Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201412000946361 Date of Approval: 25/11/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Lateral versus Modified Tilted Supine Position of the Patients Undergoing Peritrochanteric Fracture Fixation by a Dynamic Hip Screw
Official scientific title A Radiological Study Comparing Lateral versus Modified Tilted Supine Position of the Patients Undergoing Peritrochanteric Fracture Fixation by a Dynamic Hip Screw: A Randomized Controlled Clinical trial
Brief summary describing the background and objectives of the trial Proper orthopedic patient positioning on the operating table is essential for a smooth surgery, allowing easy access to the injured extremity for good fluoroscopic imaging quality. Complications rate due to patient positioning should be minimal. Fracture tables with a capacity for skeletal traction are widely used in orthopedic surgical procedures. The most widely used position for hip fractures is the supine position. For peritrochanteric fractures, the modified tilted supine position usually obtains good alignment. Under the guidance of C-arm imaging on anteroposterior and lateral views, reduction of the fracture site can further be adjusted by abduction/adduction and internal rotation/external rotation. However, this position has some procedural limitations and can results in serious complications such as skin necrosis, nerve palsy, compartment syndrome, and iatrogenic fracture. Additionally, some surgeons were unable to obtain a good lateral view image. In some obese patients the image intensifier can be obstructed by the nonsurgical leg. This position also may cause inappropriate positioning of a screw or nail in the femoral head, leading to fixation failure in trochanteric fractures. The lateral position is recently used for surgical approach for many orthopedic patients. One of the advantages to this position is the familiarity of the anatomy for most hip surgeons. In obese patients, the lateral position provides improved maneuverability, as the subcutaneous abdominal and buttock fat falls away making entry easier. There is also less risk to the neurovascular structures. Furthermore, this position helps more in the fracture reduction, especially the sagging of the distal fragment. Therefore, we, hereby, aim in this study to compare prospectively between the lateral and the modified tilted supine position in patients undergoing peritrochanteric fracture fixation using dynamic hip screw regarding the procedural difficulties and the radiological outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Peritrochanteric fracture,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/12/2014
Actual trial start date
Anticipated date of last follow up 31/12/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Each participant will be randomly assigned following simple randomization procedure by using closed white envelops: 36 envelops assign the group to be followed. Those envelops include 18 paper charts (Fig. A) and 18 paper charts (Fig. B), which are folded three times not to show its contents to assure random assignment. WITH Supine position Figure A: Paper inside the closed white envelopes. WITH Lateral position Figure B: Paper inside the closed white envelopes. Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lateral position on fracture table once Adequate padding will be done. A fracture table with a lateral hip distractor will be used. The hip is positioned in slight abduction, flexion, and external rotation. Axial traction is then applied. The foot is neutral or slightly externally rotated. 18
Control Group Modified tilted supine position once The patient¿s feet are secured in the footboots of two traction units. A silicon pad will be placed under the affected hip to tilt the pelvis approximately 15° to the opposite side. The ipsilateral arm must be brought across the patients¿ body. raction is then applied to the affected leg at 10° upward. The nonsurgical leg is relaxed and kept low to minimize obstruction of the C-arm tubes. 18 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Male and female patients - Age over 40 years - Stable or unstable peritrochanteric fractures as a result of either high or low energy trauma - No medical contraindications to surgery - Patients are keen to provide informed consent - Patients with previous hip surgeries - Pathological fractures - Osteoarthritic hip changes - Non-united fractures 40 Year(s) 95 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/11/2014 High Research Ethics Committee, Faculty of Medicine, Suez Canal University
Ethics Committee Address
Street address City Postal code Country
4.5 Km Ring road Ismailia 41111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Procedural dificulties: The time taken to position the patient, and to reduce the fracture (setting-up time), Operating time, mean Image Intensifier exposure time, perioperative blood loss, postoperative wound drainage, and the amount of blood transfused. Intraoperative
Secondary Outcome Radiological outcomes: amount of displacement between the two main fracture fragments, the neck-shaft angle, the position of the implant, Tip Apex Distance and the modified Parker¿s Index Ratio. Immediate postoperative 6 weeks postoperative 3 months postoperative 6 months postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University Hospitals, Orthopedic surgery and Trauma department 4.5 Km Ring Road Ismailia 41111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Governmental health insurance Ring Road, 5th Stage, El-Sheikh Zayed District Ismailia 41112 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Asser Sallam, MD, PhD 4.5 Km Ring Road, Suez canal University Hospitals, Department of Orthopedic surgery and Trauma Ismailia 41111 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Imam, MD, PhD 4.5 Km Ring Road, Suez canal University Hospitals, Department of Orthopedic surgery and Trauma Ismailia 41111 Egypt
Mohamed Ghareeb, MSc 4.5 Km Ring Road, Suez canal University Hospitals, Department of Orthopedic surgery and Trauma Ismailia 41111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asser Sallam assersallam@hotmail.com +201095277212 4.5 Km Ring Road, Suez Canal University Hospitals, Department of Orthopedic Surgery and Trauma
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Lecturer and consultant of Orthopedic surgery and Trauma
Role Name Email Phone Street address
Public Enquiries Mohamed Ghareeb mmohamedaly@hotmail.com +201004074534 4.5 Km Ring Road, Suez Canal University Hospitals, Department of Orthopedic Surgery and Trauma
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Assistant lecturer and specialist of Orthopedic surgery and Trauma
Role Name Email Phone Street address
Scientific Enquiries Mohamed Imam mohdn@hotmail.com +201110000834 4.5 Km Ring Road, Suez Canal University Hospitals, Department of Orthopedic Surgery and Trauma
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Lecturer and consultant of Orthopedic surgery and Trauma
REPORTING
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