Complications in Canine Cranial Cruciate Ligament Surgery. Ron Ben-Amotz
NNH is calculated similar to NNT but with complication frequencies. When calculating NNH, a specific complication(s) needs to be selected. For example, if surgery A had an infection rate of 10% and surgery B had an infection rate of 0%, the NNH would be 10. This means that one more infection would be seen for surgery A after completing 10 surgeries. A target NNH depends on the severity of the complication being assessed. A single‐digit NNH may be acceptable for a minor complication such as incisional redness compared to a NNH of 100 for a major complication like implant infection.
For both NNT and NNH, it is also important to evaluate the overall frequency of success, or a complication, to direct clinical decision making. For example, if the NNH is 10 but the overall frequency of infection is 90% vs 80%, a clinician may conclude neither procedure should be used.
Finally, likelihood to be helped or harmed (LHH) can be calculated (NNH:NNT). A number >1 tells us that the treatment is that many times more likely to help than to harm. Using the above example, surgery A has a LHH of 10/13 = 0.77. When the LHH is <1, the treatment is more likely to harm than to help. A LHH <1 is usually only acceptable when the complication assessed is minor or transient. The more serious the complication assessed, the higher the desired LHH.
Other considerations when discussing complications include the effect of duration of follow‐up and unique complications to the procedure. Time after an intervention can influence success and complication rate; a longer follow‐up period may allow for an improved treatment response but also allows for a greater opportunity for an unintended outcome, like OA. In veterinary orthopedics, 12 months has been defined as the length of “long‐term” follow‐up; this terminology is reasonable but has been inconsistently followed [27].
It is important that statistical and clinical significance is considered when designing a study and interpreting results. Statistical significance is an important scientific evaluation of a dataset, but it is important to remember that it may be of little or no value when considering the care of an individual patient [29, 30]. One consideration is that investigations that include large sample sizes can result in clinically unimportant variables gaining statistical significance.
Although a p value is a common method to inform us of a statistical difference between groups, effect size and minimal clinically important difference (MCID) should also be investigated. Effect size helps quantify the magnitude of the difference observed and is not influenced by sample size. It is calculated by finding the difference between the means of two groups and dividing the result by the standard deviation [31]. Cohen suggested 0.2 is a small effect size, 0.5 is an average effect size, and 0.8 is a large effect size. For perspective, when there is an effect size of 0.8, 79% of the treatment group will be above the mean of the control group (a reference chart can provide this information for all effect size values).
Minimal clinically important difference was defined as “the smallest difference in score in the domain of interest which patients perceive as beneficial and which would mandate, in the absence of troublesome side effects and excessive cost, a change in the patient's management” [32] which was later simplified to “the smallest change that is important to patients” [33]. Although many human studies use patient‐reported outcomes to define MCID, it is often compared to objective data. The major limitations of MCID include inconsistent definitions or values for MCID, cost of treatment not being taken into consideration, and MCID often varies depending on the baseline (more severely affected patients often need a smaller improvement to be pleased with the outcome). Alternative methods to put datasets into context include utilizing confidence intervals and probability. Regardless of the statistical methods used, they should be considered prior to the onset of a study so investigators remain unbiased. Unfortunately, most veterinary journals, reviewers, and investigators rely solely on the p value to determine significance, limiting thorough evaluation of different interventions.
References
1 1. Arnoczky, S.P. and Marshall, J.L. (1977). The cruciate ligaments of the canine stifle: an anatomical and functional analysis. Am. J. Vet. Res. 38: 1807–1814.
2 2. Tanegashima, K., Edamura, K., Akita, Y. et al. (2019). Functional anatomy of the craniomedial and caudolateral bundles of the cranial cruciate ligament in beagle dogs. Vet. Comp. Orthop. Traumatol. 32: 182–191.
3 3. Wilke, V.L., Robinson, A., Evans, R.B. et al. (2005). Estimate of the annual economic impact of treatment of the cranial cruciate ligament injury in dogs in the United States. J. Am. Vet. Med. Assoc. 227: 1604–1607.
4 4. Witsberger, T.H., Villamil, J.A., Schultz, L.G. et al. (2008). Prevalence of and risk factors for hip dysplasia and cranial cruciate ligament deficiency in dogs. J. Am. Vet. Med. Assoc. 232: 1818–1824.
