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CTRI Number  CTRI/2025/10/096673 [Registered on: 30/10/2025] Trial Registered Prospectively
Last Modified On: 11/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Medical Device 
Study Design  Other 
Public Title of Study   A Study to Check the Safety, tolerability and Efficacy of Intra-Articular Injection of Hydrogel OA 2% in for the treatment of Patients with Knee Osteoarthritis. 
Scientific Title of Study   A Prospective, Single-Center, Non-Randomized, Open-Label Pilot Study to Evaluate the Safety, tolerability and Efficacy of Intra-Articular Injection of Hydrogel OA 2% in for the treatment of Patients with Knee Osteoarthritis. 
Trial Acronym  ALFHA-K 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
AL-OA-CT01-25 Final version 2.0, Date- 27 Jan 2026   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunil Maheshwari  
Designation  Principal Investigator 
Affiliation  Prime care Hospital 
Address  B-403/404,4th floor,B-wing, Rudra Arcade, Helmet char rasta, near Mayflower & Sunflower hospital, Drive In Rd, above Indian Bank, Memnagar, Ahmedabad, Gujarat 380052

Ahmadabad
GUJARAT
380052
India 
Phone  9898983555  
Fax    
Email  drsunilmaheshwari10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sornaraja Thasma  
Designation  Director Quality & Business 
Affiliation  ProRelix Services LLP 
Address  102 A/B, Park Plaza, Chowk, State Bank Nagar, Sramik Vasahat, Karvenagar, Pune, Maharashtra 411052

Pune
MAHARASHTRA
411052
India 
Phone  8124806366  
Fax    
Email  s.thasma@prorelixresearch.com  
 
Details of Contact Person
Public Query  
Name  Mrs Aditi Vaidya  
Designation  Senior Manager- Clinical Research Operations 
Affiliation  ProRelix Services LLP 
Address  102 A/B, Park Plaza, Chowk, State Bank Nagar, Sramik Vasahat, Karvenagar, Pune, Maharashtra 411052

Pune
MAHARASHTRA
411052
India 
Phone  8602571013  
Fax    
Email  a.vaidya@prorelixresearch.com  
 
Source of Monetary or Material Support  
Allegro NV/SA, Boulevard Patience et Beaujonc 3/21, B-4000 Liège, Belgium  
 
Primary Sponsor  
Name  Allegro NV/SA 
Address  Boulevard Patience et Beaujonc 3/21, B-4000 Liège, Belgium 
Type of Sponsor  Other [Biomedical Technology] 
 
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 
Dr Sunil Maheshwari   Prime care Hospital   B-403/404,4th floor,B-wing, Rudra Arcade, Helmet char rasta, near Mayflower & Sunflower hospital, Drive In Rd, above Indian Bank, Memnagar, Ahmedabad, Gujarat 380052
Ahmadabad
GUJARAT 		 9898983555

drsunilmaheshwari10@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medilink Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Hydrogel OA 2%  One single injection of 1 mL Hydrogel OA 2% will be injected into the knee joint at Day 1. 
Intervention  Hydrogel OA 2%  One single injection of 2 mL Hydrogel OA 2% will be injected into the knee joint at Day 1.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Adults accepting to participate in the study and having signed the written informed consent form before any protocol-specific procedures and able to understand and follow the instructions as described in the protocol.
2. Unilateral symptomatic tibiofemoral KOA confirmed by a standing knee X-ray. In case of bilateral KOA on X-ray only one knee (index knee) presents symptomatic OA pain.
3. Age 35 more than equal to 75 years.
4. BMI 20 more than equal to 35.
5. KOOS Pain score 25 more than equal to 85.
6. Radiological K and L grade II and III from a standing index knee radiograph .
7. Fully ambulatory for functional assessments.
8. Willingness to refrain from taking any pain medication for 48 hours prior intraarticular injection.
9. Female participants must be on effective contraception (pill, patch, ring, diaphragm, implant or intrauterine device), if not surgically
sterile (tubal ligation or hysterectomy) or postmenopausal for at least one year. If none of these criteria are met a pregnancy test must be performed at the treatment visit and the result should be negative.  
 
