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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Olof Sköldenberg, MD, PhD
- Numéro de téléphone: +46 8 123 572 45
- E-mail: olof.skoldenberg@ki.se
Lieux d'étude
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Danderyd, Suède, 182 88
- Recrutement
- Danderyd Hospital
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Chercheur principal:
- Olof Sköldenberg, MD, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean Daily Walking Distance Over the Postoperative Period From 3 to 24 Months
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean Daily Walking Distance at 24 Months
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Olof Sköldenberg, MD, PhD, Danderyd Hospital, Region Stockholm / Karolinska Institutet
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MOVE-HIP
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Undecided as of yet pending IRB approval.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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