| CTRI Number |
CTRI/2020/02/023593 [Registered on: 26/02/2020] Trial Registered Prospectively |
| Last Modified On: |
12/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pilot study using scaled preoperative radiographs of the normal side and accessible bony landmarks to restore the limb length of the fracture site during surgery |
|
Scientific Title of Study
|
Pilot study using novel technique for restoring the limb length in patients undergoing bipolar cemented hemiarthroplasty, using preoperative scaled radiographs of the normal side |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amir Ratna Shakya |
| Designation |
Resident, Orthopedics |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Orthopedics
Armed Forces Medical College Wanowrie, Solapur road, near race course
Pune
Pune
MAHARASHTRA
411040
India
Pune MAHARASHTRA 411040 India |
| Phone |
8484880211 |
| Fax |
|
| Email |
anmishakya@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ajay Deep Sud |
| Designation |
Head of Department of Orthopedics |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Orthopedics
Armed Forces Medical College Wanowrie, Solapur road, near race course
Pune
Pune
MAHARASHTRA
411040
India
Pune MAHARASHTRA 411040 India |
| Phone |
9167587625 |
| Fax |
|
| Email |
adsud123@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Amir Ratna Shakya |
| Designation |
Resident, Orthopedics |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Orthopedics
Armed Forces Medical College Wanowrie, Solapur road, near race course
Pune
Pune
MAHARASHTRA
411040
India
Pune MAHARASHTRA 411040 India |
| Phone |
8484880211 |
| Fax |
|
| Email |
anmishakya@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Force Medical College (AFMC) |
|
|
Primary Sponsor
|
| Name |
Amir Ratna Shakya |
| Address |
Department of Orthopedics
Armed Forces Medical College Wanowrie, Solapur road, near race course Pune |
| Type of Sponsor |
Other [AFMC] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amir Ratna Shakya |
Armed Forces Medical College |
Department of Orthopedics, Wanowrie Pune MAHARASHTRA |
8484880211
anmishakya@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patient with fracture of proximal femur undergoing hemi-replacement arthroplasty as the management |
|
| ExclusionCriteria |
| Details |
Patient being managed with other surgical options like THR
Patient with an operated or affected contralateral hip
Patient unfit for surgery |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Achieve equal leg length in patients of fracture of proximal femur undergoing Hemi-Replacement Arthroplasty by using Scaled Pre-operative radiographs |
Post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study and analyze the post-operative functional status. |
01 and 03 months functional assessment using Harris hip Score (HHS) |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Fracture around proximal femur are a commonly
encountered fracture in the older population with a globally increasing
incidence. The incidence of the fracture around proximal femur also rises
with age. Among the fractures of
proximal femur the incidence of intertrochanteric fracture is around 55 % fracture
neck of femur is around 32%.
Fractures around the hip are associated with
increased mortality rate, incidence being around 8-11% at the end of 30 days
and 20-30% at the end of 01 year. A delay in surgery is due to various
factors such as associated
co-morbidities requiring pre-operative optimization in these group of patients and subsequent
surgery readiness and resource availability factors such as high volume of
cases.
In order to achieve the goals of fracture
management the options are primarily surgical with options including reduction
and internal fixation or arthroplasty. Arthroplasty can be either Hemi-replacement
Arthroplasty (HRA) or Total Hip Arthroplasty (THA). HRA in current practice is
of two types: unipolar and bipolar. HRA is generally indicated in older
patients with a aim to regain early mobilization and better functional results.
HRA prevents the bed ridden state and thus avoids the complications associated
with recumbency.
In order to achieve better functional results
following HRA the hip biomechanics need to be restored to its native state. The
femoral offsets and limb length are the factors that decide the biomechanics of
the operated hip. Inability to restore the leg length has shown to be
associated with back pain, gait abnormalities, dislocation,
prosthesis loosening and poor functional capacity.
Incidence of limb length discrepancy following
a HRA with a unipolar prosthesis is as high as 50% when the difference is
minimum 10 mm. whereas in bipolar Arthroplasty the incidence decreases but
is more when compared to THA
There are various means of reducing the
incidence of LLD described in literature in patients undergoing Total Hip
Arthroplasty. These methods were broadly classified by Khanduja et al into 03 groups a) those which rely on preoperative templating and determination
of the osteotomy site with intra-operative determination of the osteotomy site
in relation to the lesser trochanter; b) those using intra-operative pelvic and
femoral markers for reference and; c) experimental methods which employ complex
mathematical calculations and ultrasound probes to measure leg lengths
accurately.
However there is limited available literature
on methods of reduction of limb length discrepancy in patients of proximal
femur fracture undergoing Hemi-replacement Arthroplasty. Methods used are
taking reference of the greater trochanter in relation to head of femur on
normal side and pre-operative templating and estimating the size of prosthesis
This study will be undertaken at a tertiary
care center in western part of India in patients of fracture of proximal femur
undergoing Hemi-replacement Arthroplasty and wherein Pre-operative Scaled
Radiograph shall be taken and a novel technique using fixed accessible
landmarks will be used to assess the level of cuts intraoperatively with a aim
to achieve equal limb length or minimize limb- length discrepancy. |