Journal Club

Presented byMaj. Dr. Dipendra Maharjan

Introduction• Intertrochanteric femoral fractures are often seen in the 6th and 8th decades

and associated with morbidity, decrease in daily functions, and mortality in elderly patients.

– S. J. Jacobsen, J. Goldberg, T. P. Miles, J. A. Brody, W. Stiers, and A. A. Rimm, “Hip fracture incidence among the old and very old: a population-based study of 745,435 cases,” American Journal of Public Health, vol. 80, no. 7, pp. 871–873, 1990.

• Mortality rates range from 15% to 30%

– S.Boonen,P.Autier,M.Barette,D.Vanderschueren,P.Lips,and P. Haentjens, “Functional outcome and quality of life following hip fracture in elderly women: a prospective controlled study,” Osteoporosis International, vol. 15, no. 2, pp. 87–94, 2004.

• surgical treatment and early weight bearing are regarded as the standard approach

– S. T. Canale, Campbell’s Operative Orthopaedics, vol. 3, Gu ne s Tıp Kitabevleri, 11th edition, 2011, Turkish Translation Edited by M. Basbozkurt, C. Yıldız. ̈ ̧

Zoledronic Acid

• a potent bisphosphonate used in the treatment of osteoporosis.

• Especially used in the treatment of hip and vertebral fractures due to osteoporosis in postmenopausal women– J. Melton and C. Cooper, “Magnitude and impact of osteoporo- sis and fractures,” in Osteoporosis, R. Marcus, D. D. Feldman, and J. Kelsey, Eds., vol.

1, pp. 557–567, Academic Press, San Diego, Calif, USA, 2001.

• Shown in clinical studies to accelerate fracture healing and to inhibit the formation of new fractures– M. J. Gardner, R. H. Brophy, D. Demetrakopoulos et al., “Interventions to improve osteoporosis treatment following hip fracture: a prospective,

randomized trial,” e Journal of Bone & Joint Surgery—American Volume, vol. 87, no. 1, pp. 3–7, 2005.

Clinical question• Population

– 120 eldery patients with intertrochanteric fracture

• Intervention– Treatment group (received zoledronic acid 5mg post operatively)

• Comparison– Placebo group (Normal saline)

• Outcome– Zoledronic acid after treatment of hip fracture in elderly is a safe

treatment modality.

Participants• Key selection criteria

– Elderly 65 years old or above intertrochanteric fracture

• Excluding criteria– Age below 65 years– Pathological fractures– Being bedridden prior to the fracture– Any disease contraindicated to zoledronic acid– Any disease that creates more than two comorbidities– Trauma other than falling– Additional fractures to intertrochanteric femur fracture

• Inclusion/exclusion criteria suitable for the study

• Study type– Prospective controlled randomized

• Study population– Enrolled were all elderly 65 years old or above with intertrochanteric

fracture

• Randomization– Patients were consecutively divided into 2 groups according to the

sequential order of arrival and the first patient was included in treatment group

• Bias– Exposed– Randomization– Not blinded to reduce experimental bias

Intervention and comparison• Prospective, controlled, randomized clinical study

• 120 elderly intertrochanteric fractures enrolled who underwent surgical osteosynthesis

• Received 1200mg of calcium carbonate and 1000IU Vitamin D

• Treatment group received 5mg zoledronic acid

• The study period was between the years 2012 and 2013

• During their time period of study– 60 patients in each group– 4 from treatment group and 2 from placebo group were

excluded

• All patients underwent surgical osteosynthesis and intretrochanteric antegrade nail (INTERTAN)

• All patients were mobilized with walker for postoperative 6 weeks

Methodology• The number of the patients was figured out by 95% confidence

level and power analysis to decrease mortality rates from 25% to 15% and 55 patients were determined for each group.

• Categorical data were analyzed by using chi-square test.

• Variations of functional scores in intragroup and intergroup combinations were compared with repeated ANOVA and post hoc Bon- ferroni method.

• Group mean survival times were estimated with Kaplan-Meier method.

• Comparison of mean survival times was investigated with Log-Rank test.

• Quantitative characteristics of the two groups were analyzed by -test, for independent groups in terms of mean 𝑡comparisons.

• Cox regression model was used to show which of multiple factors had significant effect on mortality.

• IBM-SPSS 20 program was used for analysis.

• In all tests, the level of significance was adjusted to 0.05.

Methodology– Method and approach to the study were diligent

– Process was consistent

– Follow complete in both the groups

– Outcome measures and appropriate

– Statistical tools used were suitable and correctly interpreted

Results

Average merle d’Aaubigne score at 12 months was 14.58 in treatment group and 12.68 at control group.

Good results were achieved in treatment group as well as in controlled group

The average HSS was 81,93 in treatment group at the end of postoperative 1st year, it was found to be 72.9 in control group.

While 83.4% (40/48) excellent and very good results were achieved in treatment group, 57.9% (22/38) excellent and very good results were obtained in control group

Zoledronic acid was determined to provide significant increase at the bone mineral density

The mortality rate of 114 patients with mean follow up time of 9.54 months has been found to be 24.5%

In terms of functional results, Harris hip score and Merle d’Aubigne score showed parallelism and remained consistently higher in the treatment group from the 6th week.

Discussion and interpretation• Strength and weakness of the study

– All patients underwent the surgical procedure in a single institution, in which they were given standard• their perioperative care• The type of anesthesia, • fixation mode• rehabilitation protocol, • pain management, • perioperative antibiotics• Postoperative management

• Strength and weakness of the study

– The study only evaluated the incidence of clinically important unstable intertrochanteric fracture

– Only used zoledronic acid for the treatment of osteoporosis

– Prospective, Radomized controlled clinical study

– Underwent osteosynthesis, • unable to mention the duration of operation, • operating surgeon, • need for blood transfusion

• Strength and weakness of the study– Low number of patients

– Did not used any radiological scoring

– Inability to assess joining time

– The groups being nonhomogenous because of dying patients

– They were unable to determine the exact cause of death

– They pointed out that the death occurred in the first 3 months in both group

– emphasized on the need of further investigation.

Clinical Context

• Why not we start using zoledronic acid postoperatively?– Common in our population– Frequently treat elderly with intertrochanteric fracture– Literature has shown

• Mortality occurs in first 3 months• Zoledronic acid use decreases the mortality rate

– We need our own study.

Conclusion

The use of zoledronic acid after surgical treatment of intertrochanteric femoral fractures in osteoporotic over 65 year

old patients is a safe treatment modality

Thank you!!!