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Radio-frequency Ablation in Knee Osteoarthritis by Three Needles Technique

A

Alaa Fouli Gaber Ebrahim

Status

Unknown

Conditions

Knee Osteoarthritis

Treatments

Radiation: Radio-frequency ablation of genicular nerves

Study type

Interventional

Funder types

Other

Identifiers

NCT03613610
60-2/2018

Details and patient eligibility

About

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. Pain intensity via the visual analogue score (VAS).
  2. Function and pain via the Oxford Knee Score. Evaluated after 6 months of the procedure

Secondary outcome:

  1. Failure rate.
  2. Incidence of any complication.
  3. Total analgesic requirement during the period of follow up.

Enrollment

50 patients

Sex

All

Ages

35 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 1- 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).

Exclusion criteria

  • 1- 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.

    5- 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Three needles group
Active Comparator group
Treatment:
Radiation: Radio-frequency ablation of genicular nerves
Single needle group
Active Comparator group
Treatment:
Radiation: Radio-frequency ablation of genicular nerves

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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