CMC-1 Replacement Arthroplasty Versus Trapeziectomy
Thumb carpometacarpal (CMC-1) osteoarthritis is a common condition causing pain and disability, particularly among middle-aged and older women. When non-operative treatment fails, surgery is indicated. In Sweden, trapeziectomy (TE), with or without tendon-based adjuncts, is the standard procedure and recommended in the National Care Program introduced in 2022. However, total joint arthroplasty (TJA) has gained popularity because of reports of faster recovery and improved early function, although concerns remain regarding complications, durability, and cost. Comparative studies are therefore needed.
The aim of this study is to compare patient-reported outcomes after dual-mobility TJA versus TE, with or without tendon-based adjuncts, for CMC-1 osteoarthritis using data from the Swedish Hand Surgery Quality Register (HAKIR). To reduce bias in observational data, the study will emulate a hypothetical randomized target trial.
This registry-based cohort study will include adults aged 45 years or older undergoing primary surgery for CMC-1 osteoarthritis. Patients with previous CMC-1 surgery, bilateral procedures, inflammatory joint disease, or extensive missing baseline data will be excluded. Baseline is defined as the date of surgery, and patients will be followed using patient-reported outcome measures collected preoperatively and at 3 and 12 months.
The primary outcome is change in pain on load measured with the HQ-8 questionnaire at 12 months. Secondary outcomes include pain at 3 months, low pain levels at 12 months, other HQ-8 domains, QuickDASH score, patient satisfaction, grip and pinch strength, thumb range of motion, time to reoperation, and postoperative complications.
Potential confounders will be identified using a directed acyclic graph (DAG). Measured confounders include age, sex, surgical centre, calendar year, baseline pain, baseline function, and smoking. Unmeasured factors such as surgeon preference, patient preference, and disease severity not captured in the registry may still cause residual confounding.
Primary analyses will use linear mixed-effects regression to compare adjusted mean pain outcomes between groups at 12 months while accounting for clustering by patient and centre. Secondary outcomes will be analysed using ordinal logistic regression, Cox proportional hazards regression, and logistic regression. Missing data will be handled using multiple imputation, and sensitivity analyses using inverse probability weighting will assess the impact of reoperations and selection bias
調査の概要
状態
研究の種類
入学 (推定)
参加基準
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
adults aged ≥45 years with a diagnosis of CMC-1 osteoarthritis (ICD-10 code M18) who have failed non-operative treatment and are scheduled for primary CMC-1 surgery.
Exclusion Criteria:
- Bilateral CMC-1 surgery or other simultaneous hand interventions
- Previous CMC-1 surgery on the affected hand
- Inflammatory joint disease affecting the hands (e.g., rheumatoid arthritis, systemic lupus erythematosus)
- 30% missing baseline (preoperative) variables
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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Adults diagnosed with and operated for CMC1 OA (ICD-10 M18*)
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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 |
|---|---|---|
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Change from baseline to 12 months in pain on load motion measured with the HAKIR questionnaire.
時間枠：Baseline and 12 months postoperatively
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Pain on load motion assessed using the HQ-8 patient-reported outcome questionnaire.
Responses are reported on an 11-point numerical rating scale ranging from 0 (no symptoms or discomfort) to 100 (worst imaginable symptoms or discomfort) in increments of 10.
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Baseline and 12 months postoperatively
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline to 12 months in pain on unloaded motion measured with the HAKIR questionnaire
時間枠：Baseline and 12 months after surgery
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Pain on unloaded motion assessed using the HQ-8 patient-reported outcome questionnaire.
Responses are reported on an 11-point numerical rating scale ranging from 0 (no symptoms or discomfort) to 100 (worst imaginable symptoms or discomfort) in increments of 10.
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Baseline and 12 months after surgery
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Change from baseline to 12 months in pain at rest measured with the HQ-8 questionnaire
時間枠：Baseline and 12 months postoperatively
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Pain at rest assessed using the HQ-8 patient-reported outcome questionnaire.
Responses are reported on an 11-point numerical rating scale ranging from 0 (no symptoms or discomfort) to 100 (worst imaginable symptoms or discomfort) in increments of 10.
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Baseline and 12 months postoperatively
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Change from baseline to 12 months in stiffness measured with the HQ-8 questionnaire
時間枠：Baseline and 12 months postoperatively
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Stiffness assessed using the HQ-8 patient-reported outcome questionnaire.
Responses are reported on an 11-point numerical rating scale ranging from 0 (no symptoms or discomfort) to 100 (worst imaginable symptoms or discomfort) in increments of 10.
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Baseline and 12 months postoperatively
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Change from baseline to 12 months in weakness measured with the HQ-8 questionnaire
時間枠：Baseline and 12 months postoperatively
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Weakness assessed using the HQ-8 patient-reported outcome questionnaire.
Responses are reported on an 11-point numerical rating scale ranging from 0 (no symptoms or discomfort) to 100 (worst imaginable symptoms or discomfort) in increments of 10.
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Baseline and 12 months postoperatively
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Change from baseline to 12 months in activities of daily living measured with the HQ-8 questionnaire
時間枠：Baseline and 12 months postoperatively
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Activities of daily living assessed using the HQ-8 patient-reported outcome questionnaire.
Responses are reported on an 11-point numerical rating scale ranging from 0 (no symptoms or discomfort) to 100 (worst imaginable symptoms or discomfort) in increments of 10.
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Baseline and 12 months postoperatively
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Change from baseline to 12 months in Quick Disabilities of Arm, Shoulder and Hand Questionnaire (Quick DASH)
時間枠：Baseline and 12 months postoperatively
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Upper extremity disability and symptoms assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
Scores range from 0 to 100, where higher scores indicate greater disability and worse upper extremity function.
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Baseline and 12 months postoperatively
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Change in key pinch strength
時間枠：Baseline and 12 months postoperatively
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kg
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Baseline and 12 months postoperatively
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Change in grip strength
時間枠：Baseline and 12 months postoperatively
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jamar (kg)
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Baseline and 12 months postoperatively
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Change in thumb radial abduction
時間枠：Baseline and 12 months postoperatively
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radial abduction (degrees)
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Baseline and 12 months postoperatively
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Change in thumb plamar abduction
時間枠：From preoperatively to 12 months postoperatively
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palmar abduction (degrees)
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From preoperatively to 12 months postoperatively
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Time to first reoperation* of the index hand
時間枠：primary horizon: 12 months; secondary: maximum available follow-up
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primary horizon: 12 months; secondary: maximum available follow-up
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Risk of any (non-reoperation) complication within 12 months
時間枠：within 12 months after surgery
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occurrence of any registered postoperative complication of the index hand recorded in HAKIR
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within 12 months after surgery
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- HAKIRcmc1
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?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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