NIHR DC Discover

NIHR Signal Two common operations to fix a broken tibia have similar outcomes

Published on 16 January 2018

doi: 10.3310/signal-000529

In people who had broken the lower part of their tibia (shin bone), fixation using a metal rod nailed to the inside of the bone was compared with a locking plate screwed onto the surface of the bone. There was no difference in the quality of life, disability or pain at 12 months for people who had fractures of the lower tibia fixed using either technique.

NICE guidance recommends that surgery takes place within 24 hours of injury but does not mandate which type of surgery to perform. This NIHR UK-based trial was funded to find which treatment was better for lower tibial fractures.

During the trial, some people expressed a preference for one operation over the other and surgeons were generally more in favour of the nail fixation.

The findings suggest that surgeons should continue using their judgement to decide which surgical approach is best, in discussion with the patient.

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Why was this study needed?

Fractures of the tibia near the ankle can be difficult to treat because the bone lies so close to the skin.

Surgery aims to realign the ends of the broken bone and then to hold them securely in place while they heal. There is uncertainty whether fixing a rod inside the bone using nails is better or worse than a locking plate screwed onto the surface of the bone.

Both operations have downsides – the rod can break, whereas plates require a larger incision, which can increase the risk of infection. This UK trial compared the two techniques in people with a distal tibial fracture that had not penetrated the skin or involved the ankle joint.

What did this study do?

This UK FixDT randomised controlled trial included 321 people aged 16 or over (average age 45), with a distal tibial fracture admitted to any one of 28 UK trauma hospitals.

The type of surgical procedure was randomly decided in advance. Surgeons had flexibility in how they performed the surgery: for example, how many screws they used. A small number of patients did not receive the surgery they were allocated due to the surgeon’s overriding clinical judgment. However overall 91% of patients received the treatment to which they had been allocated.

It was not possible to blind patients or surgeons to the type of surgery, but the team treating them and the people assessing their outcomes were unaware of which surgical procedure they had undergone. This trial was well-conducted, and we can have confidence in the findings.

What did it find?

  • At three months people who received nail fixation had a better average Disability Rating Index (DRI) score (44.2, 95% confidence interval [CI] 40.8 to 47.6) compared with people who received a locking plate (52.6, 95% CI 49.3 to 55.9). This resulted in a clinically meaningful adjusted difference of 8.8 points (95% CI 4.3 to 13.2). The DRI is a 100-point scale, from 0 (no disability) to 100 (complete disability).
  • At six months people in the nail fixation group had lower average DRI scores (29.8, 95% CI 26.0 to 33.7) compared with the locking plates group (33.8, 95% CI 29.7 to 37.9) but the adjusted difference of 4.0 between the groups was not clinically meaningful (95% CI ‑1.6 to 9.0).
  • At twelve months DRI scores were similar in the nail fixation (23.1, 95% CI 18.9 to 27.2) and locking plate (24.0, 95% CI 19.7 to 28.3) groups. Again the adjusted difference of 1.9 was not clinically significant (95% CI ‑3.2 to 6.9).
  • There was no difference by 12 months in scores for quality of life (measured using the EuroQol Health-Related Quality-of-Life 3-Level score, EQ-5D-3L) or pain or function (Olerud-Molander Ankle Score, OMAS).

What does current guidance say on this issue?

There is no guidance on surgical technique for distal tibial fractures which do not involve the ankle joint.

What are the implications?

This UK-based trial suggests that disability, quality of life and pain up to 12 months after surgery are similar for nail fixation and locking plate fixation in people with an acute distal tibial fracture.

Practical considerations such as the type of fracture or soft tissue damage may still influence the surgeon’s judgment regarding the choice of surgery; it would be useful to understand the reasons given for changing approaches in this trial. Some people were excluded from the trial because they expressed a strong preference for one operation over the other. This suggests that there may be other factors for surgeons to consider when discussing the options with their patients to reach a shared decision about how best to proceed.

