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A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure

2026年8月27日更新者：DePuy Synthes Products, Inc.

VIRTUGUIDE™ SYSTEM REGISTRY

The purpose of this study is to assess the surgeon experience and surgery outcomes in participants undergoing index Lapidus procedure for the correction of hallux valgus (a foot deformity where the big toe angles outward towards the other toes, causing a painful bony bump at the base of the big toe joint) using the VIRTUGUIDE System and compatible DePuy Synthes Lapidus implants.

調査の概要

状態

募集

条件

外反母趾

研究の種類

観察的

入学 (推定)

100

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Marcie Maichle
電話番号：443-987-0665
メール：MMaichle@ITS.JNJ.com

研究連絡先のバックアップ

名前：Priyamvada Devineni
メール：pdevinen@its.jnj.com

研究場所

アメリカ
- Virginia
  - Virginia Beach、Virginia、アメリカ、23462
    - 募集
    - Atlantic Orthopaedic Specialists

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

大人
高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

The study population will include adults who will undergo surgical treatment for the correction of hallux valgus via Lapidus procedure using the VIRTUGUIDE System and will receive a compatible DePuy Synthes Lapidus implant.

説明

Inclusion criteria:

Participants, both male and female, >= 22 years old at the time of consent
Participants undergoing a primary Lapidus procedure for the correction of hallux valgus using the VIRTUGUIDE System (software + instruments) and who receive a compatible DePuy Synthes Lapidus implant
Participants must be able to read and understand questions and responses in an available translated language for patient reported outcomes (PROMs)
All primary Lapidus fixation implants are used on-label according to the implant IFU/FDA cleared labeling
Participants who can speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and are willing and able to provide informed patient consent for participation and have authorized the transfer of his/her information to DePuy Synthes

Exclusion criteria:

Participation in any other medical device or medicinal product study within the previous month. Participation in observational studies is allowed
In the opinion of the Principal Investigator, the subject is unable to comply with the requirements of the registry
Participant has known allergies to implant components
Participant presenting for a revision of a Lapidus procedure
Participant has existing hardware in the operative joint

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
VIRTUGUIDE System and Compatible DePuy Synthes Lapidus Implant(s) Participants with hallux valgus undergoing index Lapidus procedure using the VIRTUGUIDE System and compatible DePuy Synthes Lapidus implant(s) will be enrolled in the study. All participants will be followed up as per the surgeon's standard of care for up to 12 months after the surgery.

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Radiographic Documentation of Fusion/Healing Status 時間枠：Up to 12 months post-procedure	Evaluation of healing, that is, healing will be a combination of radiographic and clinical assessment. Healing (fusion) will be considered achieved based on surgeon interpretation of radiographic images, lack of clinical motion and no pain at the fused site indicative of failed fusion. Imaging, whether X-ray or computed tomography (CT) collected per standard of care (SOC), utilized for radiographic assessment will be collected.	Up to 12 months post-procedure
Patient Reported Outcome Measures (PROM): Manchester Oxford Foot Questionnaire (Quality of Life Index) Scores 時間枠：Up to 12 months post-procedure	The Manchester Oxford Foot Questionnaire (MOxFQ) with three domains (walking/standing, pain, and social interaction) is a standardized instrument developed and validated specifically for hallux valgus (bunions) corrective surgery. It is widely regarded as the gold standard for content and construct validity. It is designed for self (participant) completion and consists of sixteen (16) questions all of which are scored on a five (5) item Likert scale. The scores for each domain range from 0-100, with 100 representing the worst condition.	Up to 12 months post-procedure
PROM: Numeric Pain Rating Scale Scores 時間枠：Up to 12 months post-procedure	The Numeric Pain Rating Scale is a three (3) question self-administered PROM with a 10-point one-dimensional line anchored on either end by verbal descriptors ranging from "no pain" to "worst imaginable pain". The higher score indicates greater pain intensity. The three questions ask the participant to indicate the intensity of current, best, and worst pain levels over the past 24 hours.	Up to 12 months post-procedure
Number of Participants Reporting any Perioperative Adverse Event (AE) 時間枠：Up to 12 months post-procedure	An AE is any untoward medical occurrence (sign, symptom, or disease) in a participant that is deemed at least possibly related to the DePuy Synthes registry device, or any adjunctive implant device used during the index procedure.	Up to 12 months post-procedure
Number of Participants with AEs Related to Device/Procedure 時間枠：Up to 12 months post-procedure	An AE is any untoward medical occurrence (sign, symptom, or disease) in a participant that is deemed at least possibly related to the DePuy Synthes registry device, or any adjunctive implant device used during the index procedure. The determination of whether the AE is related to the device and/or procedure will be based upon whether a causal relationship between the device and/or procedure and the AE is at least a reasonable possibility, i.e., the relationship cannot be ruled out. A causal relationship cannot be ruled out if, in the medical judgment of the Investigator, the effect follows a reasonable temporal association with the use of the device and/or is confirmed by the improvement of the effect upon discontinuation of the clinical use of the device, and/or the effect is not reasonably explained by the participant's clinical state.	Up to 12 months post-procedure
Number of Participants with Serious Adverse Events (SAEs) 時間枠：Up to 12 months post-procedure	SAEs are AEs defined as having one or more of the following outcomes: death, serious deterioration in the health of the subject that has resulted in a. life-threatening illness or injury b. permanent impairment of a body structure or a body function c. hospitalization or prolongation of existing hospitalization d. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function e. chronic disease and Fetal distress, fetal death or a congenital physical or mental impairment or birth defect.	Up to 12 months post-procedure
Number of Participants Reporting Device Deficiency 時間枠：Up to 12 months post-procedure	Device deficiencies include malfunctions, use errors, and inadequate labeling. Device malfunctions are failures of the device to perform as intended and can be defined as issues with software (VIRTUGUIDE Pre-Planning Software), any breakage, malposition, migration, and/or loosening of the device.	Up to 12 months post-procedure
Number of Participants who Underwent Revision 時間枠：Up to 12 months post-procedure	Revision is defined as surgery following the index Lapidus procedure that involves adjustment, modification, removal, or replacement of the implanted device. Surgeries involving adjunctive implants at the first metatarsal-cuneiform joint are considered as a revision.	Up to 12 months post-procedure
Number of Participants who Underwent Reoperation 時間枠：Up to 12 months post-procedure	Reoperation is defined as any subsequent surgical procedure performed following the index surgery that does not involve adjustment, modification, removal, or replacement of the primary Lapidus implant(s), nor the addition of adjunctive fixation at the first metatarsal-cuneiform joint.	Up to 12 months post-procedure
Number of Participants Reporting Recurrence 時間枠：Up to 12 months post-procedure	Radiographic recurrence will be considered to have occurred in those subjects with correction if both of the following criteria are met: Intermetatarsal Angle (IMA) of greater than (>)12 degree and Hallux Valgus Angle (HVA) > 15 degree.	Up to 12 months post-procedure

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

DePuy Synthes Products, Inc.

捜査官

スタディディレクター：DePuy Synthes Products, Inc. Clinical Trial、DePuy Synthes Products, Inc.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月7日

一次修了 (推定)

2028年5月15日

研究の完了 (推定)

2028年5月15日

試験登録日

最初に提出

2026年4月28日

QC基準を満たした最初の提出物

2026年4月28日

最初の投稿 (実際)

2026年5月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月28日

QC基準を満たした最後の更新が送信されました

2026年8月27日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

DST202501 (その他の識別子：DePuy Synthes Products, Inc.)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。