The feasibility of performing a randomised controlled trial for femoroacetabular impingement surgery

Abstract

ObjectivesThe number of surgical procedures performed each year to treat femoroacetabular impingement (FAI) continues to rise. Although there is evidence that surgery can improve symptoms in the short-term, there is no evidence that it slows the development of osteoarthritis (OA). We performed a feasibility study to determine whether patient and surgeon opinion was permissive for a Randomised Controlled Trial (RCT) comparing operative with non-operative treatment for FAI.MethodsSurgeon opinion was obtained using validated questionnaires at a Specialist Hip Meeting (n = 61, 30 of whom stated that they routinely performed FAI surgery) and patient opinion was obtained from clinical patients with a new diagnosis of FAI (n = 31).ResultsClinical equipoise was demonstrated when surgeons were given clinical scenarios and asked whether they would manage a patient operatively or non-operatively. A total of 23 surgeons (77%) who routinely perform FAI surgery were willing to recruit patients into a RCT, and 28 patients (90%) were willing to participate. 75% of responding surgeons believed it was appropriate to randomise patients to non-operative treatment for ≥ 12 months. Conversely, only eight patients (26%) felt this was acceptable, although 29 (94%) were willing to continue non-operative treatment for six months. More patients were concerned about their risk of developing OA than their current symptoms, although most patients felt that the two were of equal importance.ConclusionsWe conclude that a RCT comparing operative and non-operative management of FAI is feasible and should be considered a research priority. An important finding for orthopaedic surgical trials is that patients without life-threatening pathology appear willing to trial a treatment for six months without improvement in their symptoms.

Past and projected temporal trends in arthroscopic hip surgery in England between 2002 and 2013

“…Indeed, equipoise is present within surgeon and patient communities for the arthroscopic treatment of FAI. 19 Results from robust clinical trials will inform decision makers and may give rise to more standardised care. Our forecast rise in the number of arthroscopic hip procedures of 1388% between 2002 and 2023 will accentuate challenging funding decisions within the NHS.…”

“…This is particularly salient given the increasing questions raised over the efficacy of arthroscopic knee surgery. 18 Randomised controlled trials are required to compare the efficacy of arthroscopic hip surgery with non-operative interventions, 19 and such studies are currently recruiting patients. 20 The adoption of hip arthroscopy in the UK has not been described.…”

Femoroacetabular impingement surgery: are we moving too fast and too far beyond the evidence?

“…It is also, therefore, too soon to conclude whether progression of OA is delayed with surgical correction 16 54 84 123. Experienced hip surgeons asserting that the link between morphology and OA of the hip has been established suggest that “not infrequently, we have come across patients with cam morphology who stand the test of time with minimal or no symptoms”109 and that “a large number of cam lesions are being excised unnecessarily.”124 RCTs comparing surgical and non-surgical management of FAI (and potential future OA development) are suggested as a future research priority 125…”

Protocol for the Femoroacetabular Impingement Trial (FAIT)

“…There is uncertainty as to how symptomatic FAI is best treated 8 and the principal two management options are physiotherapy with activity modification or surgery. Both modalities have been shown to improve symptoms in the short term, 9 - 14 however, no published studies compare efficacy with each other or with sham procedures.…”

“…These two treatment modalities were chosen as comparators in a randomised controlled trial (RCT) after our feasibility study demonstrated equipoise amongst clinicians specialising in the field. 8 The feasibility study results have guided study design and the protocol was drafted in accordance with the SPIRIT 2013 Statement. 15 …”