In the interim, it is useful to know that – contrary to expectations – long-term outcomes were similar.

Citation and Funding

Costa M, Achten J, Griffin J et al. Effect of locking plate fixation vs intramedullary nail fixation on 6-month disability among adults with displaced fracture of the distal tibia. The UK FixDT randomized clinical trial. JAMA. 2017;318(18):1767-76.

This project was funded by the NIHR Health Technology Assessment Programme (project number 11/136/04) and was supported by the NIHR Oxford Biomedical Research Centre and the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health National Health Service (NHS) Foundation Trust.

Bibliography

NICE. Fractures (complex): assessment and management. NG37. London: National Institute for Health and Care Excellence; 2016.

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

Why was this study needed?

Fractures of the tibia near the ankle can be difficult to treat because the bone lies so close to the skin.

Surgery aims to realign the ends of the broken bone and then to hold them securely in place while they heal. There is uncertainty whether fixing a rod inside the bone using nails is better or worse than a locking plate screwed onto the surface of the bone.

Both operations have downsides – the rod can break, whereas plates require a larger incision, which can increase the risk of infection. This UK trial compared the two techniques in people with a distal tibial fracture that had not penetrated the skin or involved the ankle joint.

What did this study do?

This UK FixDT randomised controlled trial included 321 people aged 16 or over (average age 45), with a distal tibial fracture admitted to any one of 28 UK trauma hospitals.

The type of surgical procedure was randomly decided in advance. Surgeons had flexibility in how they performed the surgery: for example, how many screws they used. A small number of patients did not receive the surgery they were allocated due to the surgeon’s overriding clinical judgment. However overall 91% of patients received the treatment to which they had been allocated.

It was not possible to blind patients or surgeons to the type of surgery, but the team treating them and the people assessing their outcomes were unaware of which surgical procedure they had undergone. This trial was well-conducted, and we can have confidence in the findings.

What did it find?

  • At three months people who received nail fixation had a better average Disability Rating Index (DRI) score (44.2, 95% confidence interval [CI] 40.8 to 47.6) compared with people who received a locking plate (52.6, 95% CI 49.3 to 55.9). This resulted in a clinically meaningful adjusted difference of 8.8 points (95% CI 4.3 to 13.2). The DRI is a 100-point scale, from 0 (no disability) to 100 (complete disability).
  • At six months people in the nail fixation group had lower average DRI scores (29.8, 95% CI 26.0 to 33.7) compared with the locking plates group (33.8, 95% CI 29.7 to 37.9) but the adjusted difference of 4.0 between the groups was not clinically meaningful (95% CI ‑1.6 to 9.0).
  • At twelve months DRI scores were similar in the nail fixation (23.1, 95% CI 18.9 to 27.2) and locking plate (24.0, 95% CI 19.7 to 28.3) groups. Again the adjusted difference of 1.9 was not clinically significant (95% CI ‑3.2 to 6.9).
  • There was no difference by 12 months in scores for quality of life (measured using the EuroQol Health-Related Quality-of-Life 3-Level score, EQ-5D-3L) or pain or function (Olerud-Molander Ankle Score, OMAS).

What does current guidance say on this issue?

There is no guidance on surgical technique for distal tibial fractures which do not involve the ankle joint.

What are the implications?

This UK-based trial suggests that disability, quality of life and pain up to 12 months after surgery are similar for nail fixation and locking plate fixation in people with an acute distal tibial fracture.

Practical considerations such as the type of fracture or soft tissue damage may still influence the surgeon’s judgment regarding the choice of surgery; it would be useful to understand the reasons given for changing approaches in this trial. Some people were excluded from the trial because they expressed a strong preference for one operation over the other. This suggests that there may be other factors for surgeons to consider when discussing the options with their patients to reach a shared decision about how best to proceed.

In the interim, it is useful to know that – contrary to expectations – long-term outcomes were similar.

