Hip Viscosupplementation: What is the Best Dosage? (Hip VS)

• ClinicalTrials.gov Identifier: NCT01810809
• Recruitment Status: Unknown
• First Posted: March 14, 2013
• Last Update Posted: September 11, 2013
• Sponsor: University of Sao Paulo General Hospital
• Information provided by (Responsible Party): University of Sao Paulo General Hospital

Study Description

Brief Summary:

Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. Our objective is to determine the optimal dosis for hip viscosupplementation

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Procedure: articular lavage with saline injection; Drug: 1 ampoule of Hylan GF-20; Drug: 2 ampoules of Hylan GF-20; Drug: 3 ampoules of Hylan GF-20	Phase 4

Detailed Description:

Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. Any osteoarthritic joint is eligible to this treatment modality, but the great majority of studies are for knee viscosupplementation. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. We will prospectively enroll 80 patients with hip osteoarthritis and will randomize them into four groups: Group zero will receive joint lavage with saline injection. Group 1 will receive joint lavage with saline injection and 2 ml of Hylan GF-20 (1 ampoule of Synvisc Classic®). Group 2 will receive joint lavage with saline injection and 4 ml of Hylan GF-20 (2 ampoules of Synvisc Classic®). Group 3 will receive joint lavage with saline injection and 6 ml of Hylan GF-20 (3 ampoules of Synvisc Classic®). The Visual Analogic Scale of Pain (VAS), the Western Ontario and McMaster Universities Index (WOMAC®), and Lequesne questionnaires were completed at baseline and at Weeks 1, 4, 12, and 24. Our objective is to determine the optimal dosis for hip viscosupplementation

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Hip Viscosupplementation: What is the Best Dosage?
• Study Start Date: April 2013
• Estimated Primary Completion Date: June 2014
• Estimated Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Articular Lavage; Patients from Group Zero will receive articular lavage with saline injection	Procedure: articular lavage with saline injection; Patients will receive articular lavage with saline injection
Experimental: Group 1; Patients from Group 1 will receive articular lavage with saline injection and viscosupplementation with 2ml (1 ampoule) of Hylan GF-20	Procedure: articular lavage with saline injection; Patients will receive articular lavage with saline injection; Drug: 1 ampoule of Hylan GF-20; Patients will receive viscosupplementation with 2ml (1 ampoule) of Hylan GF-20; Other Name: 1 ampole of Synvisc Classic
Experimental: Group 2; Patients from Group 2 will receive articular lavage with saline injection and viscosupplementation with 4ml (2 ampoules) of Hylan GF-20	Procedure: articular lavage with saline injection; Patients will receive articular lavage with saline injection; Drug: 2 ampoules of Hylan GF-20; Patients will receive viscosupplementation with 4ml (2 ampoules) of Hylan GF-20; Other Name: 2 ampoles of Synvisc Classic
Experimental: Group 3; Patients from Group 3 will receive articular lavage with saline injection and viscosupplementation with 6ml (3 ampoules) of Hylan GF-20	Procedure: articular lavage with saline injection; Patients will receive articular lavage with saline injection; Drug: 3 ampoules of Hylan GF-20; Patients will receive viscosupplementation with 6ml (3 ampoules) of Hylan GF-20; Other Name: 3 ampoules of Synvisc Classic

Outcome Measures

Primary Outcome Measures :

1. WOMAC [ Time Frame: 6 months ]
   Pain and function assessment with WOMAC questionaire
2. VAS [ Time Frame: 6 months ]
   Pain assessment with Visual Analogic Scale (VAS)
3. Lequesne [ Time Frame: 6 months ]
   Pain and function assessment with Lequesne questionaire

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Met the American College of Rheumatology criteria for hip osteoarthritis
• No hip intraarticular injections in the last 6 months

Exclusion Criteria:

- Severe reaction to the procedure

Contacts and Locations

Contacts

Contact: Gustavo C de Campos, MD; +551983318000; gustavoccampos@terra.com.br

Contact: Marcia U Rezende, PhD; +5511981226282; murezende@uol.com.br

Locations

Brazil

Instituto de Ortopedia e Traumatologia HC-FMUSP; Recruiting

São Paulo, SP, Brazil, 05410-000

Contact: Valquiria +551126616888

Principal Investigator: Marcia U Rezende, Phd

Sponsors and Collaborators

University of Sao Paulo General Hospital

Investigators

• Principal Investigator: Gustavo C de Campos, MD; FMUSP

More Information

• Responsible Party: University of Sao Paulo General Hospital
• ClinicalTrials.gov Identifier: NCT01810809 History of Changes
• Other Study ID Numbers: 0255/10
• First Posted: March 14, 2013
• Last Update Posted: September 11, 2013
• Last Verified: September 2013

Keywords provided by University of Sao Paulo General Hospital:

Osteoarthritis; Hip; Viscosupplementation; Clinical Trial

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Hylan; Viscosupplements; Protective Agents; Physiological Effects of Drugs