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Clinical Trials/NCT04900506
NCT04900506
Active, not recruiting
Not Applicable

Cemented Hemiarthroplasty in Femoral Neck Fractures; Are Clinical Results Affected by Surgical Approach. A Randomized Clinical Trial Comparing Posterior and Anterior Approach

Sorlandet Hospital HF2 sites in 1 country210 target enrollmentJanuary 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Femoral Neck Fractures
Sponsor
Sorlandet Hospital HF
Enrollment
210
Locations
2
Primary Endpoint
Harris Hip Score
Status
Active, not recruiting
Last Updated
11 months ago

Overview

Brief Summary

Dislocated femoral neck fractures are routinely treated with cemented hemiartroplasty and the direct lateral approach (Hardinge) has commonly been used in Norway. The investigators have lately witnessed a significant change in the prefered surgical approaches in total hip arthroplasty (THA) in favor of the posterior and anterior approaches. The direct lateral approach has in THA, more or less, been abandoned in Norway. Numerous studies have reported superior results using the posterior and anterior approahes compared to the lateral approach.

Detailed Description

The investigators have witnessed a marked change in preferred anatomical route to the hip joint when performing total hip artrhroplasty (THA) for osteoarthritis in Norway. The direct lateral approach, which 10 years ago dominated, is today more or less abandoned. Several studies have reported inferior results in patients operated with the lateral approach compared to the posterior and anterior approaches, the latter approaches used in approximately 95 % of all THA´s i Norway. Many approaches are known for hip arthroplasty in trauma patients, but there is little consensus on the preferred method. The preferred surgical approach varies among hospitals and surgeons. Identifying the best possible approach for HA could lead to shorter hospital admission, faster rehabilitation, better functional outcomes, lower morbidity and mortality and improvement in patient independence. Consequently healthcare costs related to a hip fracture could be reduced. As of today the clinical results, reoperation rate and the morbidity have improved significantly in hemiarthroplasty treatment for dislocated femoral neck fractures. However, patients are primarily operated with the lateral approach, although inferior results are reported compared to posterior and anterior approaches. RCT´s from Ugland et al and Mjaaland have shown increased incidence of limping, lateral thigh pain and inferior PROM´s in patients operated with the direct lateral approach compared to patients operated with anterior approaches. A meta-analysis regarding hemiarthroplasty and surgical approaches from 2018 concluded that high-quality comparative studies are needed to further substantiate the preferred anatomic route for hemiarthroplasty in older femoral neck fracture patients.

Registry
clinicaltrials.gov
Start Date
January 21, 2022
End Date
October 1, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sorlandet Hospital HF
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients between 70 and 90 years of age
  • Displaced FNF
  • Ability to walk with or without a walking aid prior to falling
  • Patients having Sorlandet Hospital as primary service provider for orthopaedic trauma
  • Provision of informed consent by patient or proxy
  • Low energy fracture (fall from standing height, no other major trauma)

Exclusion Criteria

  • Fractures in pathologic bone
  • Patients not suited for HA (i.e., inflammatory arthritis, severe osteoarthritis)
  • Associated major injuries of the lower extremity ( i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula or femur)
  • Retained hardware around the affected hip that will interfere with arthroplasty
  • Sepsis or local infection

Outcomes

Primary Outcomes

Harris Hip Score

Time Frame: 2 years

The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent patient reported outcome measured by Harris Hip Score.

Secondary Outcomes

  • Bone Mineral Density(2 years)
  • Health-related quality of life (HRQoL)(2 years)
  • Muscle damage(2 years)
  • Radiographic stem positioning(2 years)

Study Sites (2)

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