On the repeated-measures analysis for the entire cohort, significant predictors of the SF-36 PCS were time (P < 0.001), open versus closed fracture (P < 0.001), open versus closed by time interaction (P < 0.001), and treatment by time interaction (P = 0.04). For the SF-36 MCS, significant predictors for functional scores were time (P < 0.001) and open versus closed (P = 0.01). For the SMFA DI, significant predictors of functional scores were time (P < 0.001), open versus closed (P < 0.001), and treatment by time interaction (P = 0.03). For the SMFA BI, significant predictors of function were time (P < 0.001) and open versus closed (P < 0.001). The main effect of reamed versus unreamed nailing was not a significant predictor in any of the functional subcategories. The 95% CI for the difference of means between functional scores for reamed and unreamed nails contained zero at all time points, indicating no significant treatment effect, with the exception of the 12-month SF-36 PCS for open fractures (38.5 vs. 40.5, 95% CI, 0.15–3.89). Functional scores steadily improved over time for all fractures (Fig. 2). Tables in the Appendix (see Appendix, Supplemental Digital Content 2, http://links.lww.com/BOT/A581) provide detailed information on subgroup scores and comparisons over time.
This is the largest study of its kind to follow both open and closed tibial fractures and builds on the work of Mackenzie et al30,31 in the early 1990s using validated health outcome tools to study patient function and HRQL after lower extremity trauma. Since then, there have been multiple reports of functional outcomes after intramedullary fixation of tibia fractures,32,33 however, cohorts have often been small and assessments were limited to questions regarding knee pain or activity and employment.34,35 Court-Brown et al,16 evaluated the functional recovery of 100 patients with closed tibia fractures who were enrolled in a prospective trial of reamed versus unreamed tibial nails and found that the average time to return to work and jumping activities was approximately 11 weeks, although they did not report the proportion of those who had returned to full activity at 1 year. Similar to our study, the investigators did not find a significant difference between reamed and unreamed nails. Gaston et al11 followed 100 patients for 1 year and found that the average length of time to return to work was 13 weeks, although return to sport was much longer at 45 weeks. Neither study reported validated health outcomes measures.
Our study has a number of strengths, primarily its prospective, randomized, multicenter nature and use of standardized, validated functional outcomes tools. To our knowledge, ours is the largest study to date to report on the standardized functional outcomes after tibia fractures with well over 1000 patients enrolled. The size of this study and inclusion of both open and closed fractures provided us with large enough subgroups to meaningfully analyze multiple interactions between treatment method and type of injury. Furthermore, the diversity of locations used in this trial and use of multiple surgeons improves the generalizability of our results and their applicability to clinical practice. Our use of well-validated and widely used HRQL measures to assess both global function and the effect musculoskeletal impairment allow us to put the functional impact of tibial shaft fracture in the context of conditions not limited to the musculoskeletal system. This information can be used in the future for analyses of cost-effectiveness and the utility of health care expenditures.
Despite its strengths, our study does have some weaknesses. For example, we did not include any region-specific measures of function. However, whereas measures such as the Western Ontario and McMaster Arthritis Index or Knee Injury and Osteoarthritis Outcome Score can provide detailed information on lower extremity function, they may miss more global areas of function and do not include a psychologic component, both of which can significantly impact patient quality of life. As such, we feel our use of the SMFA appropriately captures the impact of injuries on patient-related function and health quality. Furthermore, the SMFA has been found to correlate well with functional recovery of other injuries to the lower extremity,36,37 and its widespread use allows us to put functional recovery from tibial fractures in the context of other injuries (Table 3).
Another limitation is our relatively short follow-up. Although 1 year is frequently used to assess fracture healing and surgical complications in the trauma literature, it may be inadequate to fully document functional recovery. It is clear in our cohort that, although patients steadily improved at each follow-up, physical subscores at 1 year after surgery remained significantly below their reported baseline, as well as population norms.20 Given the trajectory of their subscores, it is likely that they would have continued to improve and hopefully regained their full function with additional time. Lefaivre et al,38 were able to obtain more than 12-year follow-up of 56 patients who had suffered closed or open tibia fractures, who were treated with intramedullary nailing and found the average SF-36 and SMFA scores to be no different than population norms. However, they were unable to document at what time during follow-up, this return to function had occurred given the retrospective nature of the study. This suggests that patients with tibia fractures will eventually reach age-matched population norms in terms of global function, although recovery may be prolonged.
