Hip FracturesNCT04870151
Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture
A study testing Anterolateral approach and Direct lateral approach in people with Hip Fractures, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
Patients with dislocated hip fractures are randomised to cemented hemiarthroplasty with an anterolateral approach or a direct lateral approach. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Anterolateral approach and Direct lateral approach
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- dislocated hip fracture.
- planned cemented hemiarthroplasty.
- able to walk, with or without walking aids, prior to the injury.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture: A Randomised Study
Patients with dislocated hip fractures are randomised to cemented hemiarthroplasty with an anterolateral approach or a direct lateral approach.
Read the 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.
- Conditions
- Hip Fractures
- Being tested
- Anterolateral approach, Direct lateral approach
- Keywords
- Surgical approach, Hemiarthroplasty
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterolateral approachProcedure or surgery
Cemented hemiarthroplasty using an anterolateral approach.
Direct lateral approachProcedure or surgery
Cemented hemiarthroplasty using a direct lateral approach.
| Study group | Role | What they receive |
|---|---|---|
| Anterolateral approach | Experimental | 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. Receives: Procedure: Anterolateral approach |
| Direct lateral approach | Active comparator | 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. Receives: Procedure: Direct lateral approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (11)
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).
Measured: 12 months
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".
Measured: 12 months
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".
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Blood loss
The peroperative amount of blood loss (milliliters) is registered
Measured: During surgery
Duration of surgery
The duration of the surgical procedure (minutes) is registered
Measured: During surgery
Length of hospital stay
The length of hospital stay (days) is registered
Measured: 12 months
Adverse events
Adverse events such as perioperative complications, infections, dislocations and reoperations are registered
Measured: 12 months
Mortality
In patients who die within 12 months follow-up, the time of death is registered
Measured: 12 months
Cause of death
In patients who die within 12 months follow-up, the cause of death is registered
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Jun 2021
- Primary completion19 May 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Håvard Furunes, PhD, Principal investigator, Sykehuset Innlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870151
- Sponsor's protocol ID
- 224045
- Status last verified
- May 2025
- First submitted
- 19 Apr 2021
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have planned to use all the IPD only within the present study group.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture: A Randomised Study
- ClinicalTrials.gov ID
- NCT04870151
- Acronym / sponsor ID
- 224045
- Conditions
- Hip Fractures
- Keywords
- Surgical approach, Hemiarthroplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 19 May 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Anterolateral approach | Experimental | Procedure: Anterolateral approachThe 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. |
| Direct lateral approach | Active comparator | Procedure: Direct lateral approachThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- dislocated hip fracture.
- planned cemented hemiarthroplasty.
- able to walk, with or without walking aids, prior to the injury.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterolateral approachCemented hemiarthroplasty using an anterolateral approach. | Procedure or surgery | Anterolateral approach |
| Direct lateral approachCemented hemiarthroplasty using a direct lateral approach. | Procedure or surgery | Direct lateral approach |
Primary outcome
Harris Hip Score (HHS)
Time frame: 12 months
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).
11 secondary outcomes
EuroQol questionnaire (EQ-5D)
Time frame: 12 months
Patient-reported limping
Time frame: 12 months
Patient-reported use of walking aid
Time frame: 12 months
Trendelenburg test
Time frame: 12 months
Timed Up and Go (TUG)
Time frame: 12 months
Blood loss
Time frame: During surgery
Duration of surgery
Time frame: During surgery
Length of hospital stay
Time frame: 12 months
Adverse events
Time frame: 12 months
Mortality
Time frame: 12 months
Cause of death
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No. We have planned to use all the IPD only within the present study group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Håvard Furunes, PhD principal investigator
Sykehuset Innlandet HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterolateral approach and Direct lateral approach in people with Hip Fractures, run by Sykehuset Innlandet HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score (HHS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.