Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Success of the intervention at 3 months
研究概览
简要总结
Digital osteoarthritis is the second localization of symptomatic osteoarthritis, after the knee. Its cardinal symptoms are particularly intense pain and functional impairment in the case of the erosive form. There is currently no etiological treatment for osteoarthritis. Symptomatic treatments have a modest efficacy, which justifies the search for new treatments. The surgical options are arthrodesis or prosthesis, invasive techniques potentially sources of complications, and finally proposed infrequently given the prevalence of digital osteoarthritis.
DECAD is a prospective phase II trial aimed at evaluating the efficacy of surgical joint denervation in painful digital osteoarthritis.
详细描述
Osteoarthritis is the most common joint pathology of the musculoskeletal system. It affects 6 million French people and constitutes a public health problem. Osteoarthritis of the hands or digitalis is the second localization of symptomatic osteoarthritis, after the knee. Its main risk factors are female sex, age, genetic factors, and obesity.
Osteoarthritis combines articular cartilage degradation, synovial inflammation, subchondral bone remodeling and osteophyte development. Its cardinal symptoms are pain and functional impairment (at a level sometimes close to inflammatory rheumatism such as rheumatoid arthritis), particularly intense in the case of the erosive form. There is also local joint inflammation associated with pain. Pain in osteoarthritis is a complex phenomenon involving joint tissues other than cartilage, a tissue that is not innervated (subchondral bone, joint capsule, synovial membrane).
There is currently no etiological treatment for osteoarthritis. Symptomatic treatments have a modest efficacy, which justifies the search for new treatments. The surgical options are arthrodesis or prosthesis, invasive techniques potentially sources of complications, and finally proposed infrequently given the prevalence of digital osteoarthritis.
The only current conservative surgical solution that can be proposed for intractable painful proximal interphalangeal joint (PIPJ) osteoarthritis is denervation. This technique consists of cutting the nerve branches intended for the PIPJ in order to directly interrupt the pain pathways. It reduces pain by 80% after 5 years, without loss of mobility. There are only 4 published series reporting the results of this technique (2-3). These were retrospective case series with a low level of evidence. The patient satisfaction rate reached 90%, with transient paresthesias as the only reported complication. The mechanism of action for the effectiveness of this intervention has never been studied.
Our hypothesis is that denervation of the PIP has clinical efficacy in painful digital osteoarthritis refractory to usual treatments, and that it would have a structural effect that can be objectified on MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age ≥ 18 years
- •Patients with symptomatic digital osteoarthritis according to the criteria of the American College of Rheumatology
- •1 painful PIP joint (Analog digital scale ≥ 4/10) for more than 3 months
- •having failed the usual medical treatment for a minimum of 3 months (level 1 analgesics, NSAIDs, infiltrations)
- •Signature of informed consent
- •patient affiliated to a social security scheme
- •knowing how to read French (for the questionnaires)
排除标准
- •digital osteoarthritis secondary to other known causes (eg gout, reactive arthritis, RA, psoriatic arthritis, spondyloarthropathies, septic arthritis)
- •anesthetic contraindications to surgery or to performing an MRI
- •Existence of a pain syndrome in the upper limbs, which would interfere with the assessment of AD.
- •Fibromyalgia
- •Use of oral, intramuscular or intra-articular or intravenous corticosteroids, immunosuppressants (methotrexate, sulfasalazine, leflunomide, biomedicines), hyaluronic acid infiltration in the finger joints in the previous month
- •Introduction of a new treatment for osteoarthritis of the hand in the previous month, including physiotherapy and fitting of a new finger orthosis.
- •History of denervation of the proximal interphalangeal joint (PIP)
- •Patient under legal protection (guardianship or curatorship) and patient deprived of liberty
- •Patient under AME
- •Participation in another interventional research involving the human person or period of exclusion at the end of a previous research involving the human person.
结局指标
主要结局
Success of the intervention at 3 months
时间窗: 3 months
Success of the intervention at 3 months, defined by a reduction in pain of at least 2 points compared to the measurement at inclusion, with the numerical painscale (from 0 to 10) for the operate finger
次要结局
- Grip strength at 6 months(6 months)
- Pain at 6 months(6 months)
- Quality of life at 6 months : Score quick-DASH(6 months)
- Quality of life at 6 months : Score AUSCAN(6 months)
- PGI-C Score at 6 months(6 months)