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CTRI Number  CTRI/2023/12/060928 [Registered on: 29/12/2023] Trial Registered Prospectively
Last Modified On: 05/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To study the obedience of patients in the initial period after orthopaedic lower limb surgeries, to the advices given by the treating doctor.  
Scientific Title of Study   Analysis of patients compliance and adherence to unit post-operative rehabilitation protocols during the early phase in Orthopaedic lower limb surgeries.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jonathan Abraham 
Designation  Junior Resident  
Affiliation  Kasturba Medical College, Manipal 
Address  Room no.4 Orthopaedics OPD, ground floor, OPD building, Kasturba Hospital, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9071064067  
Fax    
Email  jonathanabraham2308@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Kiran K V Acharya  
Designation  Professor and Unit Head 
Affiliation  Kasturba Medical College, Manipal 
Address  Room no.4 Orthopaedics OPD, ground floor, OPD building, Kasturba Hospital, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9343130539  
Fax    
Email  manipalortho@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jonathan Abraham 
Designation  Junior Resident  
Affiliation  Kasturba Medical College, Manipal 
Address  Room no.4 Orthopaedics OPD, ground floor, OPD building, Kasturba Hospital, Manipal, Karnataka


KARNATAKA
576104
India 
Phone  9071064067  
Fax    
Email  jonathanabraham2308@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College/ Kasturba Hospital, Manipal, Karnataka 576104 
 
Primary Sponsor  
Name  Jonathan Abraham 
Address  Room no.4, Orthopaedics OPD, Ground floor, OPD building, Kasturba Hospital, Manipal, Karnataka 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jonathan Abraham  Kasturba Hospital  Room no.4 Orthopaedics OPD, Ground floor, OPD building, Kasturba Hospital, Manipal, Karnataka 576104
Udupi
KARNATAKA 		 9071064067

jonathanabraham2308@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients who underwent Orthopaedic lower limb surgery in Kasturba hospital, Manipal who are willing to participate in the study.

Patients above the age of 18 years who underwent Orthopaedic lower limb surgery (under UNIT-2)

Patients with single injury to either lower limb without any other osseous involvement

Patients who have a follow up period after around one month, advised weight bearing and exercises, using walking aids and prescribed medication at the time of discharge.

Patients treated under the same doctor to eliminate disparity in protocols set for them


 
 
ExclusionCriteria 
Details  Patients who are not mentally/psychosocially fit to comprehend the post operative protocols instructed to them.

Patients with GCS of less than 13 on Post Op Day-1 of the lower limb surgery.

Patients accounting for any other new illness during the course of study

Patients who consulted and intervened elsewhere for the surgery performed.

Patients who went discharge against medical advise
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Multiple regression analysis will be done using the SPSS software. A p value of less than 0.05 will be considered significant. Correlation and assesment will be done to assess factors leading to variablity in compliance with rehabilitation among post operative patients.   Data collection in 6 months. Processing of data in 1 month. Analysis of data in 2 months and submission of final report in 3 months.  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the adherence and compliance of patients to UNIT rehabilitation protocols during the early phase in Orthopaedic lower limb surgeries. To assess factors leading to variability in compliance with rehabilitation among post operative patients. To subcategorise the Orthopaedic lower limb surgeries performed and compare the compliance of each one of them to the potential factors.   Data collection in 6 months. Processing of data in 1 month. Analysis of data in 2 months and submission of final report in 3 months.  
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   15/01/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jonathanabraham2308@gmail.com].

  6. For how long will this data be available start date provided 01-07-2024 and end date provided 30-06-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Patient compliance with weight bearing and physical therapy recommendations is critical following an Orthopaedic injury. Proper compliance requires knowledge of the post-operative plan and adherence to the plan. There is little published data regarding the adherence to post operative recommendations among Orthopaedic patients in lower limb surgeries. This study is to evaluate the adherence and compliance of patients to UNIT rehabilitation protocols during the early phase in Orthopaedic lower limb surgeries. To assess factors leading to variability in compliance with rehabilitation among post operative patients. To subcategorise the Orthopaedic lower limb surgeries performed and compare the compliance of each one of them to the potential factors.  
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