Functional Outcome After Dual Mobility Cups Total Hip Replacement Versus Bipolar Hemiarthroplasty in Fracture Neck of Femur in Active Elderly Patients
Phase: NA
Conditions: Fracture Neck of Femur
Sponsor: Ain Shams University

                                                                                                                            
 
MDThesis/MFA/ISRO/FacultyofMedicine/ASU 
1 
 
Protocol of a Thesis for partial fulfillment of 
M.D. degree of Orthopedic Surgery 
4 September 2018  
Title of the protocol: Functional outcome after Dual mobility cups 
total hip replacement versus Bipolar hemiarthroplasty in fracture 
neck of femur in active elderly patients. 
 
Post graduate student: Tony Maher Makeen Mousa  
Degree: Master degree of orthopedic surgery  
 
Director: Professor Ibrahim Mostafa El Ganzoury 
Academic position: Professor  
Department: orthopedic surgery  
 
Co-director: Professor Haytham Abdelazim Mohamed  
Academic position: Assistant professor  
Department: orthopedic surgery  
 
Co-director: Dr. Waleed El Sayed Abdelaleem El Shabrawy    
Academic position: Lecturer  
Department: orthopedic surgery 
 
Co-director: Dr. Ahmed Mohamed Mohasseb 
Academic position: lecturer  
Department: orthopedic surgery  
 
Co-director: Dr. Mostafa Mamdouh Ashoub    
Academic position: Lecturer  
Department: orthopedic surgery 

                                                                                                                            
 
MDThesis/MFA/ISRO/FacultyofMedicine/ASU 
2 
 
 
What is already known about this subject?  
What does this study add? 
The decision to perform arthroplasty in patients with a femoral neck fracture is 
currently not well standardized. The choice between performing total hip 
arthroplasty or hemiarthroplasty is not straightforward in older patients with 
femoral neck fracture, particularly when co-morbidities are factored in.(1) This 
led us to carry out this comparative study between Dual mobility cups total hip 
replacement and bipolar hemiathroplasty to reveal the functional and 
mechanical outcome of each.  
 
 
 
1.Introduction/Review  
Femoral neck fractures in the elderly are frequent, represent a great health care 
problem, and have a significant impact on health insurance costs.(2) A typical 
patient with fracture neck of femur is characterized by old age, severe 
osteoporosis and significant co-morbid diseases. Fracture neck of femur has 
always been a great challenge to the orthopedic surgeon.(3) 
The primary aim of treatment should be to perform a surgery that provides the 
patient with the greatest opportunity for early ambulation. This requirement is 
fulfilled to a great extent by the use of a primary prosthetic replacement. 
Reconstruction options using hip arthroplasty include bipolar hemiarthroplasty 
(HA), and total hip arthroplasty (THA) & Dual mobility cups total hip 
replacement (DMTHA).(4) 
Bipolar hemiarthroplasty (HA) has long been the preferred treatment, and is 
performed in75% of cases. It is justified by the reasonable operating time, low 
blood loss and acceptable functional outcomes. In the 2000s, total hip 
arthroplasty (THA) emerged as a relevant alternative to HA. Since then, there is 
an on-going debate on the best implant to use. Age, co-morbidities, patient 
independence and potential surgical complications must be taken into account 
when deciding between implants.(5) The risk of dislocation is a key deciding 
factor because of its well-described consequences. Up to the early 2010s, the 
THA procedures described in the studies used a fixed cup. In some cases, this 

                                                                                                                            
 
MDThesis/MFA/ISRO/FacultyofMedicine/ASU 
3 
 
resulted in the dislocation rate being higher than with HA. The emergence of 
dual mobility (DM) cups has reduced the dislocation rate.(6) However, the 
relative role of DMTHA and HA is not well defined in the context of co-
morbidities and functional outcome.(7) 
 
 
2.Aim/Objectives 
The aim of the work is to compare the results of the functional outcome, 
mechanical outcome and the possible complications of bipolar 
hemiarthroplasty versus dual mobility cups total hip replacement in fracture 
neck of femur in active elderly patients. 
 
3.Methodology 
• Type of the study: randomized control clinical trial  
• Study setting: Ain Shams University hospitals 
• Study period: 24 months 
• Study population: active elderly patients with fracture neck of femur  
Inclusion criteria: 
o Sex: both sexes  
o Age: 60-80 years old  
o Lesion: displaced fracture neck of femur  
    Exclusion criteria: 
o Acetabular grade 3 arthritis  
o Acetabular dysplasia  
o Previous hip surgeries  
• Sampling method: convenient sample 
• Sample size: 30 patients will be randomly divided by a computer 
generated sequence in to 2 groups: 
o Group A: will undergo bipolar hemiarthroplasty  
o Group B: will undergo dual mobility cups total hip 
replacement. 

