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Hyaluronic Acid Injection Post Arthroscopy - Does it Improve Immediate Function? Double Blind Controlled Prospective Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01442571
First received: September 4, 2011
Last updated: September 27, 2011
Last verified: August 2011
  Purpose
The proposed research is to examine the effect of injecting a large volume of HA (10cc) at the time of post arthroscopy suture removal (9-11 day post surgery), in patients with cartilage damage of ICRS grade 2 and above in one of the knee compartments.

Condition Intervention Phase
Cartilage Injury
Device: Hyaluronic Acid Injection
Drug: Saline Injection
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • IKDC (the International Knee Documentation Committee) [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Arms Assigned Interventions
Experimental: Hyaluronic Acid Injection, pain, function Device: Hyaluronic Acid Injection
Placebo Comparator: Saline Injection Drug: Saline Injection

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult Men and Women, who underwent arthroscopy of the knee with cartilage injury of ICRS grade 2 or higher in one of the compartments (in addition to other injuries such as meniscal tear and cruciate ligament).

Exclusion Criteria:

  • Patients with known rheumatic disorders.
  • Known hypersensitivity to HA.
  • Synovial diseases like PVNS, under 18y old.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442571

Locations
Israel
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01442571     History of Changes
Other Study ID Numbers: sports01-CTIL-HMO 
Study First Received: September 4, 2011
Last Updated: September 27, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Adult Men and Women, who underwent arthroscopy of the knee with cartilage injury of ICRS grade 2 or higher

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on December 09, 2016