| CTRI Number |
CTRI/2024/06/069608 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Difference in outcomes in people undergoing patella/knee cap modification in total knee replacement |
|
Scientific Title of Study
|
Comparative functional outcomes of resurfacing of Patella in patients
undergoing Posterior stabilized versus Cruciate retaining Total Knee Arthroplasty: A non-randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shashank Suman |
| Designation |
Junior resident |
| Affiliation |
AIIMS Bathinda |
| Address |
Room No-114, PG Hostel AIIMS Bathinda, Mandi dabwali road, Bathinda, punjab. pin -151001.
Bathinda
PUNJAB
151001
India |
| Phone |
8507208662 |
| Fax |
|
| Email |
Shashanksuman49@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tarun Goyal |
| Designation |
Professor and head of department |
| Affiliation |
Aiims Bathinda |
| Address |
Dept of orthopaedics,AIIMS Bathinda, Mandi dabwali road, Bathinda, punjab. pin -151001.
Bathinda
PUNJAB
151001
India |
| Phone |
8475000283 |
| Fax |
|
| Email |
goyal.tarun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tarun Goyal |
| Designation |
Professor and head of department |
| Affiliation |
Aiims Bathinda |
| Address |
Dept of orthopaedics,AIIMS Bathinda, Mandi dabwali road, Bathinda, punjab. pin -151001.
Bathinda
PUNJAB
151001
India |
| Phone |
8475000283 |
| Fax |
|
| Email |
goyal.tarun@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS BATHINDA, Mandi-Dabwali road, bathinda,punjab, India
PIN code-151001 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 |
| Shashank Suman |
AIIMS BATHINDA |
Orthopedics dept room no 2025, Mandi dabwali road, bathinda punjab 151001
Bathinda
PUNJAB |
8507208662
Shashanksuman49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All india institute of medical sciences, bathinda 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
|
| Type |
Name |
Details |
| Intervention |
Arm 1 -Patella resurfacing in Posterior stabilised Total knee arthroplasty |
Patient will be undergoing Patella resurfacing in PS TKR and will be Followed up for 6weeks |
| Intervention |
Arm 2 -Patella resurfacing in cruciate retaining Total knee arthroplasty |
Patient will be undergoing Patella resurfacing in CR TKR and will be followed up for 6weeks |
| Comparator Agent |
Arm 3 -Patella non-resurfacing in Posterior stabilised Total knee arthroplasty |
Patient will not be undergoing Patella resurfacing in PS TKR and will be followed up for 6weeks |
| Comparator Agent |
Arm 4 -Patella non-resurfacing in Cruciate retaining Total knee arthroplasty |
Patient will not be undergoing Patella resurfacing in CR TKR and will be followed up for 6weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of age between 50-75 years.
Either gender.
Patient with primary Osteoarthritis knee varus deformity with knee. |
|
| ExclusionCriteria |
| Details |
Knee with secondary osteoarthritis.
Revision total knee arthroplasty.
Previous patellar fracture/ Patella replacement.
Hip and ankle pathology
Previous fracture around knee.
Osteomyelitis knee/ Inflammatory arthritis.
Patella femoral instability. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparision of functional outcomes of patella resurfacing and non resurfacing in Total knee arthroplasty |
preop, postop, 6weeks, 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparision of functional outcomes in patients undergoing PS and CR TKR |
preop, postop, 6week, 6months |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
Final Enrollment numbers achieved (Total)= "122"
Final Enrollment numbers achieved (India)="122" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| Date of Study Completion (India) |
24/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
AIM- To compare functional outcomes of patellar resurfacing between PS and CR TKA in patients undergoing primary TKA
Methods- A non randomized Clinical trial at tertiary center including 122 patients fulfilling inclusion criteria. Patients were allocated sequentially into four groups. Outcomes assesed preoperatively, at 6weeks and at 6months.
Results- Patellar resurfacing significantly increased surgical duration. KOOS scores showed consistent postoperative superiority in resurfacing groups at both follow ups with maximal improvement in PS resurfacing patients. WOMAC and VAS scores improved significantly without significant intergroup differences. ROM at 6 weeks and 6months was significantly higher in PS and PS resurfacing cohorts. Kujala scores were significantly higher in resurfacing groups at both follow ups, with maximal improvement in PS resurfacing patients.
COnclusion- Patellar resurfacing combined with PS design provides modest early benefit in ROM, patellofemoral function and KOOS outcomes. However by 6 months, overall functional recovery is similar across all groups. All surgical approaches yielded substantial pain relief and high patient satisfaction |