                                                                                                                            
 
MDThesis/MFA/ISRO/FacultyofMedicine/ASU 
4 
 
• Ethical considerations: will be followed by obtaining the hospital 
research/ethics committee approval and written informed consents from 
the patients. 
• Study tools: 
o Preoperative diagnosis and evaluation: 
➢ Clinical Evaluation: 
- History: Katz index of independence in activity of daily living (ADL) 
will be used to estimate the independence of patients immediately 
before their fracture occurred. 
- General examination 
- Local examination 
 
➢ Radiological Evaluation:  
o Plain X-ray Pelvis showing both hips (antero-posterior) 
o Plain X-ray of the fractured hip showing the femur 
(antero-posterior & lateral). 
➢ Laboratory investigations: CBC & routine preoperative lab 
investigations  
o Operative technique:  
All the patients will be operated through the standard posterior 
approach, intra-osseous repair of the capsule and the lateral 
rotators will be done in all cases. 
Blood loss, the need for blood transfusion and the operative time 
will be recorded. 
o Post-operative management:  
▪ Proper antibiotic and analgesics will be given post-operative. 
▪ Prophylaxis against DVT  
▪ Post-operative x-rays will be done, plain X-ray pelvis showing 
both hips (antero-posterior view) & plain X-ray of the 
operated hip showing femur (antero-posterior view). 
o Follow up strategy: 
Patients will be reviewed after 2 weeks to check their 
wounds and for sutures removal, then the follow up will be 
every month in the first 6 months then every 3 months till 
the end of the study (2 years). The follow up will include: 

                                                                                                                            
 
MDThesis/MFA/ISRO/FacultyofMedicine/ASU 
5 
 
 
➢ Clinical and functional assessment:  
▪ Harris hip score to assess the function. 
▪ Visual analogue scale (VAS) to assess pain. 
▪ Emotional acceptance. 
▪ Walking ability and the use of walking aids. 
▪ Gait. 
 
➢ Radiological assessment: 
Plain X-ray as described before at every follow up visit. 
 
• Statistical Analysis: Statistical package for social science (SPSS 15.0.1 for 
windows; SPSS Inc., Chicago, IL, 2001).  Data will be presented as Mean 
and Standard deviation (+/-SD) for quantitative parametric data, and 
Median and Interquartile range for quantitative non parametric data. 
Frequency and percentage will be used for presenting qualitative data. 
Suitable analysis will be done according to the type of data obtained. 
P<0.05 will be considered significant. 
• Statistical package: data entry and statistical analysis of the collected 
data will be performed using a reliable software program. 
 
4.References  
1. Bhandari M, Devereaux PJ, Tornetta P, Swiontkowski MF, Berry DJ, Haidukewych G, et 
al. Operative management of displaced femoral neck fractures in elderly patients. 
An international survey. J Bone Joint Surg Am2005; 87:2122–30. 
2. Miyamoto RG, Kaplan KM, Levine BR, Egol KA, Zuckerman JD: Surgical management 
of hip fractures: an evidence-based review of the literature. I: femoral neck 
fractures. J Am Acad Orthop Surg 2008, 16:596-607. 
3. Hedbeck CJ, Enocson A, Lapidus G, Blomfeldt R, Törnkvist H, Ponzer S, et al. 
Comparison of bipolar Prosthesis with total hip arthroplasty for displaced femoral 
neck fractures: a concise four-year follow-up of a randomized trial. J Bone Joint Surg 
Am. 2011; 93(5): 445-50. 
4. Zi-Sheng A, You-Shui G, Zhi-Zhen J, Ting Y, Chang-Qing Z. Hemiarthroplasty vs primary 
total hip arthroplasty for displaced fractures of the femoral neck in the elderly: a 
meta-analysis. J Arthroplasty 2012; 27:583–90. 
 
 

                                                                                                                            
 
MDThesis/MFA/ISRO/FacultyofMedicine/ASU 
6 
 
 
 
 
5.  Burgers PTPW, Van Geene AR, Van den Bekerom MPJ, Van Lieshout EMM, BlomB, 
Aleem IS, et al. Total hip arthroplasty versus hemiarthroplasty for displaced femoral 
neck fractures in the healthy elderly: a meta-analysis and systematic review of 
randomized trials. Int Orthop 2012; 36:1549–60. 
6. Bensen AS, Jakobsen T, Krarup N. Dual mobility cup reduces dislocation and re-
operation when used to treat displaced femoral neck fractures. Int Orthop 
2014;38:1241–5 
7. Nich C, Vandenbussche E, Augereau B, Sadaka J. Do dual-mobility cups reduce the 
risk of dislocation in total hip arthroplasty for fractured neck of femur in patients 
aged older than 75 years? J Arthroplasty 2016; 31:1256–60.