RecruitingNot ApplicableNCT04868305

Intramedullary Nail Versus Hip Arthroplasty in Unstable Trochanteric Hip Fractures

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


Sponsor

Helse Stavanger HF

Enrollment

170 participants

Start Date

Oct 12, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 YearsMax Age: 120 Years

Inclusion Criteria5

  • 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

Exclusion Criteria3

  • Previous hip surgery on ipsilateral or contralateral side
  • Non-ambulant preinjury
  • Patient not living in the area of hospital care

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Interventions

PROCEDUREIntramedullary nail

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

PROCEDUREHip 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

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NCT04868305


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