| 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
|
|
|
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
|
|
|
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. |