Although it seems that most of the recovery after tibial shaft fractures has occurred during the first year, the fact that both psychologic and physical function scores are still significantly below baseline function is sobering. These results have important implications for patient care in terms of managing both patient and physician expectations of recovery. Because health care expenditures and outcomes become scrutinized ever more closely, reliable functional outcomes data will be necessary to critically evaluate treatment efficacy.20,39 Our results provide a benchmark against which other treatment methods may be compared in the future.
1. Russell T, ed. Trauma 1. Rosemont, IL: American Academy of Orthopaedic Surgeons; 1996.
2. Schandelmaier P, Krettek C, Rudolf J, et al.. Superior results of tibial rodding versus external fixation in grade 3B fractures. Clin Orthop. 1997;342:164–172.
3. Schandelmaier P, Krettek C, Rudolf J, et al.. Outcome of tibial shaft fractures with severe soft tissue injury treated by unreamed
nailing versus external fixation. J Trauma. 1995;39:707–711.
4. Tornetta P III, Bergman M, Watnik N, et al.. Treatment of grade-IIIb open tibial fractures. A prospective randomised comparison of external fixation and non-reamed
locked nailing. J Bone Joint Surg Br. 1994;76:13–19.
5. Tu YK, Lin CH, Su JI, et al.. Unreamed
interlocking nail versus external fixator for open type III tibia fractures. J Trauma. 1995;39:361–367.
6. Busse JW, Morton E, Lacchetti C, et al.. Current management of tibial shaft fractures: a survey of 450 Canadian orthopedic trauma surgeons. Acta Orthop. 2008;79:689–694.
7. Finkemeier CG, Schmidt AH, Kyle RF, et al.. A prospective, randomized study of intramedullary
nails inserted with and without reaming for the treatment of open and closed fractures of the tibial shaft. J Orthop Trauma. 2000;14:187–193.
8. Khalily C, Behnke S, Seligson D. Treatment of closed tibia shaft fractures: a survey from the 1997 orthopaedic trauma association and osteosynthesis international-gerhard küntscher kreis meeting. J Orthop Trauma. 2000;14:577–581.
9. Larsen LB, Madsen JE, Hoiness PR, et al.. Should insertion of intramedullary
nails for tibial fractures be with or without reaming? A prospective, randomized study with 3.8 years' follow-up. J Orthop Trauma. 2004;18:144–149.
10. Nassif JM, Gorczyca JT, Cole JK, et al.. Effect of acute reamed
versus unreamed intramedullary
nailing on compartment pressure when treating closed tibial shaft fractures: a randomized prospective study. J Orthop Trauma. 2000;14:554–558.
11. Gaston P, Will E, Elton RA, et al.. Fractures of the tibia: can their outcome be predicted? J Bone Joint Surg Br. 1999;81:71–76.
12. Keating JF, O'brien PJ, Blachut PA, et al.. Locking intramedullary
nailing with and without reaming for open fractures of the tibial shaft. A prospective, randomized study. J Bone Joint Surg Am. 1997;79:334–341.
13. Keating JF, O'Brien PI, Blachut PA, et al.. Reamed
nailing of open fractures of the tibia. Clin Orthop. 1997;65:182–191.
14. Vaisto O, Toivanen J, Kannus P, et al.. Anterior knee pain after intramedullary
nailing of fractures of the tibial shaft: an eight-year follow-up of a prospective, randomized study comparing two different nail-insertion techniques. J Trauma. 2008;64:1511–1516.
15. Toivanen JA, Väistö O, Kannus P, et al.. Anterior knee pain after intramedullary
nailing of fractures of the tibial shaft a prospective, randomized study comparing two different nail-insertion techniques. J Bone Joint Surg. 2002;84:580–585.
16. Court-Brown CM, Will E, Christie J, et al.. Reamed
nailing for closed tibial fractures: a prospective study in Tscherne C1 fractures. J Bone Joint Surg. 1996;78:580–583.
17. Court-Brown CM, Gustilo T, Shaw AD. Knee pain after intramedullary
tibial nailing: its incidence, etiology, and outcome. J Orthop Trauma. 1997;11:103–105.
18. Bhandari M, Guyatt G, Tornetta P III, et al.. Randomized trial of reamed
and unreamed intramedullary
nailing of tibial shaft fractures. J Bone Joint Surg Am. 2008;90:2567–2578.
19. Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000;25:3130–3139.
20. Barei DP, Agel J, Swiontkowski MF. Current utilization, interpretation, and recommendations: the musculoskeletal function assessments (MFA/SMFA). J Orthop Trauma. 2007;21:738–742.
21. Bhandari M, Guyatt G, Tornetta P III, et al.. Study to prospectively evaluate reamed
intramedually nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design. BMC Musculoskelet Disord. 2008;9:91.
