Alternatives to open surgery

Evidence at a glance and key questions

We have picked three recent NIHR studies, all large clinical trials, which test alternatives to open surgery for different musculoskeletal conditions. This Highlight considers some of the key points arising from the studies, but it is not a complete review of all the evidence in this area.

Key findings

For shoulder injury

• For people aged over 50 with a long standing wear and tear injury to the shoulder, open and keyhole repair surgery gave similar outcomes and were as cost effective as each other at two years after surgery.
• Current guidance published in 2014 offers both options, although did not recommend one treatment over the other. These findings give patients and surgeons a choice based on preference and expertise, rather than cost.

Read the Signal

For upper arm fractures

• Treating a displaced fracture, near the top of the upper arm bone, with a sling worked as well as surgery to fix the broken bone and was cheaper at two years after the break. Both groups of patients (aged over 16) had physiotherapy.
• Using a sling involved fewer complications than having surgery. For frail and older people, a sling could be a much safer treatment than surgery.
• NICE guidance from 2016 (since this trial was published) now recommends non-surgical treatment provided the injury is not complicated, for example by the broken bone projecting through the skin.
• Together with the new guidance, the findings could help reverse a recent trend towards doing more operations for this injury.

Read the Signal

For ankle fractures

• For people aged over 60, with an unstable fracture to the ankle, treatment with a close contact cast may be a suitable alternative to surgery to replace the ankle joint
• NICE guidance from 2016 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. Close contact casting is a new type of conservative treatment for older people with unstable ankle fractures, and is not yet widely used outside of the trial for this purpose.

The findings do not mean that everyone with a shoulder injury, broken upper arm or unstable ankle fracture should have one treatment in favour of another - people will still need to discuss with their clinician which is the best for them.

Questions for patients

• What information can you give me about my treatment options?
• How can I get access to sufficient good quality rehabilitation to get the best out of whichever treatment I have?
• What will my recovery be like in the short term? (days and weeks)
• What will my recovery be like in the long term? (years)

Questions for healthcare professionals, such as surgeons and physiotherapists

• Can you provide information about what living with the injury is like, and how to adapt everyday tasks to make them manageable?
• Do you have information to give to patients about the treatment options and rehabilitation, that is suitable for different patients, and in different formats?
• What are the long term outcomes of different surgical treatments?
• What is the long term cost-effectiveness of rotator cuff injury treatments?

What treatments work best for certain musculoskeletal injuries?

Three recent large NIHR trials have findings that can apply to many patients. These studies help healthcare professionals and patients to make decisions when discussing the most suitable treatment options. However, healthcare professionals still need to consider what is best for individual patients.

For shoulder cuff injury

The UK Rotator Cuff Surgery trial (UKUFF)

There is little to choose between the outcomes or cost effectiveness of open surgery compared with keyhole surgery to repair shoulder cuff injury. This common shoulder injury is due to tears in rotator cuff tendons, which connect the muscles and bones in the shoulder. Damage to these tendons becomes more likely from middle age onwards, and can impair ability to carry out everyday activities.

The UK Rotator Cuff Surgery study (UKUFF) was one of the first NIHR trials to look at shoulder surgery.

The trial took place in 47 hospitals throughout the UK, involving 273 participants, who were aged over 50. Treatment success was measured by improvement of the Oxford Shoulder Score, which covers pain levels and ability to do everyday activities like dress and eat.

The main finding was that by two years after the operation, there was no difference in treatment success or costs.

The trial originally set out to evaluate a conservative treatment (rest then exercise) in addition to the two surgeries. However this was abandoned as more than three quarters of the patients in this group had surgery.

Professor Andy Carr, principal investigator for the UKUFF trial, comments on the trial and the issues involved in surgical research.

Read the Signal

For upper arm fractures

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

Treatment with a sling and active rehabilitation works as well as surgery for upper arm bone displaced fractures, but is much cheaper.

The Proximal Fracture of the Humerus: Evaluation by Randomisation (ProFHER) trial looked at a treatment for displaced fracture to the upper arm bone, a situation where the broken ends of bone are out of alignment. It compared surgery to fix the bone in position with placing the arm in a sling. Both groups of patients received physiotherapy.

We aimed, and succeeded, in getting a good standard of conservative and rehabilitation care for the trial participants,” says Professor Amar Rangan, principal investigator for the ProFHER trial. “This included good patient compliance with home exercises, which crucially was very similar in the two treatment groups. Throughout the trial we emphasised the importance of equivalent care to both surgically and non-surgically treated patients.

Non-surgical treatment with a sling is already the main treatment for humerus fractures where the bones are not displaced. When they are displaced, surgery is becoming more common. Reviews of published evidence showed uncertainty in what was best. NIHR funded this trial to address an important gap in knowledge.

The trial found that, by two years, there was no difference in treatment success between operative and conservative approaches, however the sling treatment was cheaper. Treatment success was again measured by improvement of the Oxford Shoulder Score.

