Evaluating the Efficacy of Intra-articular Injection of High molecular weight Hyaluronic Acid on the Knee Performance of Patient with Tibial Plateau Fracture after Surgical Intervention

Evaluating the Efficacy of Intra-articular High Molecular Weight Hyaluronic Acid Injection on the Knee Performance of Patient with Tibial Plateau Fracture after Surgical fixation

This is a randomized, triple blinded, placebo control, clinical trial with two parallel groups.

Participants received intra-Articular injection by an orthopedic surgeons who were not involved in other aspects of this investigation. Participants, investigators, outcome assessors, data analyst and patients were blinded.

Included participants were adults (18-65 years old), who had tibial plateau fracture and were candidates for fixation operation and signed the informed consent Excluded patients were pregnant and nursing mothers, past medical history of diabetes mellitus, severe osteoarthritis, sever osteoporesis, those who were not candidates for surgical fixation (Active septic disorders of knee joint and tissues around the knee, coagulopathies, active rheumatologic disorders, Heart Failure, Chronic obstructive pulmonary disease, ....), those with open fractures and those with failure to perform internal fixation due to extensive tissue damage

All participants received 2 injections with 2 weeks interval, the first injection was done 2 weeks after fixation operation have done. Intervention group received 2 ml high molecular hyaluronic acid (Synogel) contained 32 mg in 2 ml and placebo group received 2 ml normal saline in each injection.

Pain and knee function were assessed by Visual Analogue Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score) in zero point (2 weeks after fixation operation), 2 weeks and 22 weeks after, and also the range of motion was assessed by goniometre.

With block randomization and allocation the patients into eight blocks with four patients in each group.

All Participants, Investigators, Outcome assessors, Data analyst and quality controller are blinded, however as the viscosity of the Hyaluronic Acid are dramatically higher than normal saline solution used as placebo, it was impossible to blind the practitioner who will do the injections, so an independent physician handled the injections.

The whole potential data is unpublished after being unidentifiable.

Start the access period 6 months after printing the results.

Researchers working in academic and industrial institutions.

Researchers working in academic and industrial institutions.

Dr. Hadi Esmaily, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences.

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