Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery

NCT ID: NCT01482624

Last Updated: 2013-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VISCOSEAL® SYRINGE

Group Type: ACTIVE_COMPARATOR

Hyaluronan (0.5%, 5 mg/10 ml)

Intervention Type: DEVICE

Standard arthroscopic meniscal surgery and add-on treatment with VISCOSEAL® SYRINGE. Single injection of Hyaluronan directly after arthroscopic procedure.

Standard arthroscopic meniscal surgery

Group Type: OTHER

Standard arthroscopic meniscal surgery

Intervention Type: PROCEDURE

Standard arthroscopic meniscal surgery without add-on treatment.

Interventions

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.

Intervention Type: DEVICE

Standard arthroscopic meniscal surgery

Standard arthroscopic meniscal surgery without add-on treatment.

Intervention Type: 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TRB Chemedica AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger van Riet, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Monica, Orthopedisch centrum SPM, Deurne (Belgium)

Locations

AZ Monica, Orthopedisch centrum SPM

Deurne, , Belgium

Countries

Belgium

Other Identifiers

VSK-BE-2011-11

Identifier Type: -

Identifier Source: org_study_id