NCT07839403

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
162mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 25, 2026

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2039

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

5.3 years

First QC Date

September 16, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

Hip Resurfacing ArthroplastyTotal Hip ArthroplastyCeramic-on-CeramicPhysical ActivityAccelerometryWearable Activity Monitoring

Outcome Measures

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.

    3, 12, and 24 months after surgery

Secondary Outcomes (14)

  • Mean Daily Walking Distance at 24 Months

    24 months after surgery

  • Mean Daily Step Count Over the Postoperative Period From 3 to 24 Months

    3, 12, and 24 months after surgery

  • Forgotten Joint Score-12 (FJS-12) at 24 Months

    24 months after surgery

  • Proportion of Participants With FJS-12 Score of 80 or Higher

    24 months after surgery

  • Hip Disability and Osteoarthritis Outcome Score (HOOS) Subscales

    24 months after surgery

  • +9 more secondary outcomes

Study Arms (2)

Ceramic Hip Resurfacing Arthroplasty

EXPERIMENTAL

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.

Procedure: Ceramic-on-Ceramic Hip Resurfacing Arthroplasty

Total Hip Arthroplasty

ACTIVE COMPARATOR

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.

Procedure: Contemporary Total Hip Arthroplasty

Interventions

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.

Also known as: H1 ceramic hip resurfacing
Ceramic Hip Resurfacing Arthroplasty

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.

Total Hip Arthroplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danderyd Hospital

Danderyd, 182 88, Sweden

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, HipMotor Activity

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Olof Sköldenberg, MD, PhD

    Danderyd Hospital, Region Stockholm / Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olof Sköldenberg, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant blinding is maintained where feasible until completion of the 24-month primary follow-up. The surgical team is aware of treatment allocation. All participants undergo identical wearable monitoring procedures irrespective of allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm randomized superiority trial. A parallel observational preference cohort may include otherwise eligible patients who decline randomization; the preference cohort is analyzed separately and is not part of the primary randomized comparison.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2026

First Posted

September 24, 2026

Study Start

September 25, 2026

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2039

Last Updated

September 24, 2026

Record last verified: 2026-09

Locations