Efficiency of Hyaloglide® in the Prevention of the Recurrence of Adhesions after Tenolysis of Flexor Tendons in Zone II: a Randomized, Controlled, Multicentre Clinical Trial.

Author(s): Riccio M, Battiston B, Pajardi G, Corradi M, Passaretti U, Atzei A, et al.

Source: J Hand Surg 35E:130-138, 2010.

Summary:

Selected members of the Italian Society for Surgery of the Hand completed a randomized, controlled, multicenter clinical trial to assess the efficacy of Hyaloglide® in preventing adhesion formation after tenolysis of adherent repaired flexor tendons in zone II of the hand.  In the control group of 19 patients, a standard release was performed.  In the treated group of 26 patients, Hyaloglide® was applied into the flexor sheath and around the site of tenolysis.   All patients were evaluated at specified time points for duration of 6 months following surgery.  Patients in the Hyaloglide® group had a statistically better recovery of finger motion at all time intervals and returned earlier to work and daily activities.  There was one complication in the treatment group: a tendon rupture that was considered as a consequence of the tenolysis.

Healing tendons become surrounded by a fibrin rich inflammatory exudate which later may convert to scar tissue producing adhesions between the injured/repaired tendon and tendon sheath.  Hyaluronic acid is present in high concentrations in tendon sheaths, but the concentration decreases during the initial phases of tendon healing.  Hyaloglide® is a thick and sticky hyaluronan-based gel which adheres to the surface of the repaired tendon to prevent contact between the repair site and surrounding tissues.  The product is resorbed in approximately 10 days and has shown promise as an anti-adhesion device in preclinical and clinical studies of tendon and peripheral nerve surgery (Atzei et al, Microsurgery 2007; Brunelli et al, J Orthop Res 2005; Dam-Hieu et al, Neurosurgery 2005; Smit et al, J Neurosurg 2004).