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About the research on alternatives to surgery

This Highlight draws on the findings of the following NIHR research studies:

The UK Rotator Cuff Surgery (UKUFF) randomised trial (UKUFF)

Carr AJ, Cooper CD, Campbell MK, et al. Clinical effectiveness and cost-effectiveness of open and arthroscopic rotator cuff repair [the UK Rotator Cuff Surgery (UKUFF) randomised trial]. Health Technol Assess. 2015;19(80):1-218.

UKUFF trial website: https://www.situ.ox.ac.uk/surgical-trials/ukuff

The ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial (ProFHER)

Rangan A, Handoll H, Brealey S, et al. Surgical vs Nonsurgical Treatment of Adults With Displaced Fractures of the Proximal Humerus: The PROFHER Randomized Clinical Trial. JAMA. 2015;313(10):1037-47.

Handoll H, Brealey S, Rangan A, et al. The ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial - a pragmatic multicentre randomised controlled trial evaluating the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment for proximal fracture of the humerus in adults. Health Technol Assess. 2015 Mar;19(24):1-280.

Handoll HH, Goodchild L, Brealey SD, et al. Developing, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial. Bone and Joint Research. 2014 Dec 1;3(12):335-40.

For the updated Cochrane review featuring this trial, see:

Handoll HHG, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database of Systematic Reviews 2015, Issue 11. Art. No.: CD000434. DOI: 10.1002/14651858.CD000434.pub4.

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008470.pub2/full

Other relevant reviews relating to orthopaedic surgery for musculoskeletal injuries can be found at the Cochrane review group resources http://bjmt.cochrane.org 

The Ankle Injury Management trial (AIM)

Willett K, Keene DJ, Morgan L, et al. Ankle Injury Management (AIM): design of a pragmatic multi-centre equivalence randomised controlled trial comparing Close Contact Casting (CCC) to Open surgical Reduction and Internal Fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years. BMC musculoskeletal disorders. 2014 Mar 12;15(1):1.

 

Willett K, Keene DJ, Mistry D, et al. Close contact casting vs surgery for initial treatment of unstable ankle fractures in older adults: a randomized clinical trial. JAMA. 2016;316(14):1455-63. 

Keene DJ, Mistry D, Nam J, et al.The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years. Health Technol Assess 2016;20(75)

 

AIM trial website: http://www.aimtrial.org/

For the Cochrane review identifying uncertainty in treatment options (and the need for AIM trial), see

Donken CCMAAl-Khateeb HVerhofstad MHJvan Laarhoven CJHMSurgical versus conservative interventions for treating ankle fractures in adults. Cochrane Database Syst Rev. 2012;(8):CD008470. 

NIHR Signals

The two published studies are available as NIHR Signals.

Little to choose between open and keyhole surgery as options for repairing shoulder rotator cuff tears. 1 December 2015.

Surgery is no more effective than a sling for misaligned shoulder fractures. 11 March 2015.

You can see more signals on other topics on the NIHR Discover portal.

How does the research fit with current guidance?

Existing US and UK guidance offers open or keyhole surgery as options to repair rotator cuff tendons, but has not found sufficient evidence to recommend one approach in favour of the other. Large scale, pragmatic research is needed to investigate benefits and costs of the different options.

NICE guidance published in 2016 since the ProFHER trial now recommends non-surgical treatment as the best approach for treating displaced fractures of the upper arm bone. At the time, evidence was needed from a large trial on the best, most cost effective approach to use.

The same NICE guidance recommends non-surgical treatment for some types of ankle fracture where there is a single break, but also mentions surgery as an option for ankle fractures in general.

References

AAOC. Optimizing the management of rotator cuff problems. Rosemont (IL): American Academy of Orthopedic Surgeons; 2010.

BESS, BOA, RCSEng. Commissioning guide 2014. Subacromial shoulder pain. London: British Elbow & Shoulder Society (BESS), British Orthopaedic Association (BOA), Royal College of Surgeons for England (RCSEng); 2014.

NICE. Fractures (non-complex): assessment and management. NG38. London: National Institute for Health and Care Excellence; 2016.

NIHR research in progress

This section points you towards NIHR funded research on alternatives to open surgery for musculoskeletal conditions.

There are other NIHR studies that have some relevance to the topic – you can find out more at nihr.ac.uk or www.journalslibrary.nihr.ac.uk.

Publication of the Ankle Injury Management trial (AIM)

The Ankle Injury Management trial has now finished, and the results are expected in Autumn 2016.

There is more information about AIM at http://www.aimtrial.org/

The UK Frozen Shoulder Trial (UK FROST)

Frozen shoulder is a painful and disabling condition where tissue in the shoulder becomes inflamed and scarred. It may get better by itself after one to three years, or it may persist.

The UK Frozen Shoulder Trial (UK FROST) is comparing the effects of physiotherapy alone with two types of surgery. One types is manipulation of the arm under anaesthetic and the other is keyhole release of the scarred tissue. The results will make clearer the role of physiotherapy in treating frozen shoulder.

This NIHR-funded study built on experiences from the ProFHER study, such as need for a detailed pilot study, and the research design expertise of the York Trials Unit. There is more information about UK FROST at http://www.york.ac.uk/healthsciencethios s/research/trials/research/trials/ukfrost/.

The UK Full Randomised Controlled trial of Arthroscopic Surgery for Hip Impingement versus best CoNventional trial (FASHIoN)

Hip impingement is discomfort caused by small deformities in the hip joint.

The UK Full Randomised Controlled trial of Arthroscopic Surgery for Hip Impingement versus best CoNventional trial is comparing physiotherapy with keyhole surgery to treat this condition.

There is more information about FASHIoN at http://www2.warwick.ac.uk/fac/med/research/csri/orthopaedics/research/fulllist/fashion/

Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT)

Fracture of the small bones in the wrist is a common injury among young, active people. Scaphoid Waist Internal Fixation for Fractures Trial is comparing cast treatment with surgical fixation to treat these fractures.

There is more information about SWIFFT at https://www.journalslibrary.nihr.ac.uk/programmes/hta/113637/#/ and https://www.makingresearchbetter.co.uk/clinical-research/injuries-and-emergencies/swifft-trial/

Further information

Dawson J, Fitzpatrick R, Carr A. Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br. 1996;78(4):593–600.

Dawson J, Rogers K, Fitzpatrick R, Carr A. The Oxford Shoulder Score revisited. Arch Orthop Trauma Surg. 2009;129(1):119–23.

Isis Innovation Ltd. The Oxford Shoulder Score (OSS). Oxford; undated.

Neer II, CS. Displaced proximal humeral fractures. Part I. Classification and evaluation. J Bone Joint Surg Am. 1970;52:1077-1089.

Neer II, CS. Displaced proximal humeral fractures. Treatment of three-part and four-part displacement. J Bone Joint Surg Am. 1970;52:1090-1103.

NHS Choices. Broken ankle. London: Department of Health; updated 2015.

NHS Choices. Broken arm or wrist. London: Department of Health; updated 2015.

NHS Choices. Shoulder pain. London: Department of Health, updated 2014.

Payne, J. Rotator cuff disorders. Leeds; Patient; 2015.

Zhi M, Lihai Z, Licheng Z, et al. Operative versus nonoperative treatment in complex proximal humeral fractures. Orthopedics. 2014;37(5):e410-e9.

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