SLR - August 2009 - Samuel A. Feinberg
Reference:
Pons, M., Fernando, A., Solana, J., Viladot, R., Varela, L. (2007). Sodium hyaluronate in the treatment ofHallux Rigidus: A single-blind, randomized study. Foot and Ankle International (Spain), 28, 38-42
Scientific Literature Review
Reviewed by: Samuel A. Feinberg DPM
Residency Program: OCPM-UHHS Richmond Medical Center
Podiatric Relevance:
This study demonstrates the effectiveness and safety of sodium hyaluronate (Ostenil mini) as an intra-articular injection for the treatment of hallux rigidus.
Methods:
Thirty-seven patients aged 40-80 years old were enrolled in this single-blind randomized study. All patients enrolled in the study had painful early stage hallux rigidus with or without hallux valgus deformity. Patients with grade II or III osteoarthritis of the 1st MPJ, foot deformities, or pain that might alter with the clinical assessment of the 1st MPJ were excluded. Patients who had previous surgery, infections, previous treatment of intra-articular injections, or who had sensitivity to sodium hyaluronate or corticoids were excluded from the study. Patients were randomly chosen into one of two groups for either a sodium hyaluronate (Ostenil mini) injection or a triamcinolone acetonide (Trigon depot) injection. The study was conducted over a 3-month period with evaluations on day 0, 14,28,56,84. Outcome was assessed using the following
parameters; VAS-target joint pain at rest or on palpation, target joint pain during dorsiflexion and plantarflexion, pain on walking 20 meters wearing ordinary shoes, American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux evaluation, use of rescue pain medication, and global assessment of the treatment by the patient and the investigator using a 5-point scale (0-5).
Results:
Forty first metatarsophalangeal joints were injected of 37 patients. Twenty of the joints were injected with sodium hyaluronate and the other twenty were injected with triamcinolone acetonide. There was a decrease in joint pain compared to baseline at rest, dorsiflexion, and plantarflexion in both treatment groups with no statistical significance between the type of injection. There was a decrease in joint pain score when walking 20 meters compared to baseline with a statistical difference between sodium hyaluronate and triamcinolone acetonide in favor of sodium hyaluronate at days 28 and 56. The AOFAS hallux metatarsophalangeal score showed an
improvement in the mean total score in both treatment groups compared to the baseline with a significant advantage with the sodium hyaluronate group at all follow up visits.
Conclusions:
In review of these findings, an intra-articular injection for early onset hallux rigidus can be beneficial for the patient in the short term with either sodium hyaluronate or triamcinolone acetonide. This study showed that the sodium hyaluronate injection was significantly better than the triamcinolone acetonide in some of the categories. There was a one year follow up and seven of the 15 sodium hyaluronate patients had required surgery (46.6%), and nine of the 17 triamcinolone acetonide patients had required surgery (52.9%). Four patients were lost, two from each group.