MOVE-HIP: Ceramic Hip Resurfacing Versus Total Hip Arthroplasty Using Activity Monitoring (MOVE-HIP)
A Pragmatic, Multicenter, Patient-Blinded, Preference-Tolerant Randomized Clinical Trial Comparing Ceramic Hip Resurfacing With Total Hip Arthroplasty Using Activity Monitoring
MOVE-HIP is a pragmatic, multicenter randomized clinical trial comparing ceramic hip resurfacing arthroplasty with contemporary total hip arthroplasty in adults with symptomatic hip osteoarthritis who are considered clinically eligible for both procedures. Participants in the randomized cohort are allocated 1:1 to either ceramic hip resurfacing or total hip arthroplasty and are kept blinded to treatment allocation where feasible through the 24-month primary follow-up.
The primary objective is to determine whether ceramic hip resurfacing results in greater objectively measured mean daily walking distance over the postoperative period from 3 to 24 months. Activity is assessed during standardized 7-day wearable monitoring periods at 3, 12, and 24 months. The primary estimand is the adjusted overall between-group difference across these postoperative time points. A parallel observational preference cohort may include otherwise eligible patients who decline randomization; this cohort is analyzed separately and does not contribute to the primary randomized inference.
調査の概要
状態
条件
詳細な説明
The trial is designed to test whether a contemporary ceramic-on-ceramic hip resurfacing strategy provides a clinically meaningful advantage over modern total hip arthroplasty in real-world physical activity. Randomization is stratified by study site and sex. All participants undergo baseline assessment including patient-reported outcomes, radiographs, clinical data, and 7-day wearable activity monitoring before surgery.
The randomized cohort includes 220 participants, 110 per treatment group. Follow-up is planned at 3 months, 12 months, 24 months, 5 years, and 10 years. Secondary outcomes include walking distance at 24 months, daily step count, patient-reported outcomes, radiographic outcomes, perioperative outcomes, complications, reoperations, revisions, implant survival, and health-economic outcomes. The study is academically led, and the observational preference cohort follows the same assessment schedule but is analyzed separately.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Olof Sköldenberg, MD, PhD
- 電話番号：+46 8 123 572 45
- メール：olof.skoldenberg@ki.se
研究場所
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Danderyd、スウェーデン、182 88
- 募集
- Danderyd Hospital
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主任研究者：
- Olof Sköldenberg, MD, PhD
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults aged 18 years or older.
- Symptomatic hip osteoarthritis for which primary hip arthroplasty is indicated according to routine clinical practice.
- Considered suitable for both ceramic hip resurfacing arthroplasty and uncemented total hip arthroplasty by the treating surgeon.
- Ability and willingness to comply with study procedures, including patient-reported outcome measures, radiographs, registry linkage, and repeated wearable monitoring.
- Provision of written informed consent.
Exclusion Criteria:
- Anatomical or pathological conditions that clearly preclude hip resurfacing arthroplasty or total hip arthroplasty, including severe deformity requiring non-standard implants or techniques.
- Insufficient femoral head or acetabular bone quality, including large or multiple cysts, advanced femoral head necrosis, severe osteopenia, or osteoporosis where this would contraindicate hip resurfacing arthroplasty.
- Body mass index greater than 40 kg/m^2.
- Requirement for specialized implants outside routine study procedures.
- Medical comorbidity rendering the patient unfit for surgery.
- Cognitive impairment, severe psychiatric disease, alcohol or substance abuse, language barrier, or other reason judged to prevent informed consent or compliance with follow-up.
- Inability to complete patient-reported outcome measures or to participate in wearable monitoring.
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Ceramic Hip Resurfacing Arthroplasty
Participants undergo cementless ceramic-on-ceramic hip resurfacing arthroplasty using the selected study system according to manufacturer instructions, surgeon training requirements, and local surgical routines. |
Cementless ceramic-on-ceramic hip resurfacing arthroplasty. The currently planned study implant is H1, or a subsequent equivalent generation if applicable. Procedures are performed by surgeons with documented arthroplasty experience and system-specific training.
