Early Viscosupplementation After ACL Reconstruction: a Randomized Controlled Trial
Condition: Complete Tear, Knee, Anterior Cruciate Ligament
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Viscosupplementation is an injective approach used in the orthopaedic practice to manage
      chondropathy and osteoarthritis (OA) in different joints. In the last decades, several
      products have been developed by biomedical industries, with different biochemical and
      physical properties, with the aim of providing the best and long-lasting beneficial effects
      in OA patients. The rational supporting the use of viscosupplementation is due both to its
      biomechanical and biological actions. First of all, hyaluronic acid (HA) exerts a lubricant
      effect improving the rheological properties of synovial fluid thus reducing the mechanical
      stresses within the joint that are responsible for the activation of nociceptors and further
      cartilage surface wear. Furthermore, HA binds to cellular receptors and further stimulates
      endogenous production of hyaluronan, other extracellular matrix components, and it also
      counteracts inflammatory molecules and proteases that are overexpressed in a diseased joint .
      In light of these features, HA could be considered an "intra-articular drug" which can act
      both as a pain killer and joint regulator agent. These properties could be theoretically
      exploited also for different clinical applications than a chronic disease like OA. In
      particular, viscosupplementation might play a beneficial role in restoring the overall joint
      homeostasis and might contribute to reduce pro-inflammatory stimuli after knee surgical
      procedures, thus reducing pain and accelerating functional recovery. Anterior cruciate
      ligament (ACL) reconstruction is one of the most common procedures in the field of sports
      medicine . It is common for patients to experience persistent knee swelling after the
      surgical procedure, and this increases pain and delays the start of the rehabilitation
      program, thus prolonging the times of full functional recovery. The possibility of using an
      intra-articular agent such as HA to reduce the post-operative inflammatory stress on the
      knee, limiting the use of other pain-killers and promoting a faster recovery after ACL
      reconstruction, seems therefore attractive.

      The aim of the present double blind, placebo controlled randomized 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
      subjects 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 this office 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.
    

Intervention name(s): viscosupplementation; Placebo group
Intervention type(s): Biological; Other
Intervention description(s): A single 3 ml hyaluronic acid (HA) injection (viscosupplementation) performed the day after ACL reconstruction, after drainage removal; A single 3 ml saline injection performed the day after ACL reconstruction, after drainage removal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: injection of saline VS injection of Hyaluronic acid
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment