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临床试验/NCT03320291
NCT03320291已完成不适用

Long-term Evaluation of Primary Trapeziectomy and Placement of a RegJoint Implant in the Treatment of Rhizarthrosis

Brugmann University Hospital4 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
4
主要终点
Eroded depth

研究概览

简要总结

In a society based on the use of everyday tools and objects, the loss of function of one or both thumbs due to Rhizarthrosis can drastically reduce the quality of life. Many patients are refractory to preservative treatments.Therefore, multiple arthroplasty techniques were developed.

Trapeziectomy, with or without tendon interposition, gives very good results in terms of pain, function or force. However, it can result in a reduction of the size of the column of the thumb, therefore leading to a loss of force.

Replacement of the trapezo-metacarpal joint with prosthetic material is also proposed and has the advantage to avoid the reduction of the thumb column. Several models are available, mono or bipolar, with a conical or hemispherical cup. Another option is the placement of implants. They were first used when a partial trapeziectomy was possible to counter the collapse of the column and are made of different materials such as metal, silicone, ceramic, pyrocarbon , and gelfoam.

The bioabsorbable poly-LD-lactide implant (PLDLA) is a relatively new possibility for the reconstruction of small joints. Studies have previously revealed that the PLDLA implant is biocompatible and represents a good alternative to arthroplasty by tendon interposition in the reconstruction of the trapezo-metacarpal articulation with osteoarthritis.

In this study, the investigators will investigate the long term effects (1 year after placement) of the Regjoint, a poly-LD-lactide implant (PLDLA).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults> 18 years
  • Patients having had a trapeziectomy for more than one year, because of chronic Rhizarthrosis defined by pain and Radiographic Signs, aka articular pinching, bone erosion and potential subluxation of the trapezo-metacarpal joint.

排除标准

  • Surgery less than 1 year ago.
  • Concomitant pathology of the thumb or wrist (Recent injury or trauma, Quervain tenosynovitis, Carpal tunnel syndrome, Dupuytren, jumping finger).
  • Trapeziectomy secondary to distal prosthesis and scaphoidectomy.

结局指标

主要结局

Eroded depth

时间窗: 1 year post surgery

Evaluation of the bone erosion by means of a radiography (face/profile/oblique). Measure of the degree of subluxation/dislocation.

Maximal amplitude of the articulation

时间窗: 1 year post surgery

Measurement of the angle between the axis of the thumb and the index finger, palmar, with a goniometer

Pain visual assessment scale (EVA scale)

时间窗: 1 year post surgery

Pain evaluation in the thumb column by means of the EVA scale. The EVA scale consists of a 10cm graduated strip. The patient must point its pain level on the strip: 0 cm means 'no pain' (one end of the strip) and 10 cm means 'unbearable pain' (other end of the strip).

Kapandji score

时间窗: 1 year post surgery

Evaluation of the mobility of the thumb carpal-metacarpal joint

Quick-DASH questionnaire

时间窗: 1 year post surgery

Evaluation of the return to daily life activities (work and sport)

Prehension force

时间窗: 1 year post surgery

Measured with a Standard Dynamometer or Hydraulic Pinch Gauge, with the contralateral hand used for comparison.

metacarpus length

时间窗: 1 year post surgery

Computed by radiography

metacarpal space length

时间窗: 1 year post surgery

Computed by radiography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Socorro ORTIZ

Head of clinic

Brugmann University Hospital

研究点 (4)

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