This large UK trial prompted an update of the relevant Cochrane review, which was able to give a clear message to practitioners that surgery was not better for this type of fracture. This trial also informed new clinical guidelines in 2016.

Read the Signal

For ankle fracture

The Ankle Injury Management trial (AIM)

Specialist plaster casting may work as well as surgery for treating unstable ankle fractures, at less cost. There were trade-offs between the two procedures. Specialist plaster casting carried greater risk of bones not rejoining properly, whereas surgery carried greater risk of infection and wound problems. Research is continuing into costs and outcomes in the longer term, from six months to two years after the fracture.

Reviews of existing research suggested uncertainty in the management of ankle fracture. The NIHR funded this trial to find out which treatment was best for patients.

The study compared a surgical treatment with a specialised plaster cast treatment, for people aged over 60 with ankle fractures. This injury is common, but can have serious adverse impact on an older person’s ability to care for themselves.

Surgical treatment involved aligning the bone fragments and fixing them in place with plates and / or screws. The plaster cast treatment involved using a technique called close contact casting. This has been proven in the diabetes field for healing fragile skin, by distributing weight more evenly than in a conventional plaster cast.

See the trial results

Professor Keith Willett, principal investigator for the AIM trial, describes the importance of gathering patients’ views:

We carried out semi-structured interviews with patient in both arms of the trial, to look at what it meant to people having an ankle fracture at their age. We wanted to understand the sort of impact it had on their life, what it was like going into a trial and the patients thoughts about having to undergo surgery.  Many people fear anaesthesia and surgery when they’re older,while others may have had concerns about the necessity for a cast. The findings will feed into the consent process in future, because it’s important not just to help them decide which treatment to have, but to find out what it means to them as an individual.

What does the research tell us about cost effectiveness?

There are many aspects of healthcare which need to be taken into account when estimating cost effectiveness, for example cost of equipment for surgery, training costs, length of stay in hospital, risk of complications, need for follow up visits, and need for care at home.

The benefits gained by patients may offset a more expensive treatment.

From the best estimates of cost effectiveness:

• There was little to choose between the costs and benefits of open or keyhole surgery for repairing torn rotator cuff injuries, as assessed at two years after surgery.
• For fractures of the top of the arm bone, conservative treatment with a sling was more cost effective than surgical repair.

The AIM trial’s results are yet to be published, but unlike the other trials, it will include costs to carers of looking after someone at home after treatment. This is important because of the difficulty in walking during recovery from ankle fracture and the impact this has on independence.

Professor Keith Willett, principal investigator for the AIM trial, says:

An older person leaving hospital has an increased care need, which they may not be able to meet themselves. So there is often a family cost to support them, for instance in terms of home care and shopping. We calculated what else, in addition to health care costs, was required for those patients.

What do the research findings mean for patients?

The trend towards better informed patients

NICE has published specific guidance on understanding patients’ needs and helping them make decisions about treatment.

With ease of finding information on the internet, many patients now come well prepared to discuss treatment options. A large proportion expect to have a choice, in contrast to earlier decades where most expected to be told what would be done to them.

Explaining the treatment options

One of the byproducts from NIHR musculoskeletal research is to improve the way that healthcare professionals explain treatment options to patients.

An important aspect of many NIHR trials is giving the patient a better explanation of whether a certain intervention, for example surgery, would benefit them more or less than a non-operative treatment,” says shoulder surgeon Neal Millar.

In the UKUFF trial, looking at keyhole vs open surgery, patients were comfortable with there being different options once it was explained to them that we needed research to find out which approach is better. It’s also important that all the options provide a high standard of care that is clearly explained.

In the ProFHER trial, comparing surgery with sling treatment, specialist physiotherapists designed a standard approach to be followed for all the trial participants. This trial also used a patient information sheet on how to look after yourself while your broken arm was immobilised in a sling, which participants said they found helpful.

The therapeutic relationship: motivating patients to do their rehab

Treatment involving techniques, such as surgery, physiotherapy or using casts or slings to aid healing, is different to drug treatment. Instructing someone to take tablets can be done in an objective way - all the tablets for a set dose of a drug are manufactured to be identical, and the healthcare professional plays a minor role in whether the treatment works or not.

In contrast, the interaction between a surgeon, physiotherapist or other healthcare professionals is (unavoidably) part of whether the treatment works or not. Each patient needs to be educated about the condition and the treatment options, help to make a decision on which is best for them, support to have the treatment and motivating to take responsibility for doing any preparation or rehabilitation.

As a surgeon, in particular it’s our job to connect with our patients, to really explain what is expected of them after the surgery,” says Neal Millar, shoulder surgeon. “In my clinic, I commonly say to my patients that they don’t do the physio that is required of them after their shoulder surgery, I can pretty much guarantee that they will have a poor result. Because physiotherapy, and their participation in the rehab programme is so important to them getting the best surgical and patient result in the longer term.

