Finnish Shoulder Impingement Arthroscopy Controlled Trial
The FIMPACT Trial is an ongoing multi-centre randomized controlled trial (RCT) carried out in the Helsinki University Hospital (Töölö and Jorvi hospitals, Helsinki and Espoo) and Hatanpää City Hospital (Tampere).
What is the primary objective of the FIMPACT trial?
We aim to determine whether arthroscopic subacromial decompression (ASD), the most commonly performed shoulder surgery, is an effective treatment for patients with subacromial shoulder pain (a.k.a., shoulder impingement).
Why is this trial needed?
Shoulder pain poses a significant socioeconomic burden with subacromial shoulder syndrome being the most typical cause of shoulder problems in the general population. The pathognomonic clinical sign of SIS, subacromial pain while lifting the arm, is commonly attributed to ’impingement’ of the rotator cuff tendons between the humeral head and the overlying acromion. ASD procedure is premised on this rationale: the undersurface of the acromion is smoothened to decompress the RC tendon passage through the subacromial space. ASD has become one of the most frequently performed orthopaedic procedures in the world. With the advent of arthroscopy, the number of subacromial decompression procedures has increased many times between the 1980s and the 2010s.
Given its’ popularity, absence of any compelling or concrete evidence in support of ASD may come as a surprise. To date, the evidence in support of ASD consists of some before-after studies on patients undergoing ASD and RCTs comparing ASD to conservative treatment. However, no evidence exists that ASAD is more effective than simply inserting the arthroscope or doing nothing at all. FIMPACT trial aims to fill this evidence void.
What is the study design?
FIMPACT is the first-ever randomized, placebo-surgery controlled trial comparing subacromial decompression surgery (ASD) against diagnostic arthroscopy (DA, a placebo surgical comparator). In addition, ASD will be separately compared to exercise therapy (ET).
We will use two primary outcome measures, pain at rest and pain at activity (using a VAS scale), both at 24 months.