Danderyd Hospital
Danderyd, 182 88, Sweden
Location status: Recruiting
NCT Number: NCT07839403
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Danderyd, 182 88, Sweden
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: H1 ceramic hip resurfacing
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.
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.
Time frame: 24 months after surgery
Mean daily walking distance derived from a standardized 7-day wearable monitoring period at 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.
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.
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.
Time frame: 24 months after surgery
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interested in participating?
Request InfoDanderyd Hospital
Other
A Pragmatic, Multicenter, Patient-Blinded, Preference-Tolerant Randomized Clinical Trial Comparing Ceramic Hip Resurfacing With Total Hip Arthroplasty Using Activity Monitoring
Acronym: MOVE-HIP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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