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

Hadassah Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Cartilage Injury

Treatments: Device: Hyaluronic Acid Injection; Drug: Saline Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01442571

sports01-CTIL-HMO

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Hyaluronic Acid Injection, pain, function

Experimental group

Treatment:

Device: Hyaluronic Acid Injection

Saline Injection

Placebo Comparator group

Treatment:

Drug: Saline Injection