Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Anterolateral approach

Direct lateral approach

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Surgical approach, Hemiarthroplasty

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

dislocated hip fracture.
planned cemented hemiarthroplasty.
able to walk, with or without walking aids, prior to the injury.

Exclusion Criteria:

young and healthy patients with displaced hip fractures who are recommended total hip arthroplasty or open reduction / internal fixation of the fracture.
patients with severe comorbidity and high risk of cement-related complications who are recommended uncemented hemiarthroplasty (some, but not all, patients with ASA (American Society of Anesthesiologists) grade 4).
not able to give informed consent.

Sites / Locations

Innlandet Hospital TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anterolateral approach

Direct lateral approach

Arm Description

The minimally invasive anterolateral approach (Watson-Jones approach) is performed with the patient in supine position. An oblique incision is made from just dorsal to the anterior superior iliac spine, and extended distally to the greater trochanter. After the fascia is incised, deep dissection continues in the plane between the tensor fasciae latae and the gluteus medius muscles. The joint capsule is exposed and opened. The femoral head and neck are resected and the femoral canal is reamed according to the preoperative plan. A femoral stem (Link Lubinus SPII) is fixed using bone cement (Heraeus Medical Palacos R+G pro) and connected to a bipolar femoral head (Zimmer Multipolar). After implantation of the prosthesis, the fascia, subcutis and skin is closed in separate layers with sutures.

The direct lateral approach (Hardinge approach) is performed with the patient in a lateral decubitus position. A straight or curved longitudinal incision is made over the greater trochanter, and the fascia is incised longitudinally. The anterior aspect of the gluteus medius and minimus muscles are separated from the greater trochanter. The joint capsule is exposed and opened. The femoral head and neck are resected and the femoral canal is reamed according to the preoperative plan. A femoral stem (Link Lubinus SPII) is fixed using bone cement (Heraeus Medical Palacos R+G pro) and connected to a bipolar femoral head (Zimmer Multipolar). After implantation of the prosthesis, the gluteus medius and minimus muscles are reinserted using osteosutures. The fascia, subcutis and skin is closed in separate layers with sutures.

Outcomes

Primary Outcome Measures

Harris Hip Score (HHS)

Harris Hip Score (HHS) is an outcome measure for hip-related symptoms. The score is based on both patient-reported information and clinical examination, and is administered by a qualified health care professional. It covers four domains: Pain, function, absence of deformity and range of motion. The score ranges from 0 (worst) to 100 (best).

Secondary Outcome Measures

EuroQol questionnaire (EQ-5D)

Quality of life is measured by the EuroQol questionnaire (EQ-5D). EQ-5D is a validated generic health-related quality-of-life instrument. It consists of two parts: EQ-5D descriptive part and EQ-5D visual analogue scale. The descriptive part includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with three possible answers ("no problems", "some problems", and "major problems"). EQ-5D VAS is a visual analogue scale of self-related overall health, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

Patient-reported limping

Patient-reported limping is a sub-score of the Harris Hip Score. The patients describe their limping as (1) "none", (2) "slight", (3) "moderate" or (4) "severe or unable to walk".

Patient-reported use of walking aid

Patient-reported use of walking aid is a sub-score of the Harris Hip Score. The patients describe their use of walking aid as (1) "none", (2) "cane/walking stick for long walks", (3) "cane/walking stick most of the time", (4) "one crutch", (5) "two canes/walking sticks" or (6) "two crutches or unable to walk".

Trendelenburg test

Trendelenburg test is a clinical test for the integrity of hip abductor muscle function. The test is positive when the patient is unable to maintain the pelvis horizontal to the floor when standing on one leg.

Timed Up and Go (TUG)

The Timed Up and Go (TUG) test is a performance-based measure of functional mobility that was initially developed to identify mobility and balance impairments in older adults. The patients start in a seated position, walk 3 meters, turn around, walk back to the chair and sit down. The time starts when the patient is commanded to start and stops when the patient is seated.

