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Intramedullary Nail Versus Hip Arthroplasty in Unstable Trochanteric Hip Fractures

NCT04868305 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-04-30

No results posted yet for this study

Summary

A hip fracture is a large burden to the patient with increased mortality, pain and increased need for daily assistance. Trochanteric fractures of the femur (FTF) represents about 35% of the hip fractures. Today FTFs are mainly treated with internal fixation using sliding hips screws (SHS) or intramedullary nail (IMN), whilst hip arthroplasty (THA/HA) is rarely used. Despite advances in the design of the internal fixation implants there is a high failure rate, in particular in cases of FTFs classified as unstable fractures. Since the introduction of hip arthroplasty in femoral neck fractures there has been a reduction in complication rates, early mobilization and shorter hospital stays.

The primary objective of this project is to investigate if treatment with hip arthroplasty in unstable FTFs will increase the postoperative mobility, give a better general health outcome for the patient, better quality of life and reduce re-operation rate for the patients compared to those operated with the traditional IMN.

Conditions

  • Hip Injuries and Disorders
  • Hip Fractures

Interventions

PROCEDURE

Intramedullary nail

Intertan nail (Smith \& Nephew)\* or Gamma 3 nail (Stryker)\* \* All of the above-mentioned products are subjects to change into an equivalent product

PROCEDURE

Hip arthroplasty

Total hip arthroplasty: * Cemented: Lubinus (Link)\*, Exeter (Stryker)\* * Uncemented: Restoration Modular (Stryker)\* * Cup: Cemented Avantage dual mobility cup (Zimmer Biomet)\* Hemiarthroplasty: * Cemented: Lubinus (Link)\*, Exeter (Stryker)\* * Uncemented: Restoration Modular (Stryker)\* * All of the above-mentioned products are subjects to change into an equivalent product

Sponsors & Collaborators

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Ane Djuv, MD., PhD · Helse Stavanger HF

  • Jan-Erik Gjertsen, MD., PhD · Haukeland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04868305 on ClinicalTrials.gov