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临床试验/NCT05267964
NCT05267964Unknown不适用

Trapeziometacarpal Prosthesis vs. Resection-Interposition Arthroplasty A Randomized Controlled Trial

Medical University of Graz0 个研究点目标入组 100 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Functional outcome - Thumb retropulsion

研究概览

简要总结

Rhizarthrosis is a frequently occurring pathology leading to severe limitations in daily life due to pain and loss of function. Good clinical results have been reported for some carpometacarpal (CMC) joint prosthesis designs, but high failure rates due to loosening and dislocation must be considered. The study aim was to investigate a new, double mobility CMC-prosthesis design with special focus on (1) the functional outcome and (2) patient quality of life (QOL)

详细描述

The Epping resection-suspension arthroplasty procedure was described in 1983 to address the proximal migration of the first ray while providing pain free grip strength without any implants. It has shown rather good functional outcome and pain relief. A reduction in thumb opposition strength of 27% compared to the contralateral side and intermittent pain in physical activity is reported, however. Further, studies comparing trapeziectomy and trapeziectomy with tendon interposition recommend trapeziectomy due to the simple technique and comparable outcome.

Endoprosthesis of the first carpometacarpal (CMC) joint represents a different treatment strategy aiming at an exact reconstruction of the joint geometry. Some studies report excellent functional outcome and pain relief. However, there are some prosthesis designs (cemented and uncemented) with high rates of loosening, luxation and poor subjective results. To address these issues, a prosthesis was designed combining a cylindric, double mobility cup and a hydroxyapatite covered stem and cup available in different sizes. The aim of this study was to compare this new prosthesis design to the Epping arthroplasty as the current standard in the investigator's institution regarding (1) the functional outcome with special focus on mobility and strength and (2) patient quality of life (QOL) and pain relief.

Note: The registration of this trial on Clinicaltrials.gov was carried out retrospectively after primary completion of the study.

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
Double (Participant, Investigator)

盲法说明

Patients are radomized into two groups prior to the surgical intervention using the radomizing programm of the medical university of graz.

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

  • symptomatic rhizarthrosis grade 2 and 3 according to Eaton's classification,
  • failed conservative treatment prior to surgery,
  • written informed consent to the study.

排除标准

  • scaphotrapezotrapezoidal (STT) arthrosis,
  • former CMC joint surgery,
  • patients under custodianship.

结局指标

主要结局

Functional outcome - Thumb retropulsion

时间窗: twelve months postoperative

Measurement of thumb retropulsion (scale from 1 to 3) range according to Kapandji

Functional outcome - maximal palmar abduction

时间窗: twelve months postoperative

measurement of the maximal palmar abduction using a goniometer.

Functional outcome - maximal radial abduction

时间窗: twelve months postoperative

measurement of the maximal radial abduction using a goniometer.

Functional outcome - tip-to-tip force

时间窗: twelve months postoperative

The tip-to-tip force (between thumb and index finger) was measured in Newton (N) using a handheld dynamometer (Cit Technics, Haren, Netherlands).

Functional outcome- Thumb opposition

时间窗: twelve months postoperative

Measurement of thumb opposition (scale from 1 to 10) range according to Kapandji. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.

次要结局

未报告次要终点

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

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