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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 120
Healthy Volunteers: f
View:

• Age ≥ 65 years

• American Society of Anesthesiology Score (ASA) \< 4

• Ambulant with or without aid (preinjury)

• Radiological verified unstable trochanteric hip fracture (AO 31A2.2 - 3.3)

• Written consent obtained by patient or his/her next of kin

Locations
Other Locations
Norway
Stavanger University Hospital
RECRUITING
Stavanger
Contact Information
Primary
Thomas Abel Woldeyesus, MD
thomas.abel.woldeyesus@sus.no
+4751513488
Backup
Ane Djuv, MD., PhD
ane.djuv@sus.no
+4751518284
Time Frame
Start Date: 2021-10-12
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 170
Treatments
Active_comparator: Intramedullary nail
Intramedullary nail with proximal lagscrew and distal locking screw(s)
Active_comparator: Hip arthroplasty
Hemiarthroplasty (HA) or Total hip arthroplasty (THA). A cemented dual-mobility cup will be utilized in THA. Addition of cerclage/trochanter claw plate to fixate trochanter major will be used when suitable.
Related Therapeutic Areas
Sponsors
Leads: Helse Stavanger HF

This content was sourced from clinicaltrials.gov