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.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
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.
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Olof Sköldenberg, MD, PhD
- Phone Number: +46 8 123 572 45
- Email: olof.skoldenberg@ki.se
Study Locations
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-
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Danderyd, Sweden, 182 88
- Recruiting
- Danderyd Hospital
-
Principal Investigator:
- Olof Sköldenberg, MD, PhD
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: 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.
Other Names:
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Active Comparator: 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. |
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Daily Walking Distance Over the Postoperative Period From 3 to 24 Months
Time Frame: 3, 12, and 24 months after surgery
|
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
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Daily Walking Distance at 24 Months
Time Frame: 24 months after surgery
|
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
Time Frame: 3, 12, and 24 months after surgery
|
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
|
|
Forgotten Joint Score-12 (FJS-12) at 24 Months
Time Frame: 24 months after surgery
|
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
|
|
Proportion of Participants With FJS-12 Score of 80 or Higher
Time Frame: 24 months after surgery
|
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
Time Frame: 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
Time Frame: 24 months after surgery
|
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)
Time Frame: 24 months after surgery
|
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)
Time Frame: 24 months after surgery
|
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)
Time Frame: 24 months after surgery
|
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
|
|
Radiographic Implant and Hip Biomechanics Outcomes
Time Frame: 24 months after surgery
|
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
|
|
Adverse Events and Postoperative Complications
Time Frame: From surgery through 24 months
|
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
Time Frame: From surgery through 24 months
|
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
Time Frame: From surgery through 24 months
|
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
Time Frame: 5 and 10 years after surgery
|
Revision-free implant survival assessed using study follow-up and registry data at 5 and 10 years. |
5 and 10 years after surgery
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Olof Sköldenberg, MD, PhD, Danderyd Hospital, Region Stockholm / Karolinska Institutet
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- MOVE-HIP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Undecided as of yet pending IRB approval.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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