Blood loss

The peroperative amount of blood loss (milliliters) is registered

Duration of surgery

The duration of the surgical procedure (minutes) is registered

Length of hospital stay

The length of hospital stay (days) is registered

Adverse events

Adverse events such as perioperative complications, infections, dislocations and reoperations are registered

Mortality

In patients who die within 12 months follow-up, the time of death is registered

Cause of death

In patients who die within 12 months follow-up, the cause of death is registered

Full Information

NCT ID

NCT04870151

First Posted

April 19, 2021

Last Updated

September 29, 2022

Sponsor

Sykehuset Innlandet HF

1. Study Identification

Unique Protocol Identification Number

NCT04870151

Brief Title

Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture

Official Title

Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture: A Randomised Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sykehuset Innlandet HF

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

Patients with dislocated hip fractures are randomised to cemented hemiarthroplasty with an anterolateral approach or a direct lateral approach.

Detailed Description

Dislocated intracapsular hip fractures are usually treated with cemented hemiarthroplasty. In Norway, a direct lateral approach is most often used, as recommended in national guidelines. In total hip arthroplasty, however, minimally invasive approaches are also commonly used, and may improve the clinical results, as compared to posterior or direct lateral approaches. The aims of the present study are to evaluate the effect of the minimally invasive anterolateral approach (Watson-Jones approach) compared to the direct lateral approach (Hardinge approach) to the hip joint in hemiarthroplasty after dislocated hip fractures. Patients with dislocated hip fractures who are fit for cemented hemiarthroplasty are randomised to surgery with an anterolateral approach or a direct lateral approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Fractures

Keywords

Surgical approach, Hemiarthroplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomised controlled trial

Masking

Outcomes Assessor

Masking Description

The outcomes assessors are instructed to assess the outcomes before they log in to the patients' journal. Thereby, they will not have information of the treatment allocation at the time of outcomes assessment. Also, they will not ask the patients to undress or in any other way examine the surgical site, as the location of the scar tissue may disclose the treatment allocation.

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Anterolateral approach

Arm Type

Experimental

Arm Description

The minimally invasive anterolateral approach (Watson-Jones approach) is performed with the patient in supine position. An oblique incision is made from just dorsal to the anterior superior iliac spine, and extended distally to the greater trochanter. After the fascia is incised, deep dissection continues in the plane between the tensor fasciae latae and the gluteus medius muscles. The joint capsule is exposed and opened. The femoral head and neck are resected and the femoral canal is reamed according to the preoperative plan. A femoral stem (Link Lubinus SPII) is fixed using bone cement (Heraeus Medical Palacos R+G pro) and connected to a bipolar femoral head (Zimmer Multipolar). After implantation of the prosthesis, the fascia, subcutis and skin is closed in separate layers with sutures.

Arm Title

Direct lateral approach

Arm Type

Active Comparator

Arm Description

The direct lateral approach (Hardinge approach) is performed with the patient in a lateral decubitus position. A straight or curved longitudinal incision is made over the greater trochanter, and the fascia is incised longitudinally. The anterior aspect of the gluteus medius and minimus muscles are separated from the greater trochanter. The joint capsule is exposed and opened. The femoral head and neck are resected and the femoral canal is reamed according to the preoperative plan. A femoral stem (Link Lubinus SPII) is fixed using bone cement (Heraeus Medical Palacos R+G pro) and connected to a bipolar femoral head (Zimmer Multipolar). After implantation of the prosthesis, the gluteus medius and minimus muscles are reinserted using osteosutures. The fascia, subcutis and skin is closed in separate layers with sutures.

Intervention Type

Procedure

Intervention Name(s)

Anterolateral approach

Intervention Description

Cemented hemiarthroplasty using an anterolateral approach.

Intervention Type

Procedure

Intervention Name(s)

Direct lateral approach

Intervention Description

Cemented hemiarthroplasty using a direct lateral approach.

