Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery

NCT01482624 | Completed

• 1 other identifier: VSK-BE-2011-11
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroscopic Meniscal Surgery

Keywords

hyaluronan; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (28)

• Pain evaluation (ordinal 11-point Likert scale) on day of arthroscopy.

  Day 0

• Pain evaluation (ordinal 11-point Likert scale) on day 14.

  Day 14

• Pain evaluation (ordinal 11-point Likert scale) on day 42.

  Day 42

• Patient's and investigator's global evaluation of study-relevant knee complaints on day 14.

  On Day 14

• Patient's and investigator's global evaluation of study-relevant knee complaints on day 42.

  On Day 42

Study Arms (2)

VISCOSEAL® SYRINGE

ACTIVE COMPARATOR

Device: Hyaluronan (0.5%, 5 mg/10 ml)

Standard arthroscopic meniscal surgery

OTHER

Procedure: Standard arthroscopic meniscal surgery

Interventions

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.

VISCOSEAL® SYRINGE

Standard arthroscopic meniscal surgery PROCEDURE

Standard arthroscopic meniscal surgery without add-on treatment.

Standard arthroscopic meniscal surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• TRB Chemedica AG: lead

Study Sites (1)

AZ Monica, Orthopedisch centrum SPM

Deurne, 2100, Belgium

Location

Study Officials

• Roger van Riet, MD

  AZ Monica, Orthopedisch centrum SPM, Deurne (Belgium)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: November 30, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 28, 2013

Record last verified: 2013-08

Locations

BE (1)