Femoral Neck FracturesNCT03695497
Direct Anterior Approach for Femoral Neck Fractures
A study testing Direct anterior approach and Direct Lateral Approach in people with Femoral Neck Fractures, run by Helse Møre og Romsdal HF at 1 site in Norway.
Trial summary
The primary objective is to examine if in patients with a dislocated femoral neck fracture who receive a total hip arthroplasty, direct anterior approach will give a better result in terms of mobilization, function and pain in the first weeks and months postoperatively, than direct lateral approach. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Direct anterior approach and Direct Lateral Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2018to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dislocated femoral neck fracture
Who cannot join
- Infection around the hip (soft tissue or bone)
- Pathologic fracture
- Excessive alcohol or substance abuse that most likely will give reduced compliance
- Patients with any fractures of the long bones in the lower extremity, fracture of the spine, and/or intra-thoracic or intra-abdominal injury (i.e., multiple trauma). Because the outcomes and clinical course of patients with multiple trauma may be quite different from a non-trauma patient.
- Bedridden patients/non-walkers
- Patients with an underlying illness that doesn't have life expectancy beyond six months
- In case of severe cognitive impairment where the patients are not able to give their informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Direct Anterior Approach to Direct Lateral Approach in Patients Receiving a Total Hip Arthroplasty for Femoral Neck Fracture - a 1 Year Follow-up Study
The primary objective is to examine if in patients with a dislocated femoral neck fracture who receive a total hip arthroplasty, direct anterior approach will give a better result in terms of mobilization, function and pain in the first weeks and months postoperatively, than direct lateral approach.
Read the detailed description
first included patient 23th November 2018
- Conditions
- Femoral Neck Fractures
- Being tested
- Direct anterior approach, Direct Lateral Approach
- Keywords
- Arthroplasty, Replacement, Hip, Orthopedic procedures
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct anterior approachProcedure or surgery
Also called DAA
total hip arthroplasty with DAA
Direct Lateral ApproachProcedure or surgery
Also called DLA
total hip arthroplasty with DLA
| Study group | Role | What they receive |
|---|---|---|
| Direct anterior approach | Experimental | total hip arthroplasty with direct anterior approach Receives: Procedure: Direct anterior approach |
| Direct Lateral Approach | Experimental | total hip arthroplasty with direct lateral approach Receives: Procedure: Direct Lateral Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Timed Up and Go Test (TUG) between the groups
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: 6 weeks postoperatively.
Secondary outcomes (12)
Difference in Forgotten Joint Score for hip (FJS-12) between the groups
12 questions. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48*100) For the final 'Forgotten Joint Score -12' a high score indicates good outcome.
Measured: 2,6,12 weeks, and 1 year
Difference in EQ-5D-5L score between the groups
5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be' 12233'. As there is no Norwegian index, the EQ5D-5L was converted into a Swedish index score.
Measured: 2,6,12 weeks, and 1 year
Difference in Oxford Hip Score (OHS) between the groups
12 questions. Every question is scored 4 to 0 according to the selected response. Thus the highest score on 48 means a perfectly functioning hip, while a score on 0 means the worst outcome.
Measured: 2,6,12 weeks, and 1 year
Difference in Timed Up and Go Test (TUG) between the groups
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down
Measured: 2,12 weeks, 1 year.
Difference in EQ5D-VAS between the groups
Respondents report their perceived health status with a grade ranging from 0 (worst possible health status) to 100 (best possible health status).
Measured: 2,6,12 weeks, and 1 year
radiological results 1.
We will look at the offset of the hip prosthesis.
Measured: postoperative, 3,12 months.
radiological results 2.
We will look at alignment of the stem. Femoral component angulation between 3° varus and 3° valgus relative to the femoral shaft axis will be considered neutral. Positioning outside this references will be graded as varus or valgus
Measured: postoperative, 3,12 months.
radiological results 3.
We will look at quality of stem cementation by Barrack
Measured: postoperative, 3,12 months.
radiological results 4.
We will look at leg length. It will be measured using the vertical height from the interteardrop line.
Measured: postoperative, 3,12 months.
radiological results 5.
