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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Femoral Neck Fractures; Bone Mineral Density; Muscle Damage; Surgical Approach
• Intervention / Treatment: Procedure: Posterior SPAIRE approach, anterior 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 Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stein H Ugland, MD; Phone Number: +4738074183 +4791626552; Email: stein.havard.ugland@sshf.no/steinugland@gmail.com

Study Locations

• Norway
  • Arendal, Norway
    • Recruiting
    • Sorlandet hospital
    • Contact: Knut Erik Mjaaland, MD, PhD; Email: knut.erik.mjaaland@sshf.no
  • Kristiansand, Norway
    • Recruiting
    • Sorlandet hospital
    • Contact: Stein Ugland, MD; Email: stein.havard.ugland@sshf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: cemented hemiarthroplasty , posterior SPAIRE 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.	Procedure: Posterior SPAIRE approach, anterior approach; Based on power calculation a sub-group analysis of 50 patients will be examined with DXA, all patients for biochemical and clinical muscle damage (CK, CRP, TUG-test, Trendelenburg, strenght test); Other Names: Bone Mineral Density; Biochemical muscle damage; Clinical muscle damage
Active Comparator: cemented hemiarthroplasty, 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	Procedure: Posterior SPAIRE approach, anterior approach; Based on power calculation a sub-group analysis of 50 patients will be examined with DXA, all patients for biochemical and clinical muscle damage (CK, CRP, TUG-test, Trendelenburg, strenght test); Other Names: Bone Mineral Density; Biochemical muscle damage; Clinical muscle damage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score	The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent patient reported outcome measured by Harris Hip Score.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Mineral Density	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).	2 years
Muscle damage	The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent postoperative changes in biochemical muscle damage measured by Creatin Kinase (CK)	2 years
Muscle damage	The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent postoperative changes in clinical muscle damage measured by TUG-test	2 years
Muscle damage	The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent postoperative changes in clinical muscle damage measured by Trendelenburg test	2 years
Muscle damage	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	2 years
Health-related quality of life (HRQoL)	The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent health-related quality of life (HRQoL) measured by HOOS	2 years
Health-related quality of life (HRQoL)	The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent health-related quality of life (HRQoL) measured by Eq-5d	2 years
Health-related quality of life (HRQoL)	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)	2 years
Radiographic stem positioning	The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent radiographic stem positioning.	2 years

Collaborators and Investigators

• Sponsor: Sorlandet Hospital HF
• Collaborators: South-Eastern Norway Regional Health Authority
• Investigators: Study Director: Lars Nordsletten, MD,PhD,Professor, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: Sorlandet HF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No