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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 â€“ 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

 
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