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临床试验/NCT01921621
NCT01921621已完成不适用

The Copernicus Initiative - The Study of Proficiency Based Training in Arthroscopic Surgery

Arthroscopy Association of North America1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
score on a validated assessment tool using a videotaped performance of an arthroscopic Bankart repair

研究概览

简要总结

This study examines in a prospective, randomized and blinded study design the impact of a proficiency based training methodology on the acquisition of arthroscopic surgical skills employing both a dry shoulder simulator model, and cadaver specimens for the demonstration of surgical skill proficiency.

详细描述

Background: Simulation-based skills training has been proposed as a method of augmenting traditional in vivo training of surgeons.[1] Simulation based training is still in its infancy and there is considerable variability in the United States and around the world on how this type of training is configured.[2] The first successful simulation validation study used a proficiency-based progression methodology.[3] Trainees were required to demonstrate a performance benchmark (based on experienced surgeons performance on a simulator) before completing a laparoscopic cholecystectomy in vivo.[4] This approach has not been used in arthroscopy. In this study we propose to evaluate the utility of proficiency based skills training for learning how to perform an arthroscopic Bankart repair for unidirectional anterior shoulder instability.

Proficiency will be determined using metric based performance levels of surgeons very experienced in performing an arthroscopic Bankart procedure.[5] Metrics have previously been identified, operationally defined and agreed upon at an Arthroscopy Association of North America Delphi panel meeting and then validated. Metrics which have demonstrated construct validity will be used to define a performance benchmark/level of proficiency. Group C will be required to train on a simulator model until they demonstrate this predetermined performance level. At the completion of training all trainees are required to complete a Bankart procedure on a fresh cadaver shoulder specimen. Operative performance will be video recorded and subsequently assessed by two experienced arthroscopic surgeons blinded to subject identity and group. Raters will have been trained to reliably identify predefined procedural steps, errors and sentinel errors to an inter-rater reliability level of r >0.8. [6]

Hypothesis: It is hypothesized that proficiency based progression trainees will perform an arthroscopic Bankart procedure significantly better on a fresh cadaver shoulder than traditionally trained subjects. They will also perform significantly better than trainees who received the exact same curricular material,including the use of a simulator, but will be allowed to progress at their own desired pace with no requirement to demonstrate performance of skills to a proficiency benchmark before progressing in training.

Procedure: Three groups of orthopaedic surgical trainees in postgraduate years four and five will be provided online access to orientation videos demonstrating how to perform a standard arthroscopic Bankart repair. A set of baseline assessments of all 3 groups will be obtained prior to the beginning of training and include visuospatial,[7] perceptual,[8,9] and psychomotor evaluations[10-13] to ensure that the groups are comparable. The standard training group (Group A) will then progress with the training as they would today during a routine resident course. Groups B and C will be prospectively randomized (using an online randomizer) to their respective training conditions. Group C will study the online didactic information until they have demonstrated a predefined proficiency criterion. In addition, successful completion and proficiency demonstration with arthroscopic knot tying will be a requirement for them to proceed to the simulation based training models. The benchmark has been established using knots tied by an experienced group of arthroscopic surgeons. On the simulation models they will continue training until proficiency has been demonstrated. Group C trainees will be supervised and given formative feedback on their performance by an experienced trainer and assessor during these skills training sessions. Group B will complete the same curriculum as Group C with the exception that they will be free to progress through training at their own desired pace with no requirement to demonstrate proficiency in any phase of the training.

Outcome assessment On completion of the course proper all three groups of trainees will be required to complete a Bankart procedure on a fresh cadaver specimen. They will be assisted by an experienced orthopaedic surgeon blinded to the subjects training group and instructed to assist ONLY at the direction of the study participant. No guidance will be provided. Their performance will be video recorded for subsequent analysis. Video raters will be experienced orthopaedic surgeons who will be blinded as to subjects' identity and group. Objective assessment of their intra-operative performance will be measured using the pre-defined performance metrics agreed upon by the Arthroscopy Association of North America Delphi panel and previously demonstrated to show construct validity. These will include correct steps of the procedure completed, time to complete the procedure, intra-procedure errors and sentinel errors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •4th and 5th year Orthopedic Residents

排除标准

  • 未提供

研究组 & 干预措施

Group A

No Intervention

Control: Group of Orthopedic Residents who receive arthroscopic surgery training at the Orthopedic Learning Center during a standard week-end Resident Arthroscopic Training Course

Group B - Simulation Training

Active Comparator

Group B resident training includes the use of a dry model shoulder simulator for practicing the steps and avoiding the errors of an arthroscopic Bankart repair

干预措施: Group B - Simulation Training (Behavioral)

Group C - Proficiency Based Progression

Experimental

Group C - Proficiency Based Progression Group C residents must test to proficiency on the cognitive material contained in the orientation video, demonstrate arthroscopic knot tying proficiency to a pre-determined benchmark, and perform an arthroscopic Bankart repair on a dry shoulder simulator model to a pre-determined benchmark in order to progress in the training exercise

干预措施: Group C - Proficiency Based Progression (Behavioral)

结局指标

主要结局

score on a validated assessment tool using a videotaped performance of an arthroscopic Bankart repair

时间窗: 9 months

validated metrics for a reference arthroscopic Bankart repair include 45 steps and 77 potential errors of which 20 are "sentinel errors" (either the error could potentially lead to a significant compromise of the success of the procedure, or introduces significant iatrogenic damage).

次要结局

  • time to complete an arthroscopic Bankart repair on a cadaver specimen(6 months)

研究者

发起方
Arthroscopy Association of North America
申办方类型
Other
责任方
Sponsor

研究点 (1)

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