Effectiveness of Percutaneous A1 Pulley Release Under Ultrasound Guidance Associated With Infiltration, Versus Infiltration Alone, in Patients With Trigger Finders Who Have Failed a First Infiltration: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Effectiveness of pulley section with ultrasound guidance combined with corticosteroid infiltration versus corticosteroid alone on complete resolution of trigger finger's symptoms
研究概览
简要总结
Trigger finger is a mechanical problem characterized by pain and catching of digit in flexion.
Histological changes of A1 pulley and synovial proliferation have been identified as factors that prompt trigger finger The first-line treatment of trigger finger is conservative with splinting and corticosteroid injection.
If the first infiltration fails, either a second infiltration or surgical sectioning of the pulley is proposed.
Surgery can be performed by several techniques (open section, percutaneous section with palpatory guidance, or under ultrasound guidance).
Percutaneous A1 pulley release under ultrasound guidance consists of cutting the A1 pulley by a percutaneous insertion with small needle under local anaesthesia.
The hypothesis of the study is that percutaneous A1 pulley release under ultrasound guidance followed by a corticosteroid injection would be more effective than a second corticosteroid injection alone on complete resolution of the trigger finger symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 years old,
- •Presence of a trigger finger (thumb or long fingers) to be treated
- •Quinnell score >1
- •Episode of trigger characterized on questioning or clinical examination
- •Failure of a first corticosteroid infiltration > 3 months before inclusion
- •First infiltration within 15 months of inclusion
- •Thickening A1 pulley on ultrasound ≥ 0.5 mm
- •Patient who has the capacity to understand the protocol and has given consent to participate in the research,
- •Patient with social security coverage
排除标准
- •Presence of several symptomatic fingers requiring treatment by ultrasound-guided section of the pulley
- •Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception at the time of inclusion
- •Known allergy to corticoid (Hydrocortancyl®) including its excipients ((benzyl alcohol, sodium carmellose, sodium chloride, polysorbate 80)
- •Known allergies to lidocaine
- •Ongoing anticoagulant treatments (AVK, New Oral Anti-Coagulants)
- •Local or general infection, or suspicion of infection
- •Live vaccines
- •Evolving viruses (hepatitis, herpes, varicella, shingles)
- •Severe or uncontrolled hypertension
- •Unbalanced diabetes
- •Underlying progressive cardiovascular disease
- •Hemodialysis patients
- •Prosthesis on the finger to be treated
- •Echographic tendon fissure
- •Inflammatory disease (rheumatoid arthritis, spondyloarthritis, connective tissue diseases, etc.) with tenosynovitis.
- •History of surgery on the fingers
- •Dupuytren's disease
- •Patient participating in another interventional clinical research protocol involving a drug or medical device
- •Patient under guardianship, curators or legal protection
研究组 & 干预措施
percutaneous A1 pulley release with corticosteroid injection
干预措施: Percutaneous A1 Pulley Release Under Ultrasound Guidance (Procedure)
percutaneous A1 pulley release with corticosteroid injection
干预措施: Corticosteroid injection (Drug)
corticosteroid injection alone
干预措施: Corticosteroid injection (Drug)
结局指标
主要结局
Effectiveness of pulley section with ultrasound guidance combined with corticosteroid infiltration versus corticosteroid alone on complete resolution of trigger finger's symptoms
时间窗: 1 year postoperatively
Trigger finger's symptoms defined by a clinical Quinnell score ≤1 without the use of an alternative therapy
次要结局
未报告次要终点