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CTRI Number  CTRI/2024/10/075970 [Registered on: 28/10/2024] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Limb length discrepancy after rotationplasty surgery. 
Scientific Title of Study   Limb length discrepancy and impact on patient reported outcome measures in individuals with rotationplasty (ROTMAT). 
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 Prakash Nayak 
Designation  Professor, Sarcoma surgeon 
Affiliation  Tata Memorial Hospital, Mumbai 
Address  1221, 12th floor, Homi Bhabha Block, Tata Memorial Hospital, Dr Ernest Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  24177000  
Fax    
Email  nayakprakash@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prakash Nayak 
Designation  Professor, Sarcoma surgeon 
Affiliation  Tata Memorial Hospital, Mumbai 
Address  1221, 12th floor, Homi Bhabha Block, Tata Memorial Hospital, Dr Ernest Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  24177000  
Fax    
Email  nayakprakash@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prakash Nayak 
Designation  Professor, Sarcoma surgeon 
Affiliation  Tata Memorial Hospital, Mumbai 
Address  1221, 12th floor, Homi Bhabha Block, Tata Memorial Hospital, Dr Ernest Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  24177000  
Fax    
Email  nayakprakash@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr. E Borges road, Parel, Mumbai-400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  1221, Homi Bhabha Block, Tata Memorial Centre, Mumbai 400012  
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 Prakash Nayak  Tata Memorial Hospital, Mumbai  Room No. 93, Ground floor, Main Building, Tata Memorial Hospital, Dr Ernest Borges Marg, Parel, Mumbai-400012
Mumbai
MAHARASHTRA 
24177000

nayakprakash@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Tata Memorial Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Rotationplasty patients with at least 1 year of follow up.
2. Patients of any age and any sex shall be recruited for functional outcome and gait analyses.
3. Patients who have reached skeletal maturity (physeal fusion seen on plain X-Ray) for primary outcome measure of knee length discrepancy.
 
 
ExclusionCriteria 
Details  1. Rotationplasty patients with less than 1 year follow up.
2. Those who present with local and/or systemic relapse.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Limb length discrepancy as measured by a difference in knee heights on standard of care X- ray (radiographs).
Knee height will be measured from ASIS (anterior superior iliac spine) to the center of the talus on a scannogram taken in an upright weight bearing stance with the prosthesis in use and pelvis squared. The normal limb knee length shall be measured from ASIS to the center of the knee joint. 
Single point assessment after enrollment. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Patient or Parent reported outcome measure measured as a continuous variable using pTESS (English) / TESS(English/Marathi/Hindi).
2. Gait analyses 3D gait analysis to assess movement characteristics such as joint angular kinematics, kinetics, & spatiotemporal gait parameters using a 12-camera Qualisys® 3D Motion Capture System (Qualisys AB, Götebor, Sweden).
3. Physician reported functional outcome measure as a continuous variable (MSTS, musculoskeletal tumor society scoring system) in all patients 
Single point assessment after enrollment.  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   11/11/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
Rotationplasty is a reconstructive procedure after bone tumor removal in kids with a growing skeleton, usually below the age of 10 – 12. Removal of tumor involves removal of the part of bone that has the growth plate, which lead to that limb being ’short’ as the normal limb keeps growing. Conventional reconstruction with a prostheses that is used for adults leads to significant limb length discrepancy as the normal limb continues to grow and the leg with endoprosthesis does not. 
An expandable prosthesis, is prohibitively expensive, costs around 30 lakhs just for the prosthesis, not counting the need for future revisions. 
Rotationplasty is a single procedure, where the operated knee is kept longer than the ‘unaffected’ knee, such that they are expected to be near equal at adulthood. These predictions of limb length discrepancy are made from algorithms that predict the growth of both the operated limb and ‘unaffected’ limb. Despite best efforts, these predictions may err on either side, leaving the operated knee a little short or a little longer than the ‘normal’ knee. The effect this ‘knee’ length discrepancy has on functional outcome is not well known. 
This prospective study will measure ‘knee’ length difference in patients who have reached adulthood, where further increase in height is not expected, its effect on their function as measured by their treating doctor (physician reported functional outcome measures) and as noted by patients themselves (patient reported functional outcome measures), and gait analyses to compare outcomes with similar age patients who have had an amputation. 
Patients of Rotationplasty who have reached at least 1 year of follow up shall be seen at their usual follow up appointment. Knee difference will be measured on an X-ray. All patients shall be requested to fill test scores.
 
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