We will look at inclination of the cup.It will be measured in reference to the interteardrop line.
Measured: postoperative, 3,12 months.
radiological results 6.
We will look at anteversion of the cup. It will be measured using the ischiolateral method.
Measured: postoperative, 3,12 months.
complications
periprosthetic fractures, dislocation, implant failure, neurovascular injury, infection. abductor failure, neurapraxia of LFCN), and mortality
Measured: Within the first year postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start1 Oct 2018
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck 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
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Collaborators
- St. Olavs Hospital, Kristiansund Hospital
- Responsible party
- Sponsor
- Investigators
- Øystein B Lian, md phd, Study chair, Helse Møre og Romsdal Hospital Trust (HF), Kristiansund Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695497
- Sponsor's protocol ID
- 2018/935
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2018
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Direct Anterior Approach to Direct Lateral Approach in Patients Receiving a Total Hip Arthroplasty for Femoral Neck Fracture - a 1 Year Follow-up Study
- ClinicalTrials.gov ID
- NCT03695497
- Acronym / sponsor ID
- 2018/935
- Conditions
- Femoral Neck Fractures
- Keywords
- Arthroplasty, Replacement, Hip, Orthopedic procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Collaborators
- St. Olavs Hospital, Kristiansund Hospital
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 4 Oct 2018 (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.
The primary objective is to examine if in patients with a dislocated femoral neck fracture who receive a total hip arthroplasty, direct anterior approach will give a better result in terms of mobilization, function and pain in the first weeks and months postoperatively, than direct lateral approach.
Detailed description
first included patient 23th November 2018
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct anterior approach | Experimental | Procedure: Direct anterior approachtotal hip arthroplasty with direct anterior approach |
| Direct Lateral Approach | Experimental | Procedure: Direct Lateral Approachtotal hip arthroplasty with direct lateral approach |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dislocated femoral neck fracture
Key exclusion criteria (7 listed)
- Infection around the hip (soft tissue or bone)
- Pathologic fracture
- Excessive alcohol or substance abuse that most likely will give reduced compliance
- Patients with any fractures of the long bones in the lower extremity, fracture of the spine, and/or intra-thoracic or intra-abdominal injury (i.e., multiple trauma). Because the outcomes and clinical course of patients with multiple trauma may be quite different from a non-trauma patient.
- Bedridden patients/non-walkers
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 |
|---|---|---|
| Direct anterior approachAlso: DAAtotal hip arthroplasty with DAA | Procedure or surgery | Direct anterior approach |
| Direct Lateral ApproachAlso: DLAtotal hip arthroplasty with DLA | Procedure or surgery | Direct Lateral Approach |
Primary outcome
Difference in Timed Up and Go Test (TUG) between the groups
Time frame: 6 weeks postoperatively.
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
12 secondary outcomes
Difference in Forgotten Joint Score for hip (FJS-12) between the groups
Time frame: 2,6,12 weeks, and 1 year
Difference in EQ-5D-5L score between the groups
Time frame: 2,6,12 weeks, and 1 year
Difference in Oxford Hip Score (OHS) between the groups
Time frame: 2,6,12 weeks, and 1 year
Difference in Timed Up and Go Test (TUG) between the groups
Time frame: 2,12 weeks, 1 year.
Difference in EQ5D-VAS between the groups
Time frame: 2,6,12 weeks, and 1 year
radiological results 1.
Time frame: postoperative, 3,12 months.
radiological results 2.
Time frame: postoperative, 3,12 months.
radiological results 3.
Time frame: postoperative, 3,12 months.
radiological results 4.
Time frame: postoperative, 3,12 months.
radiological results 5.
Time frame: postoperative, 3,12 months.
radiological results 6.
Time frame: postoperative, 3,12 months.
complications
Time frame: Within the first year postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Øystein B Lian, md phd study chair
Helse Møre og Romsdal Hospital Trust (HF), Kristiansund Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct anterior approach and Direct Lateral Approach in people with Femoral Neck Fractures, run by Helse Møre og Romsdal 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 1 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in Timed Up and Go Test (TUG) between the groups (time frame: 6 weeks postoperatively.). 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 1 Nov 2024.