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

Femoral Neck Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04900506
• Other study ID #: Sorlandet HF
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Sorlandet Hospital HF
• Contact: Stein H Ugland, MD
• Phone: +4791626552
• Email: stein.havard.ugland[@]sshf.no/steinugland[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
Norway	Sorlandet Hospital	Arendal
Norway	Sorlandet hospital	Kristiansand

Sponsors (2)

Lead Sponsor	Collaborator
Sorlandet Hospital HF	South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Radiographic stem positioning	The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent radiographic stem positioning.	2 years