| CTRI Number |
CTRI/2022/11/047464 [Registered on: 21/11/2022] Trial Registered Prospectively |
| Last Modified On: |
18/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
Activity limitation and participation restriction in patients treated with nail cement spacer sugery for shoulder |
|
Scientific Title of Study
|
Activity limitation and participation restriction in patients treated with proximal humerus nail cement spacer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjusha Vagal |
| Designation |
Officer in charge Occupational Therapy department, Tata memorial hospital |
| Affiliation |
Tata memorial hospital, parel |
| Address |
TATA MEMORIAL HOSPITAL. Dr. E Borges Road, Parel, Mumbai - 400 012
TATA MEMORIAL HOSPITAL. Dr. E Borges Road, Parel, Mumbai - 400 012
Mumbai
MAHARASHTRA
400 012
India |
| Phone |
9867552266 |
| Fax |
|
| Email |
vagalmanjusha@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjusha Vagal |
| Designation |
Officer in charge Occupational Therapy department, Tata memorial hospital |
| Affiliation |
Tata memorial hospital, parel |
| Address |
TATA MEMORIAL HOSPITAL. Dr. E Borges Road, Parel, Mumbai - 400 012
TATA MEMORIAL HOSPITAL. Dr. E Borges Road, Parel, Mumbai - 400 012
Mumbai
MAHARASHTRA
400 012
India |
| Phone |
9867552266 |
| Fax |
|
| Email |
vagalmanjusha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjusha Vagal |
| Designation |
Officer in charge Occupational Therapy department, Tata memorial hospital |
| Affiliation |
Tata memorial hospital, parel |
| Address |
TATA MEMORIAL HOSPITAL. Dr. E Borges Road, Parel, Mumbai - 400 012
TATA MEMORIAL HOSPITAL. Dr. E Borges Road, Parel, Mumbai - 400 012
Mumbai
MAHARASHTRA
400 012
India |
| Phone |
9867552266 |
| Fax |
|
| Email |
vagalmanjusha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai-12 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Road, Parel, 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 Kajal Rajpurohit |
Tata memorial hospital |
Occupational therapy department main building ground floor OPD 94
Mumbai
MAHARASHTRA |
9004409903
krr8111998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata memorial hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M258||Other specified joint disorders, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1. Patients treated for primary tumors of proximal humerus with wide
resection and reconstruction using nail cement spacer with curative intent.
2. Patients treated before November 2020 for primary tumors of proximal
humerus nail cement spacer.
3. Age group: >18 years
4. Patients who are able to read, write and communicate in English or Hindi
language. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1. Local recurrence /metastasis at the operated site within past 2 years or at
the time of evaluation.
2. Current infection at operated site.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objective:
1. To measure Occupational Performance of patients treated with nail cement
spacer for primary tumours of proximal humerus using Canadian
Occupational Performance Measure (COPM)
|
one time assessment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary objective:
2. To measure Performance Components using standard Occupational
Therapy Assessment proforma of patients treated with nail cement spacer
for primary tumours of proximal humerus.
3. To measure Emotional Outcomes of patients treated with nail cement
spacer for primary tumours of proximal humerus using Depression,
Anxiety and Stress Scale -21 items (DASS-21).
4. To measure Functional Outcomes of patients treated with nail cement
spacer for primary tumours of proximal humerus using Toronto Extremity
Salvage Score (TESS). |
one time assessment |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
24/11/2022 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Lay Summary This study will find the activity limitation and participation restriction experienced by patients following 18 months of Nail Cement Spacer Reconstruction. The long-term aim being designing and implying appropriate rehab for them. Patients will be screened through the medical records for the inclusion exclusion criteria and will be consented for the study. Patients above 18 years of age, treated with nail cement spacer for primary proximal humerus tumor before November 2020 will be assessed one time, on OPD basis in Occupational Therapy department at Tata Memorial Hospital. The study period will be 6-8 months after IEC approval. |