| CTRI Number |
CTRI/2018/12/016716 [Registered on: 18/12/2018] Trial Registered Prospectively |
| Last Modified On: |
13/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Does stature of a women have any effect on pain relief after knee replacement surgery |
|
Scientific Title of Study
|
Postoperative Pain Relief and knee injury and osteoarthritis outcome score in short vs normal stature females following knee arthroplasty surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vanita Ahuja |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department Of Anesthesia And Intensive Care, Government Medical College And Hospital, Sector 32, Chandigarh, India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaanupam@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanita Ahuja |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department Of Anesthesia And Intensive Care, Government Medical College And Hospital, Sector 32, Chandigarh, India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaanupam@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanita Ahuja |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department Of Anesthesia And Intensive Care, Government Medical College And Hospital, Sector 32, Chandigarh, India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaanupam@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College And Hospital |
| Address |
Government Medical College And Hospital,Sector 32, Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
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 Vanita Ahuja |
Government Medical College And Hospital |
Department of Anaesthesia , Block D, Level 5, Sector 32, Chandigarh
Chandigarh
CHANDIGARH |
9646121649
vanitaanupam@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Age > 40 years
2. Female gender
3. Knee arthroplasty surgery |
|
| ExclusionCriteria |
| Details |
1. Patients with revision knee arthroplasty surgery
2. Impaired cognitive functions.
3. Disabling neurological disease
4. ASA > II |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knee injury and Osteoarthritis outcome score (KOOS) |
Baseline and 6 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Height, weight, BMI and severity of knee OA preoperatively.
2. Visual analogue scale at rest and on movement
3. Number of epidural boluses and rescue analgesia
4. Waist hip ratio, degree of knee movement
|
1. Baselien
2. baseline , 12 , 24, 48 and 72 h postoperatively.
3. 12 , 24, 48 and 72 h postoperatively.
4. Baseline and 6 months follow up |
|
|
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)
|
01/01/2019 |
| 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
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
TKA is a highly efficacious and cost-effective procedure for moderate to severe knee OA. The benefits include improvement in quality of life for individuals. The patient characteristics are considered to be important determinants of who receives TKA. Lee et al found significant decrease in Visual Analog Scale (VAS) and improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at six month follow up of TKA patients, but did not report any association of gender and stature during TKA surgery follow up. So far no study has evaluated both immediate postoperative pain relief and its effect on KOOS score at six months as compared to baseline in short stature women versus normal stature women following TKA surgery. So, the present study will evaluate pain relief in postoperative period and baseline versus postoperative KOOS at six months in short versus normal stature in patients undergoing TKA surgery. |