MOVE-HIP: Ceramic Hip Resurfacing Versus Total Hip Arthroplasty Using Activity Monitoring
ConditionHip Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDanderyd Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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/m².
Requirement for specialized implants outside routine study procedures.
Trial design
Design model
Parallel
Treatments tested in this trial
Ceramic-on-Ceramic Hip Resurfacing Arthroplasty
Procedure/SurgeryCementless 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.
Contemporary Total Hip Arthroplasty
Procedure/SurgeryContemporary 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.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Ceramic Hip Resurfacing ArthroplastyExperimental treatment 1 intervention
Group B: Total Hip ArthroplastyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean Daily Walking Distance Over the Postoperative Period From 3 to 24 Months
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
3, 12, and 24 months after surgerySecondary outcomes
1
Mean Daily Walking Distance at 24 Months
Mean daily walking distance derived from a standardized 7-day wearable monitoring period at 24 months.
Time frame
24 months after surgery2
Mean Daily Step Count Over the Postoperative Period From 3 to 24 Months
Mean daily step count derived from standardized 7-day wearable monitoring periods at 3, 12, and 24 months.
Time frame
3, 12, and 24 months after surgery3
Forgotten Joint Score-12 (FJS-12) at 24 Months
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 surgery4
Proportion of Participants With FJS-12 Score of 80 or Higher
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 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Danderyd Hospital
Lead sponsor
Karolinska Institutet
Sponsor institution
Karolinska Institutet
Collaborator
Hässleholm Hospital
Collaborator
Ortopediskt Centrum
Collaborator
Source ClinicalTrials.gov