他の名前：
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アクティブコンパレータ：Total Hip Arthroplasty
Participants undergo contemporary standard primary total hip arthroplasty using established implants and bearing combinations according to local routine and individual clinical assessment. Cementless fixation is expected in most cases where clinically appropriate. |
Contemporary standard primary total hip arthroplasty using established implants and bearing combinations according to local routine and individual clinical assessment. Implant choice remains clinically appropriate for the individual participant. |
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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Mean Daily Walking Distance Over the Postoperative Period From 3 to 24 Months
時間枠：3, 12, and 24 months after surgery
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Mean daily walking distance is assessed during standardized 7-day wearable monitoring periods at each postoperative time point. The primary estimand is the adjusted overall between-group difference in mean daily walking distance across 3, 12, and 24 months, with adjustment for preoperative walking distance and prespecified covariates. |
3, 12, and 24 months after surgery
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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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Mean Daily Walking Distance at 24 Months
時間枠：24 months after surgery
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Mean daily walking distance derived from a standardized 7-day wearable monitoring period at 24 months. |
24 months after surgery
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Mean Daily Step Count Over the Postoperative Period From 3 to 24 Months
時間枠：3, 12, and 24 months after surgery
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Mean daily step count derived from standardized 7-day wearable monitoring periods at 3, 12, and 24 months. |
3, 12, and 24 months after surgery
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Forgotten Joint Score-12 (FJS-12) at 24 Months
時間枠：24 months after surgery
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Joint awareness assessed using the Forgotten Joint Score-12 (FJS-12). Scores range from 0 to 100, with higher scores indicating less awareness of the operated joint during everyday activities and a better outcome. |
24 months after surgery
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Proportion of Participants With FJS-12 Score of 80 or Higher
時間枠：24 months after surgery
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Proportion of participants achieving a Forgotten Joint Score-12 (FJS-12) of at least 80. The scale ranges from 0 to 100, with higher scores indicating less awareness of the operated joint during everyday activities and a better outcome. |
24 months after surgery
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Hip Disability and Osteoarthritis Outcome Score (HOOS) Subscales
時間枠：24 months after surgery
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HOOS Pain, Symptoms, Activities of Daily Living, Sport/Recreation, and Quality of Life subscales at 24 months. Each subscale ranges from 0 to 100, with higher scores indicating better status. |
24 months after surgery
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University of California, Los Angeles (UCLA) Activity Score
時間枠：24 months after surgery
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Self-reported habitual physical activity level assessed using the University of California, Los Angeles (UCLA) Activity Score. Scores range from 1 to 10, with higher scores indicating a higher level of physical activity and a better activity-related outcome. |
24 months after surgery
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High-Activity Arthroplasty Score (HAAS)
時間枠：24 months after surgery
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Self-reported functional ability assessed using the High-Activity Arthroplasty Score (HAAS), covering walking, running, stair climbing, and activity level. Total scores range from 0 to 18, with higher scores indicating greater functional ability and a better outcome. |
24 months after surgery
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EuroQol 5-Dimension (EQ-5D-5L Index)
時間枠：24 months after surgery
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Health-related quality of life assessed using the EQ-5D-5L questionnaire. Responses are converted into an index using the Swedish experience-based time trade-off value set (Burström et al., 2020). Index values range from approximately 0.243 to 0.975, with higher values indicating better health-related quality of life. |
24 months after surgery
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EuroQol Visual Analogue Scale (EQ VAS)
時間枠：24 months after surgery
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Self-rated overall health assessed using the EuroQol Visual Analogue Scale (EQ VAS). Scores range from 0 (the worst health imaginable) to 100 (the best health imaginable), with higher scores indicating better perceived health. |
24 months after surgery
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Radiographic Implant and Hip Biomechanics Outcomes
時間枠：24 months after surgery
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Radiographic assessment includes component orientation and fixation, radiolucent lines, migration or loosening, heterotopic ossification, leg length and offset where feasible. In the hip resurfacing group, femoral neck integrity, notching, narrowing, fracture, femoral head movement or crushing, and component alignment are additionally assessed. |
24 months after surgery
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Adverse Events and Postoperative Complications
時間枠：From surgery through 24 months
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Incidence and type of adverse events and complications, including infection, dislocation, periprosthetic fracture, femoral neck fracture, implant fracture, thromboembolic events, nerve injury, wound complications, persistent pain, and other procedure- or implant-related events. |
From surgery through 24 months
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Reoperations and Revisions of the Index Hip
時間枠：From surgery through 24 months
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Number and proportion of participants undergoing reoperation or revision of the index hip, including reason and components exchanged or removed. |
From surgery through 24 months
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Health-Economic Outcomes
時間枠：From surgery through 24 months
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Quality-adjusted life years derived from EQ-5D and incremental cost-effectiveness comparing ceramic hip resurfacing with total hip arthroplasty over 24 months, using available direct and indirect cost data. |
From surgery through 24 months
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Long-Term Implant Survival
時間枠：5 and 10 years after surgery
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Revision-free implant survival assessed using study follow-up and registry data at 5 and 10 years. |
5 and 10 years after surgery
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Olof Sköldenberg, MD, PhD、Danderyd Hospital, Region Stockholm / Karolinska Institutet
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
- MOVE-HIP
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
Undecided as of yet pending IRB approval.
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
米国で製造され、米国から輸出された製品。
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