5 5. Vezzoni, A., Bohorquez Vanelli, A., Modenato, M. et al. (2008). Proximal tibial epiphysiodesis to reduce tibial plateau slope in young dogs with cranial cruciate ligament deficient stifle. Vet. Comp. Orthop. Traumatol. 21: 343–348.
6 6. Muir, P., Schwartz, Z., Malek, S. et al. (2001). Contralateral cruciate survival in dogs with unilateral non‐contact cranial cruciate ligament rupture. PLoS One 10: e25331.
7 7. Morris, E. and Lipowitz, A.J. (2001). Comparison of tibial plateau angles in dogs with and without cranial cruciate ligament injuries. J. Am. Vet. Med. Assoc. 218: 363–366.
8 8. Cook, J.L. (2010). Cranial cruciate ligament. Disease in dogs: biology versus biomechanics. Vet. Surg. 39: 270–277.
9 9. Hayashi, K., Manley, P.A., and Muir, P. (2004). Cranial cruciate ligament pathophysiology in dogs with cruciate ligament disease: a review. J. Am. Anim. Hosp. Assoc. 40: 385–390.
10 10. Kuroki, K., Williams, N., Ikeda, H. et al. (2019). Histologic assessment of ligament vascularity and synovitis in dogs with cranial cruciate ligament disease. Am. J. Vet. Res. 80: 152–158.
11 11. DeCamp, C.E., Riggs, C.M., Olivier, N.B. et al. (1996). Kinematic evaluation of gait in dogs with cranial cruciate ligament rupture. Am. J. Vet. Res. 57: 120–126.
12 12. Budsberg, S.C., Verstraete, M.C., Soutas‐Little, R.W. et al. (1988). Force plate analysis before and after stabilization of canine stifles for cruciate injury. Am. J. Vet. Res. 46: 1522–1524.
13 13. O'Connor, B.L., Visco, D.M., Heck, D.A. et al. (1989). Gait alterations in dogs after transection of the anterior cruciate ligament. Arthritis Rheum. 32: 1142–1147.
14 14. Korvick, D.L., Pijanowski, G.J., and Schaeffer, D.J. (1994). Three‐dimensional kinematics of the intact and cranial cruciate ligament‐deficient stifle of dogs. J. Biomech. 27: 77–87.
15 15. Tashman, S., Aderst, W., Kolowich, P. et al. (2004). Kinematics of the ACL‐deficint canine knee during gait: serial changes over two years. J. Orthop. Res. 22: 931–941.
16 16. Rey, J., Fischer, M.S., and Bottcher, P. (2014). Sagittal joint instability in the cranial cruciate ligament insufficient canine stifle. Caudal slippage of the femur and not cranial tibial subluxation. Tierarztl. Prax. Ausg. K. Kleintiere Heimtiere 42: 151–156.
17 17. Schaible, M., Shani, J., Ben‐Amotz, R. et al. (2017). Combined tibial plateau leveling osteotomy and lateral fabellotibial suture for cranial cruciate ligament rupture with severe rotational instability. J. Small Anim. Pract. 58 (4): 219–226.
18 18. Whitehair, J.G., Vasseur, P.B., and Willits, N.H. (1993). Epidemiology of cranial cruciate ligament rupture in dogs. J. Am. Vet. Med. Assoc. 203: 1016–1019.
19 19. Duval, J.M., Budsberg, S.C., Flo, G.L. et al. (1999). Breed, sex, and body weight as risk factors for rupture of the cranial cruciate ligament in young dogs. J. Am. Vet. Med. Assoc. 215: 811–814.
20 20. Marcellin‐Little, D.J. and Levine, D. (2015). Principles and application of range of motion and stretching in companion animals. Vet. Clin. North Am. Small Anim. Pract. 45: 57–72.
21 21. Neal, B., Ting, D., Bonczynski, J. et al. (2015). Evaluation of meniscal click for detecting meniscal tears in stifles with cranial cruciate ligament disease. Vet. Surg. 44: 191–194.
22 22. Gleason, H., Hudson, C., and Cerroni, B. (2020). Meniscal