Surgical Approach in Hemiarthroplasty. A Randomized Clinical Trial Comparing Posterior and Anterior Approach

Not Applicable

Recruiting

• Conditions: Muscle Damage; Femoral Neck Fractures; Surgical Approach; Bone Mineral Density
• Interventions: Procedure: Posterior SPAIRE approach, anterior approach

• Registration Number: NCT04900506
• Lead Sponsor: Sorlandet Hospital HF

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.

Study Timeline

• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-25
• Study Start: 2022-01-21
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cemented hemiarthroplasty, anterior approach	Posterior SPAIRE approach, anterior approach	Anterior approach: supine position, both legs washed and draped, intermuscular plane between m. tensor fascia lata and m. sartorius, capsular T-incision, femoral neck resection, femoral canal reaming according to preoperative templating, third generation cementation technique, capsular repair
cemented hemiarthroplasty , posterior SPAIRE approach	Posterior SPAIRE approach, anterior approach	Posterior SPAIRE approach: lateral decubitus position, preservation of the piriformis tendon and obturator internus, detatchment of obturator externus , capsular T-incision, femoral neck resection, femoral canal reaming according to preoperative templating, third generation cementation technique, capsular repair, repair of obturator externus.

Primary Outcome Measures

Name	Time	Method
Harris Hip Score	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 Outcome Measures

Name	Time	Method
Bone Mineral Density	2 years	The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent postoperative changes in bone mineral density measured by dual-energy X-ray absorptiometry (DXA).
Health-related quality of life (HRQoL)	2 years	The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent health-related quality of life (HRQoL) measured by Visual Analog Score (VAS)
Muscle damage	2 years	The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent postoperative changes in clinical muscle damage measured by muscle strength
Radiographic stem positioning	2 years	The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent radiographic stem positioning.

Trial Locations

Locations (2)

Sorlandet hospital; 🇳🇴 Kristiansand, Norway

Sorlandet Hospital; 🇳🇴 Arendal, Norway