ExclusionCriteria 
Details  1. Bilateral tibiofemoral KOA where the non-index knee presents worse radiological grade of KOA than the index knee.
2. Radiological Kellgren and Lawrence grade 0, I, or IV of the index knee from a standing knee radiograph assessed during the screening visit, using the most recent x-ray taken either immediately or within the past 3 months. Significant clinically assessed varus or valgus deformation of the selected knee side of more than 10 degrees.
3. Extension deficit of the index knee higher than 5 degrees.
4. Bilateral symptomatic tibiofemoral KOA or ipsilateral symptomatic tibiofemoral knee and hip OA.
5. Clinical signs of significant effusion with noticeable swelling and/or inflammation related to severe pain during the treatment visit.
6. Active lymphatic or venous stasis or serious blood disorders (e.g., anemia), bleeding disorders (e.g., hemophilia), blood clots, or blood cancers (e.g., leukemia, lymphoma, and myeloma).
7. Active bacterial infection, resulting in hospitalization and/or requiring intravenous antibiotic treatment.
8. Synovial infection, skin infection or skin diseases in the area of the injection site.
9. History of autoimmune diseases that causes chronic joint pain and inflammation in the knee joint, including rheumatoid arthritis, psoriasis arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, gout, pseudogout, systemic sclerosis, Sjögren disease, adult-onset still disease.
10. Known or suspected generalized chronic pain disorder.
11. Severe alteration of mobility preventing any functional assessment.
12. Allergy or hypersensitivity to any of the product components of Hydrogel OA 2%.
13. Conditions (orthopedic, rheumatologic, musculoskeletal or inflammatory) causing symptomatic and/or radiating pain in the lower extremities that might interfere with the symptomatic OA knee pain, including hip OA assessed by physical examination by the physician.
14. Symptomatic patellofemoral KOA.
15. Oral corticosteroid therapy in the last 3 months before injection.
16. Severe acute illness within 14 days prior to investigational device administration.
17. Regular/chronic use of opioid drugs for pain control during the last 3 months before screening.
18. Use of opioid drugs within 7 days prior to the treatment visit. (However, opioid medications may be used for pain control during the study period.)
19. Pain Catastrophizing Scale score of 30 or higher than 30.
20. Any intra-articular injection (hyaluronan, hydrogel, soft implant, corticosteroid, platelet-rich plasma, local anesthetic etc.) arthroscopy, surgery in the index knee; or cell-based therapy or an invasive procedure on the index knee in the last 6 months before screening visit.
21. Anticipated need for any surgical or other invasive procedure throughout the course of the clinical investigation, including prosthesis
in the index knee, any concurrent OA treatments including alternative treatments (e.g., acupuncture, ultrasound, magnetic resonance etc.).
22. Any investigator-assessed clinically significant condition that may represent a substantial risk to the patient or may have an impact on the study assessments.
23. Participation in another clinical trial in the last 3 months before injection.
24.Pregnancy and breastfeeding.
25.Legal incapacity or limited legal capacity to consent.
26. Trauma of the index knee in the last 6 months before the treatment visit.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The occurrence of any device or procedure related (serious) adverse event within 3 months after injection of the device.  Day 1 to Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
The occurrence of any device or procedure related (serious) adverse event within 12 months after injection of the device.  Day 1 to Day 365 
 
Target Sample Size
Modification(s)  		 Total Sample Size="30"
Sample Size from India="30" 
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)   20/11/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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
Modification(s)  

This  study aims to evaluate the safety, tolerability and efficacy of one intra articular injection of Hydrogel OA 2% for the symptomatic treatment of KOA between the age group of 35 to 75 years.  The trial will be a open-label, single-center, non-randomized, double-arm prospective investigator initiated trial clinical investigation study consisting of 30 participant. Each participant will injected with one intra articular injection of Hydrogel OA 2% at day 1 (treatment visit), there will be a follow up period on one year from treatment visit for each participant. 

 
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