Prospective Catalystem CT-RSA
2026年7月7日 更新者：Canadian Radiostereometric Analysis Network
Multi-center, Non-controlled, Prospective CT-based Radiostereometric Analysis of Catalystem Primary Hip System
Multi-Centre Study in patients undergoing Total Hip Arthroplasty with the Smith+Nephew CATALYSTEM™ Primary Hip System.
The primary objective is to establish the mean inferior stem migration (subsidence) of the CATALYSTEM™ stem using CT-RSA over the first two postoperative years.
調査の概要
詳細な説明
This study is designed as a prospective, multi-center, non-controlled study of subjects implanted with the CATALYSTEM™ Primary Hip System for primary Total Hip Arthroplasty (THA). Subjects will be enrolled and followed for 2 years post-operatively.
Radiostereometric analysis (RSA) is a tool to measure implant migration, originally developed in the 1970s. It is now well-established that early migration (micromotion) of implants with respect to bone is a predictor for later aseptic loosening. Traditional RSA used dual x-ray to estimate implant migration and has been standardized. CT-based methods (CT-RSA), which do not require metal reference beads have been developed since, and have been validated with equivalent results. International guidelines have since been updated to reflect this move to CT-RSA.
The primary objective is to establish the mean inferior stem migration (subsidence) of the CATALYSTEM™ stem using CT-RSA over the first two postoperative years.
研究の種類
介入
入学 (推定)
30
段階
- 適用できない
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：Sarah Tran
- 電話番号：204-926-1231
- メール：stran@orthoinno.com
研究連絡先のバックアップ
- 名前：Shalini Hari Kumar
- 電話番号：204-926-1232
- メール：skumar@orthoinno.com
研究場所
-
-
Manitoba
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Winnipeg、Manitoba、カナダ、R2K 2M9
- Orthopaedic Innovation Centre
-
主任研究者：
- Thomas Turgeon, MD
-
副調査官：
- Eric Bohm, MD
-
副調査官：
- Colin Burnell, MD
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コンタクト：
- Sarah Tran
- 電話番号：204-926-1231
- メール：stran@orthoinno.com
-
副調査官：
- Pakpoom Ruangsomboon, MD
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副調査官：
- Bryan Flynn, MD
-
副調査官：
- Christopher Graham, MD
-
副調査官：
- Elias Saidy, MD
-
-
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
はい
説明
Inclusion Criteria:
- Patient requires primary unilateral THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital dysplasia.
- Patients is at least 21 years old at the time of informed consent.
- Patient is able to read and comprehend the informed patient consent document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information for study purposes.
- Patient is able and willing to return for follow-up as specified by the study protocol.
- Patient is able and willing to complete the required questionnaires and patient-completed portions of the study protocol.
Exclusion Criteria:
- Patient requires implants other than the planned components or would not be a candidate for allowable components to be used (see 4) in the judgement of the surgeon.
- Patient is planned to have simultaneous bilateral hip arthroplasty
- Patient had contralateral hip arthroplasty less than 6 months prior to the day of surgery.
- Patient is expected to have contralateral hip arthroplasty in the following 6 months at the time of consent into this study.
- Patient has active local or systemic infection.
- Patient has amputations in either leg that would impact rehabilitation following surgery.
- Patient has loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery.
- Patient has poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis, or require additional fixation, or a significant chance of periprosthetic fracture, or the lack of adequate bone to support the implant(s).
- Patient has Charcot's or Paget's disease.
- Patient is pregnant or lactating.
- Patient is bedridden.
- Patient has participated in a clinical investigation with an investigational product (drug or device) in the last 3 months.
- Patient is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- Patients is, in the opinion of the surgeon, a drug or alcohol abuser or has psychological disorder(s) that could affect their ability to complete patient-reported questionnaires or be compliant with follow-up requirements.
- Patient is diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
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
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：CATALYSTEM
CATALYSTEM Hip Replacement System
|
CATALYSTEM セメントレスプライマリー股関節システム（人工股関節全置換術参加者向け）
|
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 |
|---|---|---|
|
Migration - CATALYSTEM Stem
時間枠：2 Years
|
CT-RSA software (V3MA, Leiden, Netherlands) will be used for the analysis of CT images based on extracted 3-dimensional computer models of the Catalystem stem and surrounding bone from the images to represent the respective rigid bodies.
|
2 Years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Subsidence - CATALYSTEM Stem
時間枠：6 months and 1 Year
|
RSA measured subsidence of the CATALYSTEM stem at 6 months and 1 year and to compared to literature values of other stems, using t-test where appropriate.
|
6 months and 1 Year
|
|
Other RSA measurements - CATALYSTEM stem
時間枠：6 Weeks, 6 Months, 1 Year and 2 Years
|
Other RSA measurements of the Emphasys Stem (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points.
These endpoints will be compared to literature values of other stems, using t-test where appropriate.
|
6 Weeks, 6 Months, 1 Year and 2 Years
|
|
Oxford Hip Score
時間枠：Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
|
The Oxford Hip Score (OHS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option.
Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance.
The OHS measures pain and general activities of daily living.
|
Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
|
|
Forgotten Joint Score (FJS-12)
時間枠：6 Weeks, 6 Months, 1 Year and 2 Years
|
Functional and health status will be measured with the Forgotten Joint Score (FJS-12).
The FJS total score range is 0-100, higher scores indicating the patient is able to forget the joint daily lower degree of joint awareness.
|
6 Weeks, 6 Months, 1 Year and 2 Years
|
|
European Quality of Life (EQ-5D-5L)
時間枠：Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
|
EQ5D consists of 5 subscales; Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety / depression.
A health state score is obtained based on the responses from 1-5 in each subscale, from which a single index value is calculated representing patients' overall health state.
EQ5D includes a so called EQ VAS score which is the patients' self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled "the best health you can imagine" and "the worst health you can imagine".
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Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
|
|
Patient Satisfaction (VAS)
時間枠：Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
|
Evaluate and compare the change from preoperative to 2 years between the timepoints in patient-reported Satisfaction as measured using the visual analogue scale (VAS) from 0 (Unsatisfied) - 100 (Completely satisfied)
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Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
|
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Complication
時間枠：Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
|
Evaluate the type and frequency of the complications/adverse events.
|
Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
|
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。
捜査官
- 主任研究者：Thomas Turgeon, MD、University of Manitoba
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 (推定)
2026年8月1日
一次修了 (推定)
2028年12月31日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年7月7日
QC基準を満たした最初の提出物
2026年7月7日
最初の投稿 (実際)
2026年7月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月13日
QC基準を満たした最後の更新が送信されました
2026年7月7日
最終確認日
2026年7月1日
詳しくは
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。