Primary Outcome Measure Information:

Title

Harris Hip Score (HHS)

Description

Harris Hip Score (HHS) is an outcome measure for hip-related symptoms. The score is based on both patient-reported information and clinical examination, and is administered by a qualified health care professional. It covers four domains: Pain, function, absence of deformity and range of motion. The score ranges from 0 (worst) to 100 (best).

Time Frame

12 months

Secondary Outcome Measure Information:

Title

EuroQol questionnaire (EQ-5D)

Description

Quality of life is measured by the EuroQol questionnaire (EQ-5D). EQ-5D is a validated generic health-related quality-of-life instrument. It consists of two parts: EQ-5D descriptive part and EQ-5D visual analogue scale. The descriptive part includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with three possible answers ("no problems", "some problems", and "major problems"). EQ-5D VAS is a visual analogue scale of self-related overall health, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

Time Frame

12 months

Title

Patient-reported limping

Description

Patient-reported limping is a sub-score of the Harris Hip Score. The patients describe their limping as (1) "none", (2) "slight", (3) "moderate" or (4) "severe or unable to walk".

Time Frame

12 months

Title

Patient-reported use of walking aid

Description

Patient-reported use of walking aid is a sub-score of the Harris Hip Score. The patients describe their use of walking aid as (1) "none", (2) "cane/walking stick for long walks", (3) "cane/walking stick most of the time", (4) "one crutch", (5) "two canes/walking sticks" or (6) "two crutches or unable to walk".

Time Frame

12 months

Title

Trendelenburg test

Description

Trendelenburg test is a clinical test for the integrity of hip abductor muscle function. The test is positive when the patient is unable to maintain the pelvis horizontal to the floor when standing on one leg.

Time Frame

12 months

Title

Timed Up and Go (TUG)

Description

The Timed Up and Go (TUG) test is a performance-based measure of functional mobility that was initially developed to identify mobility and balance impairments in older adults. The patients start in a seated position, walk 3 meters, turn around, walk back to the chair and sit down. The time starts when the patient is commanded to start and stops when the patient is seated.

Time Frame

12 months

Title

Blood loss

Description

The peroperative amount of blood loss (milliliters) is registered

Time Frame

During surgery

Title

Duration of surgery

Description

The duration of the surgical procedure (minutes) is registered

Time Frame

During surgery

Title

Length of hospital stay

Description

The length of hospital stay (days) is registered

Time Frame

12 months

Title

Adverse events

Description

Adverse events such as perioperative complications, infections, dislocations and reoperations are registered

Time Frame

12 months

Title

Mortality

Description

In patients who die within 12 months follow-up, the time of death is registered

Time Frame

12 months

Title

Cause of death

Description

In patients who die within 12 months follow-up, the cause of death is registered

Time Frame

12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: dislocated hip fracture. planned cemented hemiarthroplasty. able to walk, with or without walking aids, prior to the injury. Exclusion Criteria: young and healthy patients with displaced hip fractures who are recommended total hip arthroplasty or open reduction / internal fixation of the fracture. patients with severe comorbidity and high risk of cement-related complications who are recommended uncemented hemiarthroplasty (some, but not all, patients with ASA (American Society of Anesthesiologists) grade 4). not able to give informed consent.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Håvard Furunes, PhD

Phone

99041763

Ext

0047

Email

havardfurunes@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Audun D Bøhn, MD

Phone

90952322

Ext

0047

Email

audun.bohn@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Håvard Furunes, PhD

Organizational Affiliation

Sykehuset Innlandet HF

Official's Role

Principal Investigator

Facility Information:

Facility Name

Innlandet Hospital Trust

City

Gjøvik

State/Province

Innlandet

ZIP/Postal Code

2819

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Håvard Furunes, PhD

Phone

99041763

Ext

0047

Email

havardfurunes@gmail.com

First Name & Middle Initial & Last Name & Degree

Audun D Bøhn, MD

Phone

90952322

Ext

0047

Email

audun.bohn@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

No

IPD Sharing Plan Description

We have planned to use all the IPD only within the present study group.

Hip Fractures

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial