| CTRI Number |
CTRI/2025/06/088633 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
"Can You Treat Knee Arthritis Without Surgery? Looking at Genicular Artery Embolization" |
|
Scientific Title of Study
|
Genicular Artery Embolization: Evaluating Its Efficacy as a Non-Surgical Treatment for Chronic Knee Pain in osteoarthritis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yugandhar Samireddypalle |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences - Mangalagiri |
| Address |
Department of radiodiagnosis
All India Institute of Medical Sciences
Mangalagiri
Guntur
Guntur
ANDHRA PRADESH
522501
India |
| Phone |
9930237652 |
| Fax |
|
| Email |
yugu.samireddypalle@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yugandhar Samireddypalle |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences - Mangalagiri |
| Address |
Department of Radiodiagnosis,
All India Institute of Medical Sciences
Mangalagiri
Guntur
Guntur
ANDHRA PRADESH
522501
India |
| Phone |
9930237652 |
| Fax |
|
| Email |
yugu.samireddypalle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yugandhar Samireddypalle |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences - Mangalagiri |
| Address |
Department of Radiodiagnosis
All India Institute of Medical Sciences
Mangalagiri
Guntur
Guntur
ANDHRA PRADESH
522501
India |
| Phone |
9930237652 |
| Fax |
|
| Email |
yugu.samireddypalle@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of medical sciences, Mangalagiri |
|
|
Primary Sponsor
|
| Name |
All India institute of medical sciences Mangalagiri |
| Address |
Guntur 522501 |
| 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 |
| Yugandhar Samireddypalle |
All India Institute of Medical Sciences |
Department of radiodiagnosis, AIIMS, Mangalagiri
Guntur
ANDHRA PRADESH |
9930237652
yugu.samireddypalle@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, Mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Genicular artery Embolization |
Genicular Artery Embolization is a minimally invasive procedure where tiny PVA particles are injected into knee arteries to reduce blood flow, inflammation, and pain. It is done under flouro guidance, usually under local anesthesia, with quick recovery and minimal risks. |
| Comparator Agent |
NO TREATMENT |
As its an early Phase trial, Only Observation is done |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Symptomatic patients aged 40 years and older diagnosed with Chronic OA knee based on clinical features and Knee radiographs. (Kellen- Lawrence Grade 1-3)
2. Failed medical management for OA knee.
3. Unwilling to Undergo TKA/ Not surgically fit for TKA.
|
|
| ExclusionCriteria |
| Details |
1. Kellen – Lawrence Grade 4 on Knee radiograph
2. Active Knee infection
3. Underlying Inflammatory arthritis
4. Severe Peripheral Vascular disease (PVD)
5. Allergy to contrast media
6. Severe renal Impairment (eGFR less than 30 ml/min/1.73m2)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At least 25% improvement in the WOMAC and KOOS scores , post intervention |
1 month, 3 months and 6 months post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteoarthritis (OA) of the knee is a degenerative condition leading to chronic pain and reduced quality of life. Traditional treatments include non-steroidal anti-inflammatory drugs, intraarticular injections, and, ultimately, Total Knee Arthroplasty (TKA) for severe cases. However, TKA carries risks and prolonged recovery. Genicular Artery Embolization (GAE) is emerging as a minimally invasive alternative that targets neovascularization and inflammatory processes driving OA symptoms. This project evaluates the efficacy, safety, and outcomes of GAE in improving quality of life for patients with chronic knee OA who are refractory to medical therapy. Through literature review, clinical procedures, and patient follow-up, the study aims to assess symptom reduction, cost-effectiveness, and predictors of successful outcomes. The work involves a longitudinal study with a calculated sample size of 21 patients, evaluating symptom changes via WOMAC and KOOS scores over three months. Data analysis includes paired t-tests and repeated measures ANOVA to determine significance. If proven effective, GAE may offer a safer, faster-recovery alternative to surgical interventions, reshaping OA management and expanding minimally invasive options. This study is especially relevant in India, where GAE is still emerging, and could drive future research into its broader clinical application. |