NCT06152198 Functional Outcome After ORIF or Arthroplasty for Femoral Neck Fracture
| NCT ID | NCT06152198 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University |
| Condition | Hip Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 340 participants |
| Start Date | 2021-06-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 340 participants in total. It began in 2021-06-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Aim To investigate the effect of internal fixation versus hip arthroplasty on physical function and pain in elderly patients. Methods This is a substudy of an on-going nationwide multicenter registry-based RCT named HipSTHeR- (Hip Screws or Total Hip replacement or undisplaced femoral neck fracture in elderly patients) \[21\]. The aim is to recruit 340 patients with undisplaced or minimally displaced femoral neck fracture, Garden 1 or 2, are randomized to surgery either with internal screw fixation or hip arthroplasty. This substudy aims to investigate the potential differences between internal fixation versus hip arthroplasty regarding physical function and pain 4- and 12- months after surgery. Those included in the main study will be contacted by letter a few weeks after the surgery to be invited to participate in a further study. The assessor will then contact the person by telephone to answer further questions and to obtain informed consent. The follow-ups will be conducted over telephone and mail at 4 and 12 months. During the follow-up the participants will answer questions about their functional level. Information on randomisation and fracture data will be acquired from the Swedish Fracture Register and treatment data from the Swedish Hip Arthroplasty Register. Primary outcome The New Mobility Score will be used as the primary outcome with follow-up at 4- and 12 months. Secondary outcome WOMAC will be used as an additional hip specific patient reported outcome. Activities of daily living will be assessed with Katz ADL index to evaluate the patients' performance and the need of assistance in ADL. Patients' cognitive status will be assessed ALFI-MMSE, adapted from Adult Lifestyles and Function Interview (ALFI-MMSE). The Geriatric Depression Scale (GDS-15), which are developed to identify depressive symptoms. The Philadelphia Geriatric Center Morale Scale (PGCMS) and have been used in several studies including frail people living in residential care facilities and can be used among patients with cognitive impairment.
Eligibility Criteria
Inclusion Criteria: * Undisplaced (Garden I-II) femoral neck fracture (within 72h) * Treated at participating unit * Informed consent * Amenable for both treatment options * Included in the Hipsther trial Exclusion Criteria: * No informed consent * Pathological or stress fracture * Peri-implant fracture * Previous inclusion of a contralateral Garden 1 or 2 femoral neck fracture
Contact & Investigator
Olof Wolf, MD, PhD
PRINCIPAL INVESTIGATOR
Uppsala University
Frequently Asked Questions
Who can join the NCT06152198 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Hip Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06152198 currently recruiting?
Yes, NCT06152198 is actively recruiting participants. Contact the research team at erika.olofsson@umu.se for enrollment information.
Where is the NCT06152198 trial being conducted?
This trial is being conducted at Uppsala, Sweden.
Who is sponsoring the NCT06152198 clinical trial?
NCT06152198 is sponsored by Uppsala University. The principal investigator is Olof Wolf, MD, PhD at Uppsala University. The trial plans to enroll 340 participants.