| CTRI Number |
CTRI/2026/01/102256 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A Study Comparing Traditional and Robotic Knee Replacement Surgery in People with Arthritis in Both Knees |
|
Scientific Title of Study
|
To compare clinical and radiological outcomes of
conventional and robotic total knee replacement in patients with osteoarthritis of bilateral knee joint Academic trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raghunath S |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
OPD- 236
AIIMS MANGALAGIRI, Mangalagiri, Andhra Pradesh 522503 Guntur ANDHRA PRADESH 522503 India |
| Phone |
8098768903 |
| Fax |
|
| Email |
m02jan025026@aiimsmangalagiri.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Nataraj A R |
| Designation |
Professor and Head of the department Orthopaedic |
| Affiliation |
AIIMS Mangalagiri |
| Address |
OPD-236
AIIMS MANGALAGIRI, Mangalagiri, Andhra Pradesh 522503 Guntur ANDHRA PRADESH 522503 India |
| Phone |
9482183670 |
| Fax |
|
| Email |
natadoc@aiimsmangalagiri.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Nataraj A R |
| Designation |
Professor and Head of the department Orthopaedic |
| Affiliation |
AIIMS Mangalagiri |
| Address |
OPD-236
AIIMS MANGALAGIRI, Mangalagiri, Andhra Pradesh 522503 Guntur ANDHRA PRADESH 522503 India |
| Phone |
9482183670 |
| Fax |
|
| Email |
natadoc@aiimsmangalagiri.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS Mangalagiri
MAngalagiri,
Guntur,
Andhra Pradesh- 522503
India |
|
|
Primary Sponsor
|
| Name |
Dr Raghunath |
| Address |
OPD- 236
AIIMS Mangalagiri
Mangalagiri, Guntur
Andhra Pradesh 522503 |
| Type of Sponsor |
Other [Self Funding] |
|
|
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 Raghunath S |
Room no.236, Second floor, Orthopaedics Department, AIIMS Mangalagiri |
AIIMS MANGALAGIRI,
Mangalagiri, Andhra Pradesh 522503 Guntur ANDHRA PRADESH |
08098768903
m02jan025026@aiimsmangalagiri.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS MANGALAGIRI |
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 |
| Comparator Agent |
Conventional Total knee Replacement |
Manually total knee replacement will be done |
| Intervention |
Robotic Total knee Replacement |
Robot assisted knee replacement will be done |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients diagnosed with bilateral knee osteoarthritis with varus deformity .
b) patients aged between 50 and 80 years and also medically fit for bilateral TKR .
c) patient with ROM difference between bilateral knee not more than 10 degree and varus deformity difference less than 5 degree.
d) Patients willing to undergo one knee conventional and other knee robotic TKR after understanding all the possible complications and gives audiovisual consent for the procedure.
|
|
| ExclusionCriteria |
| Details |
a) Patients with inflammatory arthritis (e.g., rheumatoid arthritis).
b) Patients with a history of knee infections or previous knee surgeries.
c) patient with neuromuscular disorders affecting lower limb function .
d) Patients with fixed deformities of the knee joint
e) Patients with any contraindications for surgery like severe cardiac ,renal ,pulmonary and any other severe systemic illness.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• To evaluate and compare functional outcomes by using standardised scoring systems- WOMAC ,OKS , VAS at defined postoperative intervals .
• To assess radiological outcomes such as implant positioning and alignment between robotic and conventional TKR using HKA angle, femoral coronal component angle (FFC),tibial coronal component angle (FTC),posterior tibial slope angle (PSA).
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To compare operative parameters such as duration of surgery , intra operative blood loss and need for soft tissue releases between robotic and conventional TKR |
on the day of surgery |
|
|
Target Sample Size
|
Total Sample Size="25" Sample Size from India="25"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/02/2026 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Comparing clinical and radiological outcomes of conventional and robotic total knee replacement (TKR) in patients with bilateral knee osteoarthritis is a pertinent area of research given the increasing adoption of robotic assistance. This type of study typically aims to determine if the perceived precision and potential benefits of robotic-assisted surgery translate into superior patient outcomes compared to traditional manual techniques. A well-designed study would involve a cohort of patients suffering from end-stage osteoarthritis affecting both knees. These patients would ideally undergo TKR using both conventional and robotic techniques, either with one knee receiving conventional and the other robotic (a within-patient comparison, carefully considering potential confounding factors), or by randomizing patients to receive either conventional or robotic surgery for both knees. The primary clinical outcomes would include patient-reported outcome measures (PROMs) such as the Knee Society Score (KSS), Oxford Knee Score (OKS), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). These scores capture pain levels, functional limitations, and overall patient satisfaction, providing a holistic view of the recovery process and quality of life post-surgery. Range of motion and gait analysis would also be critical clinical assessments. Radiological outcomes would focus on implant positioning and alignment, which are hypothesized to be more precise with robotic assistance. This would involve post-operative X-rays and potentially CT scans to assess parameters like component angles (femoral and tibial), joint line restoration, and mechanical axis alignment. The incidence of malalignment or outliers beyond acceptable ranges would be a key comparative metric. Secondary outcomes could include surgical time, blood loss, length of hospital stay, and complication rates (e.g., infection, deep vein thrombosis, revision surgery). The study would need to ensure adequate follow-up periods (e.g., 1, 2, and 5 years) to evaluate long-term implant survival and functional stability. While robotic assistance often promises enhanced precision, the core question is whether this translates into clinically meaningful benefits for patients, such as reduced pain, improved function, and greater implant longevity, compared to the well-established conventional method. The findings would help inform surgical decision-making and potentially guide future advancements in TKR techniques. |