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临床试验/NCT05464459
NCT05464459进行中(未招募)不适用

A Prospective Case Series to Evaluate the Outcomes and Acceptability of a Novel Surgical Technique of Pyrocarbon Interposition Arthroplasty of the Elbow, in Young Patients With Severe Arthritis.

Wrightington, Wigan and Leigh NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2022年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
8
试验地点
2
主要终点
Safety and acceptability

研究概览

简要总结

The current study will be a prospective observational study (or collective case study in a small, carefully selected cohort of consenting patients with advanced arthritis. This study would be classified as a stage I study according the IDEAL framework for surgical innovation

详细描述

Osteoarthritis (OA) of the elbow is associated with pain and loss of motion, which can have a dramatic impact on overall upper limb function due to the inability to position the hand to carry out activities of daily living. OA is characterised by osteophyte formation of the olecranon, coronoid and olecranon fossae, whilst the ulnohumeral and radiohumeral joint spaces may be relatively well preserved. The osteophytes cause terminal extension and flexion pain and impingement, whilst the limited arc of movement is often relatively pain-free. Loose bodies are also commonly present and can cause mechanical locking. Pain throughout the limited range of movement however, indicates joint destruction. This can be confirmed radiographically, which in contrast to the typical OA presentation described above, shows articular cartilage loss with narrowing or obliteration of the entire joint space, not usually seen in primary osteoarthritis. The pathologies in which loss of joint space is more commonly seen are post-septic arthritis, post-traumatic arthritis and inflammatory arthritis.

Total elbow arthroplasty (TEA) is thought to be an effective treatment for a range of pathologies including rheumatoid arthritis, late stage primary osteoarthritis, acute fracture and post-traumatic arthritis. However, it has been reported in the literature that younger patients undergoing TEA may experience earlier failure of the implant and higher complication rates. This is thought to be linked to higher functional demands placed on the implant due to greater occupational loading or participation in more demanding leisure activities. For this reason, other viable alternative to TEA are being sought by surgeons for younger patients with high functional demands.

Interposition arthroplasty has been proposed as an alternative to TEA for younger patients in the literature with various surgical techniques described. According to Thomas, the basic principle of interposition arthroplasty of the elbow is to perform a resection of the opposing bone ends and place something in between the distal humerus and the olecranon, which will then theoretically allow movement to occur without painful grinding of the joint.

Two of the major risks of TEA are aseptic loosening and periprosthetic infection. In the event of a significant joint infection, revision of the TEA procedure is often necessary and may be performed as a two-stage operation. Initially the prosthesis is removed and the infection is treated, a process that often involves the use of an antibiotic-impregnated spacer and oral antibiotics. If appropriate, once the infection is eradicated, a new prosthesis will be implanted. Cases have however been documented in the literature where the patients in receipt of spherical antibiotic cement spacers are satisfied with the movement and pain relief provided by the spacer, and subsequently decline re-implantation of a second prosthesis and. This has led the current author to question whether interposition arthroplasty using a spherical joint spacer may be a viable alternative to TEA in young patients with higher functional demands in whom there is a greater risk of premature aseptic loosening after TEA.

Pyrocarbon interposition implants have been successfully used in the small joints of the hand, wrist and foot, and more recently their use has been trialed in the shoulder with acceptable outcomes . Pyrocarbon is deemed an ideal material for the manufacture of orthopaedic implants due to its strength, resistance to wear and resistance to fatigue. It is also stated in the literature that there have been no reports of periarticular infiltration or reaction to pyrocarbon particles transmitted by the blood or lymphatic systems into organs such as the brain, kidneys or liver.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Medically fit for surgery
  • Advanced osteoarthritis, post-traumatic arthritis, or post-septic arthritis
  • Severe inflammatory arthritis without severe bone destruction - Larsen grade III or less
  • Failed conservative treatment
  • Unsuitable for TEA due to high functional demands

排除标准

  • Severe inflammatory arthritis with severe bone destruction
  • Arthritis suitable for treatment with arthroscopic debridement.

结局指标

主要结局

Safety and acceptability

时间窗: 24 months

The principal research objective is to assess the safety and acceptability of interposition arthroplasty of the elbow using a spherical pyrocarbon implant in a prospective consecutive case series of carefully selected patients.

次要结局

  • Motion Analysis(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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