Early Viscosupplementation After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial.

Abstract

BACKGROUND:

Hyaluronic acid (HA) has been widely used to treat osteoarthritis given its biological and mechanical properties. Because HA is an "intra-articular" treatment approach that affects the joints, it could be used in the management of acute conditions, such as during the early postsurgical phase, to reduce inflammatory stress and improve articular function.

PURPOSE:

The aim of the present double-blind, randomized controlled trial was to evaluate pain control and functional recovery provided by a single injection of HA performed the day after anterior cruciate ligament (ACL) reconstruction.

STUDY DESIGN:

Randomized controlled trial; Level of evidence, 1.

METHODS:

The study enrolled 60 patients affected by primary, chronic, and symptomatic ACL tear requiring surgical reconstruction. All patients were treated with the same reconstructive technique and rehabilitation protocol. Exclusion criteria were (1) concurrent articular lesion requiring surgical treatment, (2) axial malalignment in the index limb, and (3) functional limitation or pain in the contralateral knee. The day after the procedure, the patients were randomized to receive a single injection of 3 mL HA or 3 mL saline solution after surgical drains were removed. All patients were evaluated at baseline and at 15, 30, 60, and 180 days and 12 months after surgery by use of the following tools: Short Form-36 Health Survey (SF-36), International Knee Documentation Committee (IKDC) subjective score, visual analog scale (VAS) for pain, VAS for general health status, and Tegner score. At each follow-up evaluation, the transpatellar circumference and active and passive range of motion (ROM) of both knees were recorded.

RESULTS:

No severe adverse events were documented after early viscosupplementation. A significant improvement was documented in both treatment groups. Significant differences were documented in the transpatellar circumference at 60 days and in active ROM at 30 days postoperatively; patients who received HA had better values compared with the placebo group (P = .022 and .027, respectively). No statistically relevant intergroup differences were found in the clinical scores.

CONCLUSION:

The study documented no adverse events and had some positive findings in terms of active ROM recovery and transpatellar circumference reduction. However, the early postoperative application of viscosupplementation did not lead to significant improvement in clinical scores after ACL reconstruction.

REGISTRATION:

NCT02630407 (ClinicalTrials.gov identifier).

• Authors: Alessandro Di Martino, Francesco Tentoni, Berardo Di Matteo, Alessia Cavicchioli, Mirco Lo Presti, Giuseppe Filardo, Stefano Zaffagnini, Maurilio Marcacci, Elizaveta Kon
• Journal: The American journal of sports medicine (Am J Sports Med) Vol. 44 Issue 10 Pg. 2572-2578 (Oct 2016) ISSN: 1552-3365 [Electronic] United States
• PMID: 27466224 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: © 2016 The Author(s).

Chemical References

• Hyaluronic Acid

Topics

• Adult
• Anterior Cruciate Ligament (surgery)
• Anterior Cruciate Ligament Injuries (surgery)
• Anterior Cruciate Ligament Reconstruction (methods)
• Double-Blind Method
• Female
• Humans
• Hyaluronic Acid (administration & dosage)
• Knee Joint (surgery)
• Male
• Pain (surgery)
• Pain Measurement
• Postoperative Period
• Range of Motion, Articular
• Recovery of Function
• Treatment Outcome
• Viscosupplementation
• Young Adult