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

Primary Purpose

Femoral Neck Fractures, Bone Mineral Density, Muscle Damage

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Posterior SPAIRE approach, anterior approach
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures

Eligibility Criteria

70 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sorlandet Hospital
  • Sorlandet hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

cemented hemiarthroplasty , posterior SPAIRE approach

cemented hemiarthroplasty, anterior approach

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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)
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
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
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
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
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
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)
Radiographic stem positioning
The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent radiographic stem positioning.

Full Information

First Posted
May 5, 2021
Last Updated
February 3, 2023
Sponsor
Sorlandet Hospital HF
Collaborators
South-Eastern Norway Regional Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT04900506
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF
Collaborators
South-Eastern Norway Regional Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures, Bone Mineral Density, Muscle Damage, Surgical Approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are allocated to either an anterior approach or a posterior approach after inclusion. Both groups are operated with a cemented hemiarthroplasty
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cemented hemiarthroplasty , posterior SPAIRE approach
Arm Type
Active Comparator
Arm Description
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.
Arm Title
cemented hemiarthroplasty, anterior approach
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Posterior SPAIRE approach, anterior approach
Other Intervention Name(s)
Bone Mineral Density, Biochemical muscle damage, Clinical muscle damage
Intervention Description
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)
Primary Outcome Measure Information:
Title
Harris Hip Score
Description
The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent patient reported outcome measured by Harris Hip Score.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Bone Mineral Density
Description
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).
Time Frame
2 years
Title
Muscle damage
Description
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)
Time Frame
2 years
Title
Muscle damage
Description
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
Time Frame
2 years
Title
Muscle damage
Description
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
Time Frame
2 years
Title
Muscle damage
Description
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
Time Frame
2 years
Title
Health-related quality of life (HRQoL)
Description
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
Time Frame
2 years
Title
Health-related quality of life (HRQoL)
Description
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
Time Frame
2 years
Title
Health-related quality of life (HRQoL)
Description
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)
Time Frame
2 years
Title
Radiographic stem positioning
Description
The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent radiographic stem positioning.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stein H Ugland, MD
Phone
+4791626552
Ext
+4738074183
Email
stein.havard.ugland@sshf.no/steinugland@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Nordsletten, MD,PhD,Professor
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sorlandet Hospital
City
Arendal
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Knut Erik Mjaaland, MD, PhD
Email
knut.erik.mjaaland@sshf.no
Facility Name
Sorlandet hospital
City
Kristiansand
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stein Ugland, MD
Email
stein.havard.ugland@sshf.no

12. IPD Sharing Statement

Learn more about this trial

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

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