| CTRI Number |
CTRI/2024/02/062250 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
02/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of functional outcome of distal end radius fractures managed with external fixation methods |
|
Scientific Title of Study
|
Evaluation of functional outcome of distal end radius fractures managed with external fixation methods: A cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Patel Nipun |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College |
| Address |
Department of Orthopaedics
Rohilkhand Medical College and Hospital Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
8460863830 |
| Fax |
|
| Email |
patelnipun7777@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Lekhraj Verma |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College |
| Address |
Department of Orthopaedics
Rohilkhand Medical College and Hospital Bareilly UP
Bareilly UTTAR PRADESH 243006 India |
| Phone |
9418077080 |
| Fax |
|
| Email |
vermalekhraj@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Praveen Garg |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College |
| Address |
Department of Orthopaedics
Rohilkhand Medical College and Hospital Bareilly UP
Bareilly UTTAR PRADESH 243006 India |
| Phone |
8979225655 |
| Fax |
|
| Email |
drpraveengarg.ortho@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of orthopedics
Rohilkhand medical college and hospital
Bareilly
|
|
|
Primary Sponsor
|
| Name |
Rohilkhand medical college |
| Address |
department of orthopaedics
rohilkhand medical college and hospital bareilly up |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Lekhraj Verma |
Rohilkhand Medical College |
Department of Orthopaedics
OT Complex
Rohilkhand Medical College and Hospital
Bareilly Bareilly UTTAR PRADESH |
9418077080
vermalekhraj@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,RMCH,Bareilly, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S525||Fracture of lower end of radius, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years
AO classification type A (extraarticular fracture), type B ( partial intra-articular ), and type C ( complete intraarticular )
Closed as well as open fractures
Those who ready to give informed written consent
|
|
| ExclusionCriteria |
| Details |
Pathology of wrist joint or malunited distal radius fracture
Those who will be maked unfit for the procedure after pre- anaesthetic check up
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the functional outcome of distal end radius fractures managed with external fixation.
|
1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the radiological outcome of distal end radius fractures managed with external fixation. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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)
|
12/02/2024 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Fractures
of distal end radius are most common fractures of upper limb, consisting more
than 17.5% of all fractures. Distal radial fractures have a bimodal type of age
distribution both in younger and elderly population. Women aged 60
and older are most likely to suffer from fractures of distal radius.
A
lower amount of strong cortical bone and higher amount of weaker cancellous
bone are main reasons for the metaphyseal widening of the distal radius and
predisposed it to fractures. The major risk factors are osteoporosis and a
tendency to fall. Therefore, a fracture of the distal radius is typically the
result of a fall on the outstretched arm in a post menopausal woman.
Until
about 60 years ago, it was general conception that most distal radial fractures
could be treated conservatively. Only recently, it was clinically proved that
surgical correction of intra-articular step-off and radial shortening had
improved patient outcome. These issues are not for elderly people
who have low functional and physical demand. In general anatomic reduction
should be followed in younger and high-demand elderly patients to initiate
early mobilization with extra-articular or intra-articular fractures. Surgical
management may also required for low-demand elders with severely displaced
intraarticular fracture or median nerve compression but the prime focus for
these patients should be on joint movement.
Plating, intramedullary fixation, external fixation
or pinning are commonly used for irreducible extra-articular fractures, intra
articular fractures and for demanding patients who require early mobilization. Close reduction and cast immobilization which are the principal mode of
management of distal radius fractures but it may lead to fracture malunion and
subluxation /dislocation of distal radio ulnar joint, resulting in poor
outcomefunctionally, radiographic and cosmetically results. The
residual worse deformity of wrist adversely affected wrist motion and hand
function, thereby interfering with the mechanical advantage of extrinsic hand
musculature. It also cause pain, limitation of forearm motion, and
decreased grip strength as a result of arthrosis of the radiocarpal and distal
radioulnar joints.
The
external fixator used commonly in the treatment of distal radius fractures and
also for various injuries about the wrist. The addition of K-wires to an external
fixation has been proven to have increased rigidity. Comminuted fracture
patterns often difficult to reduce and maintain the reduction over time. So,
additional K-wires are providing additional stability to the fracture site.
Now,
the trend is towards open reduction and internal fixation (ORIF) and away from
external fixation. However, we believe that, external fixation is
a valuable tool for treatment of fracture and through this review we will show
its effectiveness.
Our
study deals with the radiological assessment of the post-operative fixation of
the fractures, done using X-rays. Standard anteroposterior and lateral views
taken to assess fracture pattern and to assess the parameters like palmar tilt,
radial height, radial inclination, displacement and involvement of radio carpal
and distal radio-ulnar joints. |