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NCT01442571 Clinical Trial

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

Cartilage Injury Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01442571
Other study ID # sports01-CTIL-HMO
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received September 4, 2011
Last updated September 27, 2011

Study information
Verified date August 2011
Source Hadassah Medical Organization
Contact Hadas Lemberg, PhD
Phone 00 972 2 6777572
Email lhadas@hadassah.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Device:
• Hyaluronic Acid Injection

Drug:
• Saline Injection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary IKDC (the International Knee Documentation Committee) Yes
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