22. Keurentjes JC, Van Tol FR, Fiocco M, et al.. Minimal clinically important differences in health-related quality of life after total hip or knee replacement: a systematic review. Bone Joint Res. 2012;1:71–77.
23. Bryant D, Norman G, Stratford P, et al.. Patients undergoing knee surgery provided accurate ratings of preoperative quality of life and function 2 weeks after surgery. J Clin Epidemiol. 2006;59:984–993.
24. Stewart AL, Greenfield S, Hays RD, et al.. Functional
status and well-being of patients with chronic conditions. Results from the medical outcomes Study. JAMA. 1989;262:907–913.
25. McHorney CA, Ware JE Jr, Raczek AE. The MOS 36-Item short-form health survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993;31:247–263.
26. Busse JW, Bhandari M, Guyatt GH, et al.. Use of both short musculoskeletal function assessment questionnaire and short Form-36 among tibial-fracture patients was redundant. J Clin Epidemiol. 2009;62:1210–1217.
27. Swiontkowski MF, Engelberg R, Martin DP, et al.. Short musculoskeletal function assessment questionnaire: validity, reliability, and responsiveness. J Bone Joint Surg Am. 1999;81:1245–1260.
28. Escobar A, Quintana JM, Bilbao A, et al.. Responsiveness and clinically important differences for the WOMAC and SF-36 after total knee replacement. Osteoarthritis Cartilage. 2007;15:273–280.
29. Copay AG, Glassman SD, Subach BR, et al.. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the oswestry disability Index, Medical Outcomes Study questionnaire short form 36, and pain scales. Spine J. 2008;8:968–974.
30. MacKenzie EJ, Cushing BM, Jurkovich GJ, et al.. Physical impairment and functional
outcomes six months after severe lower extremity fractures. J Trauma. 1993;34:528–538; discussion 38–9.
31. MacKenzie EJ, Burgess AR, McAndrew MP, et al.. Patient-oriented functional
outcome after unilateral lower extremity fracture. J Orthop Trauma. 1993;7:393–401.
32. Jones M, Parry M, Whitehouse M, et al.. Radiologic outcome and patient-reported function after intramedullary
nailing: a comparison of the retropatellar and infrapatellar approach. J Orthop Trauma. 2014;28:256–262.
33. Vallier HA, Cureton BA, Patterson BM. Factors influencing functional
outcomes after distal tibia shaft fractures. J Orthop Trauma. 2012;26:178–183.
34. Kakar S, Tornetta P III. Open fractures of the tibia treated by immediate intramedullary
tibial nail insertion without reaming: a prospective study. J Orthop Trauma. 2007;21:153–157.
35. Ryan SP, Steen B, Tornetta PI. Semi-extended nailing of metaphyseal tibia fractures: alignment and incidence of postoperative knee pain. J Orthop Trauma. 2014;28:263–269.
36. Obremskey WT, Dirschl DR, Crowther JD, et al.. Change over time of SF-36 functional
outcomes for operatively treated unstable ankle fractures. J Orthop Trauma. 2002;16:30–33.
37. Egol KA, Tejwani NC, Walsh MG, et al.. Predictors of short-term functional
outcome following ankle fracture surgery. J Bone Joint Surg. 2006;88:974–979.
38. Lefaivre KA, Guy P, Chan H, et al.. Long-term follow-up of tibial shaft fractures treated with intramedullary
nailing. J Orthop Trauma. 2008;22:525–529.
39. Swiontkowski MF. Why we should collect outcomes data. J Bone Joint Surg. 2002;85:S14–S5.
40. Weening B, Bhandari M. Predictors of functional
outcome following transsyndesmotic screw fixation of ankle fractures. J Orthop Trauma. 2005;19:102–108.
41. Su EP, Westrich GH, Rana AJ, et al.. Operative treatment of tibial plateau fractures in patients older than 55 years. Clin Orthop Relat Res. 2004:240–248.
42. Sanders DW, Busam M, Hattwick E, et al.. Functional
outcomes following displaced talar neck fractures. J Orthop Trauma. 2004;18:265–270.
43. Bhattacharyya T, McCarty LP III, Harris MB, et al.. The posterior shearing tibial plateau fracture: treatment and results via a posterior approach. J Orthop Trauma. 2005;19:305–310.
44. Herscovici D Jr., Widmaier J, Scaduto JM, et al.. Operative treatment of calcaneal fractures in elderly patients. J Bone Joint Surg Am. 2005;87:1260–4.
45. Anglen JO, Burd TA, Hendricks KJ, et al.. The “Gull Sign”: a harbinger of failure for internal fixation of geriatric acetabular fractures. J Orthop Trauma. 2003;17:625–634.