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Early Viscosupplementation After ACL Reconstruction: a Randomized Controlled Trial

NCT02630407 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-09-13

No results posted yet for this study

Summary

The possibility of using an intra-articular agent such as hyaluronic acid (HA) to reduce the post-operative inflammatory stress on the knee joint, limiting the use of other pain-killers and promoting a faster recovery after ACL reconstruction, seems attractive.

The aim of the present double blind, placebo controlled study is to evaluate the effects, both in terms of pain control and functional recovery, provided by a single HA injection performed in the early postoperative phase after ACL reconstruction.

The day after the ACL reconstruction (which is performed with the same technique for all the patients enrolled), the patients were randomized to receive a single injection of HA or 3 ml of saline solution. The randomization list was kept in a dedicated office and the injecting physician contacted it to know the treatment allocation just before the injection, that was performed by a lateral parapatellar approach, after removing the drainages and after attempting aspiration to evacuate any eventual residual blood from the joint. In order to maintain the patient blind to the treatment, a surgical drape was placed to prevent him to see the injective procedure.

All patients will be evaluated at 15, 30, 60, 180 and 360 days after surgery by using the following tools: SF-36, IKDC subjective, VAS for pain, EQ-VAS for general Health Status and Tegner score. Also the trans-patellar circumference and active and passive ROM of both knees were registered at each follow-up evaluation.

Conditions

  • Complete Tear, Knee, Anterior Cruciate Ligament

Interventions

BIOLOGICAL

viscosupplementation

A single 3 ml hyaluronic acid (HA) injection (viscosupplementation) performed the day after ACL reconstruction, after drainage removal

OTHER

Placebo group

A single 3 ml saline injection performed the day after ACL reconstruction, after drainage removal

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Elizaveta Kon, MD · II Clinic & Nano-biotechnology Lab, Rizzoli Orthopaedic Institute, Bologna, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02630407 on ClinicalTrials.gov