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Griffin D1,2, Dickenson E1,2, Wall P1,2, Achana F3, Donovan J4, Griffin J5, Hobson R6, Hutchinson C7, Jepson M4, Parsons N5, Petrou S7, Realpe A4, Smith J8, Foster N9
1University Hospitals of Coventry and Warwickshire NHS Trust, Orthopaedics, Coventry, United Kingdom, 2University of Warwick, Orthopaedics, Coventry, United Kingdom, 3University of Warwick, Health Economics, Coventry, United Kingdom, 4University of Bristol, Bristol, United Kingdom, 5University of Warwick, Statistics, Coventry, United Kingdom, 6University of Warwick, Warwick Clinical Trials Unit, Coventry, United Kingdom, 7University of Warwick, Coventry, United Kingdom, 8University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, United Kingdom, 9Keele University, Arthritis Research UK Primary Care Centre, Keele, United Kingdom
Background: Femoroacetabular impingement syndrome (FAI) is a common cause of hip and groin pain in young adults. It is thought to arise from a bony prominence of the femoral head-neck junction (cam type) or prominence of the rim of the acetabulum (pincer type), or both. Premature contact between the femur and acetabulum during activity is thought to lead to damage to the labrum and articular cartilage, causing pain. Physiotherapy and surgery are both used to treat FAI syndrome but there is little robust evidence of effectiveness.
Purpose: UK FASHIoN compared the clinical and cost-effectiveness of arthroscopic hip surgery (HA) versus best conservative care in patients with FAI syndrome.
Methods: UK FASHIoN was a pragmatic, multicentre, 2 parallel arm, superiority, RCT in patients with FAI presenting to 23 hospitals in the UK. Eligible patients were over 16 without radiographic signs of osteoarthritis, deemed suitable for arthroscopic FAI surgery. Participants were randomly allocated (1:1 ratio with minimisation by study site and impingement type) to HA or Personalised Hip Therapy (PHT - a physiotherapist-led, individual, supervised and progressed programme comprising 6 to 10 sessions that included patient assessment, education, help with pain relief and exercise). The primary outcome measure was hip-related quality of life using the patient-reported International Hip Outcome Tool (iHOT-33) at 12 months (score 0-100, higher scores indicate better quality of life, and the minimal clinical important difference is 6.1). Secondary outcomes included generic health-related quality of life (EQ-5D-5L, SF-12), adverse events, and cost-effectiveness. Primary analysis compared the differences in iHOT-33 scores at 12 months between groups, by intention to treat. Cost-effectiveness analysis took an NHS and personal social services perspective.
Results: Of 648 patients who were eligible to take part, 348 were randomised (171 to HA; 177 to PHT). There were no important differences between the groups at baseline. The average time to surgery was 132 days (SD 71) versus 47 days (SD 52) to PHT. 92.5% were followed-up for the primary outcome at 12 months. Baseline mean and standard deviation in iHOT-33 scores were 39.2 (SD 21) and 35.6 (SD 18) in the surgery and PHT groups, and 58.8 (SD 27) and 49.7 (SD 25) at 12 months, respectively. On average, patients in both groups improved over 12 months, and the mean iHOT-33 score increased more in those allocated to HA than to PHT; mean difference of 6.8 points (95% CI 1.7,12.0 p=0.009) in favour of surgery. The adjusted incremental cost of HA compared with PHT over 12 months was £2372, with incremental QALYs of -0.015 (a net QALY loss). PHT was more cost-effective than HA at 12 months.
Conclusion(s): Treatment of patients with FAI syndrome with a strategy of either physiotherapy-led best conservative care or arthroscopic hip surgery led to improved hip-related quality of life. At 12-month follow-up that improvement was significantly greater in those allocated to surgery than in those allocated to conservative care. Hip arthroscopy was associated with higher overall costs than conservative care over 12 months.
Implications: Further follow-up will determine longer-term clinical and cost-effectiveness.
Keywords: hip impingement syndrome, surgery, physiotherapist-led exercise
Funding acknowledgements: National Institute for Health Research (NIHR) Health Technology Assessment programme (grant numbers 10/41/02 and 13/103/02).
Purpose: UK FASHIoN compared the clinical and cost-effectiveness of arthroscopic hip surgery (HA) versus best conservative care in patients with FAI syndrome.
Methods: UK FASHIoN was a pragmatic, multicentre, 2 parallel arm, superiority, RCT in patients with FAI presenting to 23 hospitals in the UK. Eligible patients were over 16 without radiographic signs of osteoarthritis, deemed suitable for arthroscopic FAI surgery. Participants were randomly allocated (1:1 ratio with minimisation by study site and impingement type) to HA or Personalised Hip Therapy (PHT - a physiotherapist-led, individual, supervised and progressed programme comprising 6 to 10 sessions that included patient assessment, education, help with pain relief and exercise). The primary outcome measure was hip-related quality of life using the patient-reported International Hip Outcome Tool (iHOT-33) at 12 months (score 0-100, higher scores indicate better quality of life, and the minimal clinical important difference is 6.1). Secondary outcomes included generic health-related quality of life (EQ-5D-5L, SF-12), adverse events, and cost-effectiveness. Primary analysis compared the differences in iHOT-33 scores at 12 months between groups, by intention to treat. Cost-effectiveness analysis took an NHS and personal social services perspective.
Results: Of 648 patients who were eligible to take part, 348 were randomised (171 to HA; 177 to PHT). There were no important differences between the groups at baseline. The average time to surgery was 132 days (SD 71) versus 47 days (SD 52) to PHT. 92.5% were followed-up for the primary outcome at 12 months. Baseline mean and standard deviation in iHOT-33 scores were 39.2 (SD 21) and 35.6 (SD 18) in the surgery and PHT groups, and 58.8 (SD 27) and 49.7 (SD 25) at 12 months, respectively. On average, patients in both groups improved over 12 months, and the mean iHOT-33 score increased more in those allocated to HA than to PHT; mean difference of 6.8 points (95% CI 1.7,12.0 p=0.009) in favour of surgery. The adjusted incremental cost of HA compared with PHT over 12 months was £2372, with incremental QALYs of -0.015 (a net QALY loss). PHT was more cost-effective than HA at 12 months.
Conclusion(s): Treatment of patients with FAI syndrome with a strategy of either physiotherapy-led best conservative care or arthroscopic hip surgery led to improved hip-related quality of life. At 12-month follow-up that improvement was significantly greater in those allocated to surgery than in those allocated to conservative care. Hip arthroscopy was associated with higher overall costs than conservative care over 12 months.
Implications: Further follow-up will determine longer-term clinical and cost-effectiveness.
Keywords: hip impingement syndrome, surgery, physiotherapist-led exercise
Funding acknowledgements: National Institute for Health Research (NIHR) Health Technology Assessment programme (grant numbers 10/41/02 and 13/103/02).
Topic: Musculoskeletal: lower limb; Orthopaedics; Rheumatology
Ethics approval required: Yes
Institution: NHS Research Ethics Service
Ethics committee: West Midlands NHS Ethics Committee
Ethics number: 14/WM/0124
All authors, affiliations and abstracts have been published as submitted.
