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.: PACTR201811610843236 Date of Approval: 21/11/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Plate augmentation for treatment of tibial or femoral nonunion after intramedullary nailing
Official scientific title Plate augmentation for treatment of tibial or femoral nonunion after intramedullary nailing with and without bone graft.
Brief summary describing the background and objectives of the trial Background Plate augmentation for treatment of tibial or femoral nonunion after intramedullary nailing is a successful method. The indication for using concomitant bone graft is not clear and controversial. The purpose of this work was to compare the results of using this technique with and without bone graft. Materials and Methods A prospective study on 53 patients with non-union of femoral or tibial shaft fractures after intramedullary nailing were treated with plate augmentation leaving the nail in situ. 27 patients had the plate augmentation and bone grafting (group I), and the other 26 patients had the plate augmentation without bone grafting (group II). The two groups were matched as regards characteristics of patients and fractures. All patients were followed up clinically and radiologically till union occurred. Operative time and blood loss had been recorded. Results Bony union was achieved in all patients of group I in 5.4 months (range: 3–7). In group II, nonunion persisted in 4 out of 26 patients; and all these cases were comminuted fractures with oligotrophic nonunion. Average operative time was 76.3 minutes in group I, while in group II it was 56.1. The average blood loss was 237 ml and 188ml in group I and II respectively. Conclusion Bone graft is recommended only in comminuted fractures with oligotrophic nonunion. This is applied if we use strict operative technique including refreshment of the fracture ends, compression at the fracture site, achieving contact of at least 50% between fracture ends, and confirming rotational stability intra-operatively.
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,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/03/2009
Actual trial start date 01/03/2009
Anticipated date of last follow up 31/01/2017
Actual Last follow-up date 22/11/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 53
Recruitment status Completed
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group I with bone graft 12 - 36 months Patients with femoral nonunion were operated in lateral position. The nonunion site was exposed though a posterolateral approach, and 4.5 mm AO broad dynamic compression plate was applied to the lateral aspect of the femur. Tibial non unions were exposed through an incision one cm lateral to tibial crest with the patient in the supine position. A narrow 4.5 mm AO dynamic compression plate was applied to the lateral aspect of the tibia. After exploration of the fracture site, soft tissue interposition was removed, fracture ends were refreshed, then compressed, and stabilized by the plate. Applying these steps, a maximum contact (at least 50%) between the two fracture ends was tried to be achieved in all cases. Two or three bicortical screws proximal and distal to fracture site were applied. Excessive devascularisation of the bone or the soft tissue envelope was avoided. In cases of group I, autogenous cancellous bone grafts were obtained from iliac crest, and placed around the fracture. In all cases, there was visible motion at the fracture site before plate fixation, but this movement disappeared after plate augmentation. The volume of blood loss and the operative time were recorded for all operations. All patients received IV antibiotics (ceftriaxone 1 gram) two hours pre-operatively and every 12 hours post-operatively for two days. As a prophylaxis of thrombo-embolism, low molecular weight heparin (enoxaparin 40 mg once a day) was administered subcutaneously on the first post-operative day, and continued for 15 days post-operatively. Patients were allowed range of knee motion exercise and partial weight bearing with the aid of crutches immediately after surgery. Full weight-bearing was allowed when radiographic union occurred. 27
Control Group Group II without bone graft 12 - 36 months Patients with femoral nonunion were operated in lateral position. The nonunion site was exposed though a posterolateral approach, and 4.5 mm AO broad dynamic compression plate was applied to the lateral aspect of the femur. Tibial non unions were exposed through an incision one cm lateral to tibial crest with the patient in the supine position. A narrow 4.5 mm AO dynamic compression plate was applied to the lateral aspect of the tibia. After exploration of the fracture site, soft tissue interposition was removed, fracture ends were refreshed, then compressed, and stabilized by the plate. Applying these steps, a maximum contact (at least 50%) between the two fracture ends was tried to be achieved in all cases. Two or three bicortical screws proximal and distal to fracture site were applied. Excessive devascularisation of the bone or the soft tissue envelope was avoided. In cases of group I, autogenous cancellous bone grafts were obtained from iliac crest, and placed around the fracture. In all cases, there was visible motion at the fracture site before plate fixation, but this movement disappeared after plate augmentation. The volume of blood loss and the operative time were recorded for all operations. All patients received IV antibiotics (ceftriaxone 1 gram) two hours pre-operatively and every 12 hours post-operatively for two days. As a prophylaxis of thrombo-embolism, low molecular weight heparin (enoxaparin 40 mg once a day) was administered subcutaneously on the first post-operative day, and continued for 15 days post-operatively. Patients were allowed range of knee motion exercise and partial weight bearing with the aid of crutches immediately after surgery. Full weight-bearing was allowed when radiographic union occurred 26 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria in the two groups were adult patient with aseptic non-union of femoral or tibial shaft fracture after intramedullary nailing. Septic non-union children recent fractures Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 58 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 01/01/2009 Institutional Review Board Faculty of Medicine Menoufia University
Ethics Committee Address
Street address City Postal code Country
2 , Yasen Abdelghafar Street Shbin Elkom Menoufia 024800 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical and radiographic bony union 3 - 36 months
Secondary Outcome The range of hip and knee motion 3 - 36 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University Hospitals 2 , Yasen Abdelghafar Street shbin Elkom Menoufia 024800 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Elsayed Morsi 58 port saeed street camp shizar Alexandria 022111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 2 , Yasen Abdelghafar Street Shbin Elkom Menoufia 024800 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elsayed Morsi dr.elsayedmorsi@gmail.com +201227469041 58, Port Saeed Street, Camp chizar
City Postal code Country Position/Affiliation
Alexandria 022111 Egypt Professor of Orthopedic Surgery Faculty of Medicine Menoufia University
Role Name Email Phone Street address
Public Enquiries Mahmod Hadhod mahmodhadhod@yahoo.com +201011289395 2 , Yasen Abdelghafar Street
City Postal code Country Position/Affiliation
Menoufia 024800 Egypt Professor of orthopedic surgery Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Elsayed Morsi dr.elsayedmorsi@gmail.com +201227469041 58, Port Saeed Street, Camp Chizar
City Postal code Country Position/Affiliation
Alexandria 022111 Egypt Professor of orthopedic surgery Faculty of medicine Menoufia University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Results showed that bony union was achieved in all patients of group I in 5.4 months (range: 3–7). In group II, nonunion persisted in 4 out of 26 patients; and all these cases were comminuted fractures with oligotrophic nonunion. Average operative time was 76.3 minutes in group I, while in group II it was 56.1. The average blood loss was 237 ml and 188ml in group I and II respectively. 20/11/2018 20/11/2018
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks www.pactr.org
Changes to trial information