Radio-frequency Ablation in Knee Osteoarthritis by Three Needles Technique

NCT03613610 | Unknown DMC

• 1 other identifier: 60-2/2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to evaluate and compare the efficacy of three needles approach as a new technique in radiofrequency neurotomy of genicular nerve versus the traditional single needle approach as a treatment of advanced knee osteoarthritic pain. Primary outcome:

1. 1.Pain intensity via the visual analogue score (VAS).
2. 2.Function and pain via the Oxford Knee Score. Evaluated after 6 months of the procedure
3. 3.Failure rate.
4. 4.Incidence of any complication.
5. 5.Total analgesic requirement during the period of follow up.

Conditions

Knee Osteoarthritis

Keywords

Genicular nerve radio-frequency ablation

Outcome Measures

Primary Outcomes (2)

• Visual analogue score

  Pain intensity via the visual analogue score (VAS).

  6 months after the procedure

• Oxford knee score

  Follow up of pain and function via the Oxford knee score

  6 months after the procedure

Secondary Outcomes (2)

• Failure rate

  6 months after the procedure

• Incidence of complication

  6 months after the procedure

Study Arms (2)

Three needles group

ACTIVE COMPARATOR

Radiation: Radio-frequency ablation of genicular nerves

Single needle group

ACTIVE COMPARATOR

Radiation: Radio-frequency ablation of genicular nerves

Interventions

Radio-frequency ablation of genicular nerves RADIATION

Ablation of the genicular nerves for pain relief in advanced knee osteoarthritis

Single needle group; Three needles group

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 35-85 years old 2- Patients with stage 3 or higher OA-related radiological changes based on Kellgren-Lawrence (K/L) rating scale 3- Knee pain for at least 3 months 4-Patients are clinically unresponsive to conservative treatment modalities (physical therapy and rehabilitation practices, orally administered analgesics and anti-inflammatory drugs).

You may not qualify if:

• Patients with other causes of pain as radiculopathy, neurological disorders or intermittent claudication. 2- Previous knee trauma. 3- Previous knee surgery. 4- Patients received intra-articular injection during the previous three months.
• Acute knee pain. 6- Crystal arthropathy. 7- Joint effusion. 8- Serious neurological or psychiatric disorders. 9- On anticoagulant medication. 10- Any other connective tissue disorder that affects the knee joint. 11- skin infection at the site of injection. 12-patient refusal.

Sponsors & Collaborators

• Alaa Fouli Gaber Ebrahim: lead

Study Sites (1)

Faculty of Medicine, minia university

Minya, 61111, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Omyma Sh Mohamed, Ass. prof.

  Minia University

  STUDY DIRECTOR

• And El raheem Ma Mohamed, Lecturer

  Assist university

  STUDY CHAIR

• Sarah Mo Omar, Lecturer

  Minia University

  STUDY CHAIR

• Alaa Fo Gaber, Resident

  Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident of anesthesia and intensive care

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 3, 2018
• Study Start: February 26, 2018
• Primary Completion: August 1, 2018
• Study Completion: November 1, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

EG (1)