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RECRUITING
NCT04868305
NA

Intramedullary Nail Versus Hip Arthroplasty in Unstable Trochanteric Hip Fractures

Sponsor: Helse Stavanger HF

View on ClinicalTrials.gov

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.

Official title: Randomized Clinical Trial: Treatment of Unstable Trochanteric Hip Fractures With Intramedullary Nail Versus Hip Arthroplasty: Survival, Complications and Postoperative Patient Reported Outcomes

Key Details

Gender

All

Age Range

65 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2021-10-12

Completion Date

2027-03-31

Last Updated

2026-04-30

Healthy Volunteers

No

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

Locations (1)

Stavanger University Hospital

Stavanger, Norway