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

NCT04900506 | Active Not Recruiting

• 1 other identifier: Sorlandet HF
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 2

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.

Conditions

Femoral Neck Fractures; Bone Mineral Density; Muscle Damage; Surgical Approach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Bone Mineral Density

  2 years

• Muscle damage

  2 years

• Muscle damage

  2 years

• Muscle damage

  2 years

• Muscle damage

  2 years

Study Arms (2)

cemented hemiarthroplasty , posterior SPAIRE approach

ACTIVE COMPARATOR

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

cemented hemiarthroplasty, anterior approach

ACTIVE COMPARATOR

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

Interventions

Posterior SPAIRE approach, anterior approach PROCEDURE

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)

Also known as: Bone Mineral Density, Biochemical muscle damage, Clinical muscle damage

cemented hemiarthroplasty , posterior SPAIRE approach; cemented hemiarthroplasty, anterior approach

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorlandet Hospital HF: lead
• South-Eastern Norway Regional Health Authority: collaborator

Study Sites (2)

Sorlandet Hospital

Arendal, Norway

Location

Sorlandet hospital

Kristiansand, Norway

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Bone Density

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lars Nordsletten, MD,PhD,Professor

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to allocation by not having access to patients study protocol and by examining patients covering their operated hip with clothing. Patients are attempted blinded by using wound dressings to cover their operated hip and are, unless expressing specific interest in knowing the surgical approach, not informed of the randomization result. To evaluate the blinding of patients we will record their knowledge of which surgical approach they were operated with at their 12-month follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Patients are allocated to either an anterior approach or a posterior approach after inclusion. Both groups are operated with a cemented hemiarthroplasty

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 25, 2021
• Study Start: January 21, 2022
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 5, 2025

Record last verified: 2024-11

Locations

NO (2)