FINTASY

The FINTASY trial is an ongoing multi-centre randomized controlled trial conducted in four hand surgery departments in Finland: Tampere University Hospital (coordinating centre), Helsinki University Hospital, Hospital Nova of Central Finland (Jyväskylä), and Kuopio University Hospital.

What is the primary objective of the FINTASY trial?

We aim to determine the efficacy of trapeziectomy, the gold standard surgery for patients with painful thumb basal joint (CMC1 joint) osteoarthritis.

Why is this trial needed?

Thumb basal joint osteoarthritis is a common, painful condition of the hand, affecting the quality of life of up to 10% of women and 5% of men in their sixties. Typically, patients experience pain during daily activities that require pinching or grasping objects with the thumb.

Trapeziectomy (surgical removal of the trapezium bone) is based on the rationale that pain subsides when the affected joint surface is removed. Although several modifications of the procedure exist, none have proven superior to simple trapeziectomy. Therefore, trapeziectomy has become the established, gold standard surgery for this condition.

The absence of robust evidence on the efficacy of such a widely performed procedure is startling. The evidence supporting trapeziectomy consists mainly of small before–after studies and RCTs comparing different surgical techniques, but no credible evidence exists on whether trapeziectomy itself is effective.

The FINTASY trial aims to fill this evidence gap by studying the efficacy of trapeziectomy in the treatment of thumb basal joint osteoarthritis using placebo surgery as the comparator.

What is the study design?

FINTASY is the first-ever randomized, placebo surgery–controlled trial assessing the efficacy of trapeziectomy for painful thumb osteoarthritis. We will use the Patient-Rated Wrist and Hand Evaluation (PRWHE), a validated outcome instrument for assessing wrist and hand pain and function in daily activities, as the primary outcome measure.

Where are we now?

The start of recruitment was delayed—like so many other studies—due to the COVID-19 pandemic, and we were only able to begin enrolling participants in February 2022. Recruitment has progressed slowly but steadily since then.

We did not remain idle during the COVID pause. Even before the trial began, we had collected a prospective pilot dataset following patients undergoing trapeziectomy. This work produced several important methodological and clinical publications:

• Responsiveness of different pain measures and recall periods in people undergoing surgery after a period of splinting for basal thumb joint osteoarthritis demonstrated that all studied pain measures captured change over time, recommending the PRWHE pain subscale or NRS past week for their superior signal-to-noise ratio. Read more
• A study on MID and PASS thresholds (Minimal important difference and patient acceptable symptom state for the Patient-Rated Wrist/Hand Evaluation and pain scales in patients with basal thumb osteoarthritis) found credible MID estimates for NRS and PRWHE, showing that cut-offs for MID and PASS had good to excellent discrimination, supporting their use in future studies. Read more
• Most recently, we received acceptance for a feasibility pilot study (Orthosis Followed by Trapeziectomy for Thumb Base Osteoarthritis), which showed that six weeks of continued nonsurgical treatment with an orthosis resulted in negligible symptom relief, while trapeziectomy led to large and clinically important improvements within three months. However, it remains unclear how much of this improvement is attributable to surgery itself.

The protocol manuscript is in its final stages of preparation and will be submitted for publication soon.

Project team

Susanna Stjernberg-Salmela – Kati Jaatinen – Eero Waris – Simo Mattila – Simo Taimela – Tomasz Czuba - Leena Caravitis – Pirjo Toivonen – Teppo Järvinen

Contributors

Matti Juntunen – Elina Jalava – Margit Karelson – Henrikki Rönkkö – Marketta Rautanen – Maija Lehtoranta – Toni Luokkala – Olli-Pekka Kangasniemi