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Assessment of the prevalence and characterization of osteoarthritis in Kandy four Gravets and Gangawata Korale in the Kandy district and to assess the outcome of Genicular artery embolization in grade 3 and 4 knee osteoarthritis

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SLCTR Registration Number

SLCTR/2024/001


Date of Registration

01 Feb 2024

The date of last modification

Feb 01, 2024



Application Summary


Scientific Title of Trial

Assessment of the prevalence and characterization of osteoarthritis in Kandy four Gravets and Gangawata Korale in the Kandy district and to assess the outcome of Genicular artery embolization in grade 3 and 4 knee osteoarthritis


Public Title of Trial

Assessment of prevalence and characterization of osteoarthritis in four Gravets and Gangawata Korale in the Kandy district and a randomized control trial to assess the effectivity of embolization of genicular artery vs standard care to relieve pain in Kellgren-Lawrnce grade 3 & 4 osteoarthritis among patients attending the rheumatology clinic at Teaching Hospital Peradeniya


Disease or Health Condition(s) Studied

Osteoarthritis


Scientific Acronym


Public Acronym


Brief title

Effectivity of embolization of the genicular artery vs standard care to relieve pain in Kellgren-Lawrnce grade 3 & 4 osteoarthritis.


Universal Trial Number

U1111-1299-8844


Any other number(s) assigned to the trial and issuing authority

2023/EC/15


Trial Details


What is the research question being addressed?

How effective is Genicular artery embolization in the management of patients with Kellgren-Lawrnce grade 3 and 4 primary knee osteoarthritis with severe knee pain compared to standard conservative management in patients attending the Rheumatology clinic at teaching hospital Peradeniya?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Treatment


Study Phase

Phase 2


Intervention(s) planned

Study setting: This will be a single-centre study that will be carried out at the Rheumatology clinic, radiology unit and the medical ward at Teaching Hospital Peradeniya and in the research laboratory of the Department of Medicine, Faculty of Medicine, University of Peradeniya

Method of Randomization: A random number generator will be used to generate 2 equal sets of numbers from a sequence of 1 to 66. Each patient will be allocated a number at study entry by sequential number allocation. They will be placed in the treatment group or the control group based on the random sequence gene3qrated number strings. To ensure true randomization without bias, a research assistant employed by the Department of Medicine who is not involved in the rest of the study, will be handling random number generator and the patient number allocation.

Details of intervention group: Percutaneous common femoral arterial (CFA) access will be obtained using a 5F introducer sheath. The CFA will be punctured in an ipsilateral anterograde fashion. In case of difficult access, retrograde contralateral approach will be used. Intra venous heparin 2,500 IU will be given to the introducer sheath. By using a 4F angiographic catheter popliteal artery digital subtraction angiography will be performed by manually injecting 6 to 8 mL of iodinated contrast medium. The descending genicular artery, superior and inferior lateral genicular arteries, superior and infero-medial genicular arteries, and the median genicular artery will be demonstrated in all subjects. After localizing the abnormal neo-vasculature and contrast blush, the catheter will be selectively placed in the targeted arteries and the embolic agent (100 micron polyvinyl alcohol particles) will be injected until optimal embolization is achieved. The procedure will be carried out as a day case by the consultant radiologist (interventional). The intervention group will receive standard conservative treatment.

Details of conservative treatments: Conservative treatments are based on physiotherapy therapeutic measures, weight management, orthopedic aids, topical or oral non steroids anti-inflammatory drugs (NSAIDs), intra articular corticosteroids and lifestyle modification. The above treatment modalities will be invidualised to the patient based on clinical assessment.

Details of control group: This group will only receive conservative treatment,


Inclusion criteria

• Males and females with an age above 30 years • Kelgren-Lawrence (KL) radiographic grading system- grade 3 and 4 knee osteoarthritis • Primary knee OA • Knee pain (>6 on visual analog scale) on at least half of the days in the preceding month at the time of inclusion • Registered patient in rheumatology clinic with at least 6 months of standard medical treatments


Exclusion criteria

• Individual without the mental capacity to consent • Pregnant or lactating individuals • Secondary osteoarthritis (due to inflammatory arthritis) • Contraindication for angiography (ex: coagulopathy, renal insufficiency, contrast allergy) • Previous surgical treatments for knee OA (eg: high tibial osteotomy) excluding knee arthroscopy. • Musculoskeletal comorbidity (e.g: Rheumatoid arthritis or gout) potentially masking the effect of GAE.



Primary outcome(s)

1.

Improvement in pain as described by the Visual Analog Scale (VAS)

[

Baseline, 1 month, 3 months, 6 months and 1 year

]

Secondary outcome(s)

1.

Western Ontario and McMaster Universities Arthritis Index (WOMAC) functional status assessment. This is used in the evaluation of Hip and Knee Osteoarthritis. It is a questionnaire consisting of 24 items divided into 3 subscales: pain, stiffness and physical function of the subject.

[

Baseline, 1 month, 3 months, 6 months and 1 year

]
2.

Muscle strength as measured by the Medical Research Council (MRC) scale of Quadriceps and Hamstring muscle.

[

Baseline, 1 month, 3 months, 6 months and 1 year

]
3.

Joint range-of-motion as assessed by the goniometer around the knee.

[

Baseline, 1 month, 3 months, 6 months and 1 year

]
4.

Quality of life as measured by the Short form health survey (SF-36) questionnaire

[

Baseline, 1 month, 3 months, 6 months and 1 year

]

Target number/sample size

66 (33 in each arm)


Countries of recruitment


Anticipated start date

2024-02-02


Anticipated end date

2025-05-23


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2023-09-23


Approval number

2023/EC/15


Details of Ethics Review Committee

Name: Ethic review committee, Faculty of medicine, University of Peradeniya
Institutional Address:Faculty of Medicine, University of Peradeniya 34 Galaha Rd, Kandy
Telephone:0812396361
Email: chairperson.erc@med.pdn.ac.lk

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

H. K. Rumesh Priyadarshana
Physiotherapist
Department of Physiotherapy, National Hospital of Sri Lanka, Kandy
0812244835
0715652475

rumeshphysio@gmail.com

Contact Person for Public Queries

Dr Chathurika Dandeniya
Senior Lecturer in Medicine and Consultant in Rheumatology and Rehabilitation
Department of Medicine, Faculty of Medicine, University of Peradeniya

0718207196

chathurika.dandeniya@yahoo.com


Primary study sponsor/organization

Faculty of Medicine, University of Peradeniya





Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results