| CTRI Number |
CTRI/2024/07/070600 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
14/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess sensory loss around knee after total knee replacement surgery |
|
Scientific Title of Study
|
Prospective cohort study for assessment of cutaneous hypoesthesia around knee replacement surgery |
| 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 Jitendra Wadhwani |
| Designation |
Associate Professor |
| Affiliation |
Pt B D S PGIMS, Rohtak |
| Address |
Pt B D S PGIMS, Rohtak, Haryana, India. PIN:124001
Room no 29, Chaudhary Ranbir Singh OPD, Block B, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9812337494 |
| Fax |
|
| Email |
drjitendra28.03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitendra Wadhwani |
| Designation |
Associate Professor |
| Affiliation |
Pt B D S PGIMS, Rohtak |
| Address |
Pt B D S PGIMS, Rohtak, Haryana, India. PIN:124001
Room no 29, Chaudhary Ranbir Singh OPD, Block B, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9812337494 |
| Fax |
|
| Email |
drjitendra28.03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sourabh |
| Designation |
Junior resident |
| Affiliation |
Pt B D S PGIMS, Rohtak |
| Address |
Department of Orthopaedics, Pt B D S PGIMS Rohtak, Haryana, India. PIN 124001
Rohtak
HARYANA
124001
India |
| Phone |
7988617038 |
| Fax |
|
| Email |
sourabhm0000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college
[Pt B D S PGIMS, Rohtak, Haryana, India. PIN: 124001] |
|
|
Primary Sponsor
|
| Name |
Pt. B.D Sharma PGIMS Rohtak |
| Address |
Department of Orthopaedics, Pt B D S PGIMS, Rohtak, Haryana, India. 124001 |
| 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 Sourabh |
Pt. B.D Sharma PGIMS Rohtak |
Chaudhary Ranbir Singh OPD, Block B, Department of Orthopaedics
Rohtak
HARYANA |
7988617038
sourabhm0000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, Pt. B. D. Sharma PGIMS/UHS, Rohtak |
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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with primary osteoarthritis of the knee who will undergo primary Total knee replacement surgery during the study period will be included |
|
| ExclusionCriteria |
| Details |
Previous knee surgery or having a knee scar, Patients having impaired sensation of the knee from any cause, before Total knee replacement e.g. spinal stenosis, recent spine surgery, peripheral neuropathy, peripheral vascular disease etc, Secondary Osteoarthritis of knee, Patients with a valgus deformity around knee, Severe Varus deformity (more than 20 degree) around knee, Inflammatory arthritis of knee, Revision Total knee replacement patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Calculate the incidence of cutaneous hypoesthesia around knee after primary knee
replacement surgery |
At two weeks, one month, two months and three months minimum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate association of various risk factors with cutaneous hypoesthesia |
At two weeks, one month, two months & three months minimum |
| correlation of PROMs (Patient reported outcome measures) {Forgotten Joint Score}[ FJS 12] with cutaneous hypoesthesia |
minimum three months after surgery or later |
| Evaluate early functional outcomes after primary total knee arthroplasty |
minimum three months after surgery or later |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
27/07/2024 |
| 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="1"
Months="4"
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 - NO
|
|
Brief Summary
|
All surgeries will be performed by using conventional TKA surgical technique including a midline skin incision and the medial parapatellar approach under regional/general anaesthesia. The length of the skin incision used will be according to exposure needed. The first assessment will be done at two weeks post operatively after stitch removal. All the demographic details, medical history, implant information (type of knee prosthesis, patella resurfacing, use of intramedullary stem etc.), surgical details (tourniquet time, length of scar, type of anaesthesia, intraoperative complication if any etc.), sensory assessment around knee will be recorded at this point. Postoperative complications (wound-healing problems, such as dehiscence, drainage, or necrosis, and venous thrombosis etc.) will be noted. The patients will be further followed up at 1 month, 2 months and 3 months. For the purpose of sensory assessment, the locations of numbness will be grouped into 4 zones with patella being the center: Zone I: Superomedial quadrant Zone II: Superolateral quadrant 14 Zone III: Inferolateral quadrant Zone IV: Inferomedial quadrant sensory assessment will be done using the blunt pin-prick sensation test which is a simple and reliable method to assess numbness. A blunt pin-prick will be performed every 1 cm vertically and horizontally center being midpoint of patella. Margins and locations of skin numbness will be recorded. An area of skin numbness is defined as an area of at least 1 cm2 . Loss of protective sensations will be assessed by a Semmes-Weinstein monofilament size 5.07/10g, which will be applied to the skin with the knee in full extension. The patients will be asked to map out the area of hypoesthesia around knee with skin marker pen. After marking up of the area by the patient a calibrated digital picture of the area marked with knee joint will be taken. Area of hypoesthesia will be calculated by using calibrated picture of the knee in full extension using Image J software18 (US, National Institutes of Health, Bethesda, MD). The FJS-12 (Forgotten joint score) Questionnaire will be filled by asking specific questions from the patients and scores obtained will be used for analysis of the same and its correlation with cutaneous hypoesthesia at final follow up with minimum follow up of 3 months. |