Clinial Application of Park et al.(The Knee 27 (2020) 1577-1584)'s Study

NCT05202847 | Withdrawn

• 1 other identifier: 3-2021-0432
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study was to perform pulsed radiofrequency ablation with a modified target suggested in the cadaver study by Park et al. (The Knee 27 (2020) 1577-1584) on knee osteoarthritis patients, and to evaluate the effect of reducing the frequency of intravascular injection and reducing pain.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The rate at which vascular uptake is confirmed when the first contrast agent is given after the needle is positioned at the target point

  Whether vascular uptake is confirmed on the x-ray image is a binary response.

  during the ablation procedure

Secondary Outcomes (4)

• numeric rating score

  Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation

• functional status

  Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation

• quality of life

  Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation

• medication

  Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation

Study Arms (2)

pulsed radiofrequency ablation to modified points group

EXPERIMENTAL

pulsed radiofrequency ablation aimed at the adjusted target point of Park et al. under C-arm guidance

Procedure: pulsed radiofrequency ablation to modifined points group

pulsed radiofrequency ablation to conventional points group

ACTIVE COMPARATOR

pulsed radiofrequency ablation aimed at conventional target point under C-arm guidance

Procedure: pulsed radiofrequency ablation to conventional points group

Interventions

pulsed radiofrequency ablation to modifined points group PROCEDURE

Point 1 place 10mm higher than the boundary between Femur's medial epicondyle and shaft. The 2nd point is targeted 20mm above the patella. Point 3 is targeted 10mm above the femur lateral epicondyle and shaft boundary. At point 4, find the boundary position between the tibia epicondyle and the shaft in the AP view and move it superolateral by 10 mm to target the central part of the medial shaft of the tibia and perform the main touch. Point 5 targets the center of the fibular head.

pulsed radiofrequency ablation to modified points group

pulsed radiofrequency ablation to conventional points group PROCEDURE

Under AP view X-ray fluoroscopy, enter the cannula into the tunnel view until reaching the bone, reaching the border of the shaft and epicondyle, then stop the cannula tip at the anterior 2/3 junction in the lateral view. A total of three target points are the boundary position between the femur medial epicondyle and the shaft, the boundary position between the femur lateral epicondyle and the shaft, and the boundary position between the tibia meidal epiconcyle and the shaft. Subsequent procedure will be proceed same as Arm 1

pulsed radiofrequency ablation to conventional points group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic knee pain that does not respond to conservative treatment (physiotherapy, oral analgesic, steroid intra-articular injection, Hyruan injection) for more than 6 months
• A score of 6 or higher (out of 10) on the target knee's numerical rating scale
• Knee osteoarthritis 1-4 confirmed in knee X ray within 6 months of study enrollment

You may not qualify if:

• Systemic inflammatory diseases such as rheumatic diseases
• uncontrolled diabetes
• malignant tumor
• If the target knee has a previous surgical history (arthroscopy, arthroscopy, autologous or allograft osteochondral transplantation and autologous cartilage cell transplantation, osteotomy, arthritis surgery)
• Patients with lidocaine and contrast agent allergy
• history of nerve block in the target knee within 2 weeks
• Body mass index over 40 kg/m2
• bleeding disorder
• Pregnant/lactating women
• Inability to understand informed consent and respond to research questionnaires due to cognitive impairment
• Unable to read consent form (e.g. illiterate, foreigner, etc.)

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Medical staff performing patient care, including pain management, and investigators who investigate and record observations and evaluations, and participants are kept unaware of group assignments.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share