measure: Health-related quality of life questionnaire on day 84.
timeFrame: On day 84
measure: Joint Examination Parameters at baseline.
timeFrame: At baseline
measure: Joint Examination Parameters on day of arthroscopy.
timeFrame: On Day 0
measure: Joint Examination Parameters on day 14.
timeFrame: On Day 14
measure: Joint Examination Parameters on day 42.
timeFrame: On Day 42
measure: Joint Examination Parameters on day 84.
timeFrame: On Day 84
measure: Frequency of test product-related Adverse Events
timeFrame: Up to Day 84
measure: Pain evaluation (ordinal 11-point Likert scale) at baseline.
timeFrame: Baseline
measure: Walking ability at baseline.
timeFrame: Baseline
Other outcomes:
Locations:
city: Deurne
country: Belgium
facility: AZ Monica, Orthopedisch centrum SPM
Study officials:
affiliation: AZ Monica, Orthopedisch centrum SPM, Deurne (Belgium)
name: Roger van Riet, MD
role: PRINCIPAL_INVESTIGATOR
References: