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.: PACTR201607001612293 Date of Approval: 02/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Lateral column lengthening versus medial displacement calcaneal osteotomy in stage II tibialis posterior tendon dysfunction
Official scientific title Lateral column lengthening versus medial displacement calcaneal osteotomy in stage II tibialis posterior tendon dysfunction
Brief summary describing the background and objectives of the trial To compare lateral column lengthening versus medial calcaneal displacement osteotomy clinically and radiologically in patients suffering from tibialis posterior tendon insufficiency stage II. The purpose of this investigation was to compare the changes in six radiographic parameters of pedal station over time in a series of patients who had reconstruction with either one of the two procedures. The subtalar and talonaviuclar joints will be assessed and graded for the presence of osteoarthritis before and after reconstruction to identify radiographic evidence of hindfoot degeneration. This study also compared rates of complications and reoperations rate for each procedure. The results of these comparisons may reveal differences in the capacity of these two procedures to realign a flexible flatfoot, to preserve the initial correction achieved by the reconstruction, and to avoid postoperative complications and the need for subsequent surgery. Method of randomization by concealed envelop technique
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied pes plannus,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/09/2015
Actual trial start date 14/09/2015
Anticipated date of last follow up 02/01/2017
Actual Last follow-up date 02/01/2017
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Not yet recruiting
Publication URL Lateral column lengthening versus medial displacement calcaneal osteotomy in stage II tibialis posterior tendon dysfunction
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Method of randomization by concealed envelop technique all data will be given to the statistical man by a resident doctor not participating in the research Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group lateral column lengthening its a surgical procedure inapplicable A traditional method described by Evans (or the modification described by Hintermann) is osteotomy through the anterior portion of the calcaneus, exploration of the interval between the intermediate and anterior facets of the calcaneus, and preservation of the calcaneocuboid joint. The amount of distraction necessary to correct the flatfoot was determined by visual inspection of the position of th 20 Uncontrolled
Experimental Group medial displacement calcaneal osteotomy its a surgical procedure inapplicable The medial displacement calcaneal osteotomy will be performed as originally described by Gleich and subsequently modified by others.The osteotomized tuberosity will be translated medially 1 cm and fixed with two partially-threaded cancellous lag screws directed parallel to the longitudinal axis of calcaneus and perpendicular to the osteotomy. 20 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. An adult acquired flatfoot deformity, type II tibilais posterior insufficiency 2. Flexible which could be corrected to a plantigrade posture with manual manipulation 3. Nonoperative management failed in all patients in this series 4. No joint arthritis 1- Recurrent cases after previous surgery 2- Foot infection 3- Joint arthritis 4- Joint hyper mobility 18 Year(s) 60 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 10/04/2016 ethics committee of faculty of medicine ,assiut university
Ethics Committee Address
Street address City Postal code Country
faculty of medicine 5th floor , ethics committee assiut
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The purpose of this investigation was to compare the changes in six radiographic parameters of pedal station over time in a series of patients who had reconstruction with either one of the two procedures. The subtalar and talonaviuclar joints will be assessed and graded for the presence of osteoarthritis before and after reconstruction to identify radiographic evidence of hindfoot degeneration. 1-Talocalcaneal (TC) angle in anteroposterior view 2-Talonavicular coverage (TNC) in anteroposterior view 3-The talo-first metatarsal TMT in lateral view 4-Talocalcaneal TC in lateral view 5-Calcaneal pitch (CP) angles Meary's angle in lateral view. 6-Saltzman view 7-Kellgren and Lawrence scale
Secondary Outcome This study also compared rates of complications and reoperations rate for each procedure. The results of these comparisons may reveal differences in the capacity of these two procedures to realign a flexible flatfoot, to preserve the initial correction achieved by the reconstruction, and to avoid postoperative complications and the need for subsequent surgery. 1-The clinical assessment should consist of a general examination of the musculoskeletal system, in addition to the specific foot and ankle examination. 2-Visual analogue scale (VAS) 3- Foot function index 4- American orthopedic foot and ankle society's (AOFAS) scale
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
assiut university hospitals assiut university hospitals, orthopedic department assiut 71515 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
assiut university hospitals , assiut university hospitals , assiut 71515 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor orthopedic department assiut university hospitals , assiut 71515 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
orthopedic department assiut university hospitals, orthopedic department assiut 71515 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kamal Gaafary kamal.elgafari@med.au.edu.eg 0020882413345 orthopedic department , assiut university hospitals
City Postal code Country Position/Affiliation
assiut 71515 Egypt
Role Name Email Phone Street address
Public Enquiries Faisal Fahmy Adam Hajjaji adam aisal.hagagi@med.au.edu.eg 0020882413347 secretary of head of orthopedic department assiut university Egypt
City Postal code Country Position/Affiliation
assiut 71526 Egypt head of orthopedic department
Role Name Email Phone Street address
Scientific Enquiries wael el adly ahmed eladlyw@yahoo.com 00201224265850 orthopedic department , assiut university hospitals
City Postal code Country Position/Affiliation
assiut 71515 Egypt
Role Name Email Phone Street address
Scientific Enquiries hossam abu beih hossamabubeih@hotmail.com 00201002228963 orthopedic department , assiut university hospitals
City Postal code Country Position/Affiliation
assiut 71515 Egypt
REPORTING
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