Dr Toby Smith, physiotherapist, says:

In a programme of physiotherapy, the therapeutic relationship between the physiotherapist and the patient is particularly important. Physiotherapists clinically may ask patients to do potentially uncomfortable, repetitive or inconvenient exercises, so it is really important to be able to explain how the exercises will help and tailor them to fit into a person’s lifestyle.

What do patients think about these alternatives to open surgery?

People have different views on any treatment, and everyone's experiences are different. Here are just some of the views of patients about alternatives to open surgery, from our interviews with patients and healthcare professionals.

• Surgeons and physiotherapists agreed that to get the best result from their treatment, people need the options explaining in a way they can understand, including what it means for them. For example, explaining why they need to do their rehabilitation exercises helps motivate them to stick at it.
• A shoulder surgeon found that people may have unrealistic expectations of their treatment. All treatment can have complications, some people have higher risks than others (for example, due to co-existing conditions such as high blood pressure). No one option is suitable for everyone.
• Some trial participants with long-standing rotator cuff injuries had already had some physiotherapy or waited to see if the tendon tear would heal on its own. Many of these people asked for surgery. Few trial participants swapped between the options of treatment with a sling and surgery for upper arm bone fractures. However the time between breaking their arm to having treatment in the trial was short, less than three weeks.
• One trial participant with treated broken ankle felt that follow up should run for some years after treatment, to study long term complications.
• Another said that they were not automatically referred for physiotherapy after their shoulder surgery. Once arranged, physiotherapy really helped them. Trial and service administration should be organised so no-one misses out on parts of the treatment.

What are the challenges and where next?

What surgery or other non-medical treatments involve

Open surgery for musculoskeletal conditions includes:

• Joint replacement - where the damaged joint is completely replaced with an artificial joint.
• Repairing fully torn tendons by reattaching them to bone, or partially torn tendons by scraping off scar tissue.
• Joint fixation (surgically aligning and fixing broken bones with supportive implants such as plates or screws).

Many alternatives to open surgery have recently been investigated for relieving musculoskeletal conditions.

These include:

• Keyhole - or arthroscopic - surgery, where the repair is done through a very small cut. There is less damage to tissue compared with open surgery, but it may be less easy for the surgeon to see inside the injury.
• Conservative treatment, such as a sling (for upper arm fracture) or using an adapted plaster cast technique, such as close contact casting. Active rehabilitation is also part of the treatment.
• Physiotherapy and exercise rehabilitation, which may be used on their own, to prevent or delay a need for surgery, or before, after or with other treatments.

Some of these options are adaptations of, or new uses for, existing techniques. For example, close contact casting was originally used in the diabetes field, where skin was very fragile and difficult to heal. Other approaches, such as individually tailored physiotherapy, are more about changing how the service is provided to make it more effective.

Why we need research into techniques

We’ve known for a long time how to use research to compare the effectiveness and safety of two medicinal treatments. Drugs are manufactured to uniform high standards, and it is relatively easy to dispense them in an objective way. That means there is a lot of evidence to inform medicinal treatments.

It is more difficult to design research to compare the effects of surgery and other techniques, such as physiotherapy or using a plaster cast.

Implants (such as artificial joints) are less regulated than drugs, and there is a lack of long term research on their safety. Techniques are even more difficult to regulate or study; surgeons and other therapists are part of the treatment and so their skill and confidence are important variables; there are issues in designing a control treatment (we are only beginning to understand how to carry out ‘sham surgery’); and patients will usually be aware of which treatment they are receiving - they often cannot be ‘blinded’ as in other types of trial.

Finally, it is impossible to generalise between procedures. For example, it is not necessarily the case that minimally invasive surgery is easier, creates a smaller scar or has a shorter recovery period. We need research on each procedure and its comparators, which may well be physiotherapy, conservative treatment or a waiting list.

Professor Andy Carr, principal investigator for the UKUFF trial, comments on the difficulties of researching surgery:

The developing research field: the role of NIHR

In the last ten years, the field of research into musculoskeletal surgery and its alternatives has grown and developed. This is the result of a coordinated effort from:

• The NIHR, which encourages grant applications for surgical trials, and provides infrastructure and funds - a joined up system
• An initiative by the Royal College of Surgeons to promote research - the IDEAL collaboration and develop approaches in surgical (and other technique based) trials
• A network of collaborating research-career surgeons has been built up
• Establishing major research units, with strong collaboration (such as at the York Trials Unit, Oxford Clinical Trials Research Unit, the Warwick Clinical Trials Unit, and the Bristol Clinical Trials and Evaluation Unit).

These initiatives have helped create agreement on how to describe and standardise treatments. Surgeons have also become more familiar with the requirements for participating in research.

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.

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 CCMA, Al-Khateeb H, Verhofstad MHJ, van Laarhoven CJHM. Surgical 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 here.

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.

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.