| CTRI Number |
CTRI/2019/10/021517 [Registered on: 03/10/2019] Trial Registered Prospectively |
| Last Modified On: |
02/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
How the back pain influences the functional outcome and patient satisfaction after Total knee replacement? |
|
Scientific Title of Study
|
Influence of Total knee replacement on concomitant back pain and its correlation with functional outcome and patient satisfaction. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhanasekaran Soundarrajan |
| Designation |
Senior registrar |
| Affiliation |
Ganga medical centre and hospital |
| Address |
Research room, 5th floor, Arthroplasty unit, Department of Orthopaedics, Ganga hospital, 313, Mettupalayam road,
Coimbatore,
Tamilnadu.
Coimbatore TAMIL NADU 641043 India |
| Phone |
9994462230 |
| Fax |
|
| Email |
soundarortho@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shanmuganathan Rajasekaran |
| Designation |
Head of the department |
| Affiliation |
Ganga medical centre and hospital |
| Address |
Research room, 5th floor, Arthroplasty unit, Department of Orthopaedics, Ganga hospital, 313, Mettupalayam road,
Coimbatore,
Tamilnadu.
Coimbatore TAMIL NADU 641043 India |
| Phone |
9843022325 |
| Fax |
|
| Email |
rajasekaran.orth@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dhanasekaran Soundarrajan |
| Designation |
Senior registrar |
| Affiliation |
Ganga medical centre and hospital |
| Address |
Research room, 5th floor, Arthroplasty unit, Department of Orthopaedics, Ganga hospital, 313, Mettupalayam road,
Coimbatore,
Tamilnadu.
Coimbatore TAMIL NADU 641043 India |
| Phone |
9994462230 |
| Fax |
|
| Email |
soundarortho@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics, Ganga hospital, 313, Mettupalayam road, Coimbatore - 641043, Tamilnadu state, India |
|
|
Primary Sponsor
|
| Name |
Ganga medical centre and hospital |
| Address |
313, Mettupalayam road, Coimbatore |
| 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 |
| Dhnasekaran Soundarrajan |
Ganga medical centre and hospital |
Research room, 5th floor, Arthroplasty unit, Department of Orthopaedics, Ganga hospital, 313, Mettupalayam road, Coimbatore -641043 Coimbatore TAMIL NADU |
9994462230
soundarortho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ganga hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (2) ICD-10 Condition: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing TKR with or without LBA.
Degenerative osteoarthritis
|
|
| ExclusionCriteria |
| Details |
Previous spinal surgery and/or fractures
Functional discrepancy of limb length
Patient who not able to stand
Associated hip pathology
Inflammatory arthritis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the prevalence of low back pain in patients with end stage knee arthritis undergoing TKR.
Influence on back pain on the functional outcome after TKR and vice versa.
|
6 months and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in spinopelvic parameters post TKR (Simultaneous & Staggered).
To compare the radiological changes and PROM in matched cohort population with and without LBA.
|
6 months and 1 year |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
07/10/2019 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All the patients undergoing primary TKR meeting inclusion criteria with or without LBA during study period were taken into study. Group A: With the low backache Group B: Without low backache (control group) All the patients were clinically examined and functional scores recorded. The scores taken were VAS score for pain, Oswestry disability index for back pain, SF-12 for patient-reported outcome measure and Knee society score for knee function. Radiologically, Both groups- Standard TKR Protocol radiographs ( Alignment Xray, Knee Anteroposterior and skyline views) taken. •Whole spine Xray- AP, lateral (Standing) •Dynamic views – if symptomatic •MRI ( to stratify based on diagnosis)- if symptomatic The patient will undergo standard total knee replacement and postoperative protocol. After total knee replacement, both groups assessed with clinical scores and radiological criteria at 6 months and 1 year follow up. Statistical analysis used for comparison between groups: • Student’s t-test for continuous variables • Chi-squared test and Fisher’s exact test for categorical variables. For comparison between pre- and postoperative data within a group: • Paired t-test or Wilcoxon signed-rank test • Correlation- assessed by the Spearman coefficient. • Statistical significance was considered for P values less than 0.05 |