Big toe osteoarthritis surgery reduces pain significantly better than “watchful waiting”, indicates the first ever randomized study on the subject

Hallux rigidus, osteoarthritis in the base joint of the big toe, is one of the most common types of osteoarthritis in the foot. Up to eight percent of over fifty-year-olds suffer from it. The established standard treatment for progressed osteoarthritis has been fusion surgery, arthrodesis, but its effectiveness has not been previously evaluated against the natural course of the disease in a randomized trial.

“This comparative study provides reliable information for the first time on the true effect of surgery on symptoms,” says the study's principal investigator, Lic Med, Mikko Miettinen from HUS.

The study carried out at HUS involved ninety patients over the age of 40 who suffered from symptoms caused by osteoarthritis in the base joint of the big toe (first metatarsophalangeal joint). The participants were randomly assigned to either the surgery group or the watchful waiting group, in which the natural progression of the disease was monitored and supported.

After one year, walking-related pain had gone down from a score of 6 to 1.3 in the surgery group (on a scale of 0 to 10) while in the watchful waiting group it remained almost unchanged at 5.7. The standardized difference between the groups was nearly triple compared to the prescribed minimal clinical important difference (1.7 points). Nearly all secondary outcomes supported surgery as the better option as well and neither group experienced severe adverse events.

More than sixty percent of the watchful waiting group ended up getting surgery

By the end of the year, 64 percent of the patients randomized to the watchful waiting group had requested and received surgery.

“Fusion surgery has long been considered the standard treatment for osteoarthritis in the first metatarsophalangeal joint, but only now has it’s superiority over watchful waiting been demonstrated in a study from which reliable conclusions can be drawn,” says Miettinen.

Results of the study mean faster pain relief for patients through surgery

The results of the study provide strong evidence that fusion surgery is likely to significantly reduce pain and improve quality of life with a low risk of complications in middle-aged and older patients who suffer from persistent pain caused by osteoarthritis in the base joint of the big toe.

However, the results cannot be generalized to all causes of pain in the base joint of the big toe. The study excluded, among others, patients with rheumatoid osteoarthritis as well as those with uncontrolled diabetes, and patients with increased hallux valgus angle. 

Part of the broader research by the FICEBO research group

The director of the study, Lasse Rämö, M.D., Ph.D. and senior researcher, Tuomas Lähdeoja, M.D., Ph.D. are both members of the FICEBO research group. FICEBO is known for studies in which common surgeries, such as partial knee meniscectomy or subacromial decompression surgery of the shoulder, have been compared with placebo surgery, often with results that have called the benefits of these surgeries into question. The results of the HARD study were the opposite: the surgery proved clearly useful.

“Several of our previous studies involving the surgical treatment of degenerative illnesses have indicated that surgery does not provide additional benefits. The results of HARD remind us that we conduct these studies to provide reliable information about treatment options, not to demonstrate that surgery is unnecessary. This time, however, surgery proved clearly more effective, which is a relief from a surgeon's perspective as well,” says Rämö.

Research article: Surgery Versus Watchful Waiting for First Metatarsophalangeal Joint Osteoarthritis: A Randomized Controlled Trial

Inquiries

Mikko Miettinen
Lic. Med., principal investigator, HUS
tel. 050 428 4630, mikko.miettinen@hus.fi

Lasse Rämö
M.D., Ph.D., study director, FICEBO research group
tel. 050 427 2479, lasse.ramo@hus.fi

FICEBO research group (Finnish Centre for Evidence-Based Orthopaedics) operates in the University of Helsinki and at HUS The group is internationally recognized as a pioneer of surgical research and evidence-based medicine in Finland.