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CTRI Number  CTRI/2024/10/075119 [Registered on: 11/10/2024] Trial Registered Prospectively
Last Modified On: 10/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Preoperative Factors, Surgical Approach, Treatment Protocol for Improved Surgical Outcomes after Open Elbow Release Surgery in Posttraumatic Stiffness of Elbow 
Scientific Title of Study   The role of preoperative factors, surgical approach, preoperative and postoperative mobilisation for improved surgical outcomes after open elbow arthrolysis in posttraumatic elbow stiffness 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anil K Bhat 
Designation  Professor and Head of Department 
Affiliation  Kasturba Medical College Manipal, MAHE 
Address  Department of Hand Surgery, Kasturba Medical College Manipal, MAHE Udupi

Udupi
KARNATAKA
576104
India 
Phone  9008419336  
Fax    
Email  anil.bhat@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. Anil K Bhat 
Designation  Professor and Head of Department 
Affiliation  Kasturba Medical College Manipal, MAHE 
Address  Department of Hand Surgery, Kasturba Medical College Manipal, MAHE Udupi

Udupi
KARNATAKA
576104
India 
Phone  9008419336  
Fax    
Email  anil.bhat@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Nikku Mathew Geevarughese 
Designation  MCh Registrar 
Affiliation  Kasturba Medical College Manipal, MAHE 
Address  Department of Hand Surgery, Kasturba Medical College Manipal, MAHE Udupi


KARNATAKA
576104
India 
Phone  9632599776  
Fax    
Email  drnikkumathew@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College Manipal, MAHE, Karnataka 576104 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal, MAHE  
Address  Kasturba Medical College Manipal, MAHE Udupi Karnataka 576104 
Type of Sponsor  Research institution and hospital 
 
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 Nikku Mathew  Kasturba Medical College Manipal  OPD Room no: 5, Department of Hand Surgery, Ground floor, Smt. Sharada Pai OPD Block, Kasturba Medical College Manipal, MAHE Udupi Karnataka 576104
Udupi
KARNATAKA 		 9632599776

drnikkumathew@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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M246||Ankylosis of joint, (2) ICD-10 Condition: M245||Contracture of joint, (3) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients of posttraumatic elbow stiffness who had failed trials of a structured post-injury or preoperative therapy program aided with splinting for at least three to six months, had elbow arc of motion of less than 100 degree, flexion less than 105 degree, or extension less than 40 degree at the end of the therapy program and had a minimum of 12 months postoperative followup 
 
ExclusionCriteria 
Details  Patients with moderate stiffness downgraded with post-injury therapy, as well as those with ipsilateral brachial plexus injury and other ipsilateral arm and forearm injuries 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To determine the functional outcome following open elbow arthrolysis  At minimum of 12 months after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To outline the post-injury or pre- and postoperative mobilization protocol implemented  After therapy protocol 
To describe the role of the medial approach  At minimum of 12 months after surgery 
To identify various preoperative factors contributing towards favorable functional outcomes in post-traumatic elbow stiffness treated by open elbow arthrosis  At minimum of 12 months after surgery 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   21/10/2024 
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="0"
Months="3"
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 - 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
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 20-01-2025 and end date provided 20-01-2026?
    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  

An observational ambispective cohort study will conducted in a tertiary care center in south India. Patients who underwent elbow arthrolysis for post-traumatic elbow stiffness between 2013 and 2023 will be retrospectively identified and invited to participate. Once the study population is defined, the cohort of patients will be prospectively followed up at the clinic to assess pain, neurological status, stability, range of movements, and functional and radiological outcomes. Patients presenting with posttraumatic stiffness were placed in a structured preoperative therapy program and splinting. Those persisting with moderate to severe types of stiffness three to six months following the therapy program underwent open elbow arthrolysis. The advantages of the medial approach will be identified. 

Study hypotheses: Elbow stiffness in patients undergoing the therapy protocol improves and downgrades their stages of stiffness. Functional outcomes improve in patients undergoing open elbow arthrolysis. The medial approach for elbow arthrolysis will show better outcomes. Several preoperative factors like time from injury, severity of stiffness, extrinsic type of stiffness, absence of preoperative heterotopic ossification, and arthritic changes show improved outcomes and can be identified as prognostic factors.

 
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