Citation and Funding

Costa M, Achten J, Griffin J et al. Effect of locking plate fixation vs intramedullary nail fixation on 6-month disability among adults with displaced fracture of the distal tibia. The UK FixDT randomized clinical trial. JAMA. 2017;318(18):1767-76.

This project was funded by the NIHR Health Technology Assessment Programme (project number 11/136/04) and was supported by the NIHR Oxford Biomedical Research Centre and the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health National Health Service (NHS) Foundation Trust.

Bibliography

NICE. Fractures (complex): assessment and management. NG37. London: National Institute for Health and Care Excellence; 2016.

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

Effect of Locking Plate Fixation vs Intramedullary Nail Fixation on 6-Month Disability Among Adults With Displaced Fracture of the Distal Tibia. The UK FixDT Randomized Clinical Trial

Published on 14 November 2017

M Costa, J Achten, J Griffin

JAMA , 2017

Importance The best treatment for fractures of the distal tibia remains controversial. Most such fractures require surgical fixation but outcomes are unpredictable and complications are common. Objective To assess disability, quality of life, and complications in patients with displaced tibial fracture treated with intramedullary nail fixation vs locking plate fixation. Design, Setting, and Participants A multicenter randomized trial recruiting 321 patients 16 years or older with an acute, displaced, extra-articular fracture of the distal tibia from April 2013 through April 2016 with final follow-up in February 2017. Exclusion criteria included open fractures, fractures involving the ankle joint, contraindication to nailing, or inability to complete questionnaires. Interventions Intramedullary nail fixation (nail group; n = 161), a metal rod inserted into the hollow center of the tibia, vs locking plate fixation (plate group; n = 160), a plate attached to the surface of the tibia with fixed-angle screws. Main Outcomes and Measures Disability Rating Index (DRI; score range, 0 [no disability] to 100 [complete disability]) at 6 months was the primary outcome measure, with a minimal clinically important difference of 8 points. DRI measurement was also collected at 3 and 12 months. Secondary outcomes were the Olerud-Molander Ankle Score (OMAS), quality of life, and complications (such as infection and further surgery). Results Among 321 randomized patients (mean age, 45 years [SD, 16.2]; men, 197 [61%]; had experienced traumatic injury after a fall, 223 [69%]), 258 completed the study. There was no statistically significant difference in the DRI score at 6 months between groups (mean score, 29.8 in the nail group vs 33.8 in the plate group; adjusted difference, 4.0 [95% CI, −1.0 to 9.0], P = .11). There was a statistically significant difference in the DRI score at 3 months in favor of nail fixation (mean score, 44.2 in the nail group and 52.6 in the plate group; adjusted difference, 8.8 [95% CI, 4.3 to 13.2], P < .001), but not at 12 months (mean score, 23.1 in the nail group and 24.0 in the plate group; adjusted difference, 1.9 [95% CI, −3.2 to 6.9], P = .47). Secondary outcomes showed the same pattern, including a statistically significant difference in mean OMAS at 3 and 6 months in favor of nail fixation. There were no statistically significant differences in complications, including the number of postoperative infections (9% in the nail group vs 13% in the plate group). Further surgery was more common in the plate group at 12 months (8% in nail group vs 12% in plate group). Conclusions and Relevance Among patients 16 years or older with an acute, displaced, extra-articular fracture of the distal tibia, neither nail fixation nor locking plate fixation resulted in superior disability status at 6 months. Other factors may need to be considered in deciding the optimal approach.

Expert commentary

Most non-articular fractures of the lower tibia need surgical fixation, but the best method of fixation remains unclear. The two main types of fixation are either a medullary rod or a plate with screws.

The large randomised trial of adults with lower tibial fractures compared the clinical outcomes between the two modes of fixation. Although the Disability Rating Index was significantly superior in patients treated by a medullary rod at three months, there was no difference in any outcome measure by six months.

As both methods produce similar outcomes, surgeons may select a method based on other factors such as those relating to local soft-tissues.

Michael Pearse, Clinical Senior Lecturer and Consultant Orthopaedic Surgeon, Imperial College London