Clinical trial NCT04900506: Surgical Approach in Hemiarthroplasty. A Randomized Clinical Trial Comparing Posterior and Anterior Approach
Official title: Cemented Hemiarthroplasty in Femoral Neck Fractures; Are Clinical Results Affected by Surgical Approach. A Randomized Clinical Trial Comparing Posterior and Anterior Approach
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Femoral Neck Fractures
Bone Mineral Density
Muscle Damage
Surgical Approach
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2021-05-25
Enrollment: 210
Sex: ALL
Minimum age (years): 70
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are allocated to either an anterior approach or a posterior approach after inclusion. Both groups are operated with a cemented hemiarthroplasty
Primary purpose: TREATMENT

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.

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:

* Dementia
* 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

Primary outcomes:
measure: Harris Hip Score
timeFrame: 2 years
Secondary outcomes:
measure: Bone Mineral Density
timeFrame: 2 years
measure: Muscle damage
timeFrame: 2 years
measure: Muscle damage
timeFrame: 2 years
measure: Muscle damage
timeFrame: 2 years
measure: Muscle damage
timeFrame: 2 years
measure: Health-related quality of life (HRQoL)
timeFrame: 2 years
measure: Health-related quality of life (HRQoL)
timeFrame: 2 years
measure: Health-related quality of life (HRQoL)
timeFrame: 2 years
measure: Radiographic stem positioning
timeFrame: 2 years
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Sorlandet Hospital
city: Kristiansand
country: Norway
facility: Sorlandet hospital
Study officials:
affiliation: Oslo University Hospital
name: Lars Nordsletten, MD,PhD,Professor
role: STUDY_DIRECTOR
References: