Bone Mineral DensityNCT03753100
Periprosthetic Bone Remodeling in Femoral Neck Fracture Patients; a 5-year Follow up Study
A study testing Dual-energy X-ray absorbtiometry to evaluate periprosthetic bone mineral density around an uncemented stem implanted using either lateral or anterolateral approach to the hip joint in people with Bone Mineral Density and Femoral Neck Fractures, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
Periprosthetic bone remodeling in femoral neck fracture patients: a 5-year follow up study addressing the influence of surgical approach on periprosthetic bone mineral density. Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Bone Mineral Density, Femoral Neck Fractures
- What is being tested?
- Dual-energy X-ray absorbtiometry to evaluate periprosthetic bone mineral density around an uncemented stem implanted using either lateral or anterolateral approach to the hip joint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2014to 25 Mar 2020
- 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 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients between 70 and 90 years of age with displaced femoral neck fractures
- Intact cognitive function
- Ability to walk with or without a walking aid prior to falling.
Who cannot join
- Dementia
- Fractures in pathologic bone
- Patients not belonging to the hospital community
- Patients with sepsis or local infection
- Fracture not eligible to be treated with a hemiarthroplasty
Trial locations and contacts
1 site in 1 country.
Norway1 site
Departement of Orthopaedics, Sorlandet Hospital
Kristiansand, 4600
About this study
Official title: Periprosthetic Bone Remodeling in Femoral Neck Fracture Patients: a 5-year Follow up Study Addressing the Influence of Surgical Approach on Periprosthetic Bone Mineral Density.
Periprosthetic bone remodeling in femoral neck fracture patients: a 5-year follow up study addressing the influence of surgical approach on periprosthetic bone mineral density.
Read the detailed description
Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand, Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468).Patients between 70 and 90 years of age with displaced femoral neck fractures, intact cognitive function and the ability to walk with or without a walking aid prior to falling were asked for their agreement to be enrolled and partition occurred after informed consent.A subgroup analysis looking at periprosthetic bone mineral density around the femoral component was part of this level 1 single-center randomized trial. 51 patients were enrolled in this DEXA study, and future examination of bone remodeling in these patients is now planned.
- Conditions
- Bone Mineral Density, Femoral Neck Fractures
- Being tested
- Dual-energy X-ray absorbtiometry to evaluate periprosthetic bone mineral density around an uncemented stem implanted using either lateral or anterolateral approach to the hip joint
- 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.
Dual-energy X-ray absorbtiometry to evaluate periprosthetic bone mineral density around an uncemented stem implanted using either lateral or anterolateral approach to the hip jointOther
The measurement will start in the area about 2 cm proximal to the greater trochanter and will stop slightly below the tip of the prosthesis. This is the baseline scan and will be carried out twice with the patient lying on the table, but with movement between each scan. This is done to calculate the CV, Coefficient of Variation. We will use the formula from Wilkinson and associates, where delta is standard deviations (SD) of the difference between the two BMD measurements for each patient. BMD has been measured at baseline, 3 and 12 months. A DXA scan is now planned at 60 months. Changes in BMD related to the 7 Gruen zones will be registered.
| Study group | Role | What they receive |
|---|---|---|
| Periprosthetic BMD; anterolateral approach | Active comparator | Periprosthetic bone mineral density will be measured using a DXA scanner from GE Lunar Prodigy. The initial scan was performed post-operatively during hospitalization Receives: Other: Dual-energy X-ray absorbtiometry to evaluate periprosthetic bone mineral density around an uncemented stem implanted using either lateral or anterolateral approach to the hip joint |
| Periprosthetic BMD; lateral approach | Active comparator | Periprosthetic bone mineral density will be measured using DXA scanner from GE Lunar Prodigy.The initial scan was performed post-operatively during hospitalization. Receives: Other: Dual-energy X-ray absorbtiometry to evaluate periprosthetic bone mineral density around an uncemented stem implanted using either lateral or anterolateral approach to the hip joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periprosthetic bone mineral density measured by dual-energy X-ray absorbtiometry
Change in bone mineral density
Measured: 5-year follow- up study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study startFeb 2014
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Mineral DensityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Glen Haugeberg, MD,PhD, Principal investigator, Department of Rheumatology, Sorlandet hospital, Kristiansand, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753100
- Sponsor's protocol ID
- Stein Ugland
- Status last verified
- Nov 2018
- First submitted
- 21 Nov 2018
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ugland SH, Ugland TO, Haugeberg G, Pripp AH, Nordsletten L. Periprosthetic bone mineral density, assessed using dual energy x-ray absorptiometry, following arthroplasty in patients with femoral neck fracture: 5-year outcomes of a randomized controlled trial. J Int Med Res. 2024 Sep;52(9):3000605241276491. doi: 10.1177/03000605241276491.
PubMed 39268760
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periprosthetic Bone Remodeling in Femoral Neck Fracture Patients: a 5-year Follow up Study Addressing the Influence of Surgical Approach on Periprosthetic Bone Mineral Density.
- ClinicalTrials.gov ID
- NCT03753100
- Acronym / sponsor ID
- Stein Ugland
- Conditions
- Bone Mineral Density, Femoral Neck Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Feb 2014 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 26 Nov 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.
Periprosthetic bone remodeling in femoral neck fracture patients: a 5-year follow up study addressing the influence of surgical approach on periprosthetic bone mineral density.
Detailed description
Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand, Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468).Patients between 70 and 90 years of age with displaced femoral neck fractures, intact cognitive function and the ability to walk with or without a walking aid prior to falling were asked for their agreement to be enrolled and partition occurred after informed consent.A subgroup analysis looking at periprosthetic bone mineral density around the femoral component was part of this level 1 single-center randomized trial. 51 patients were enrolled in this DEXA study, and future examination of bone remodeling in these patients is now planned.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periprosthetic BMD; anterolateral approach | Active comparator | Other: Dual-energy X-ray absorbtiometry to evaluate periprosthetic bone mineral density around an uncemented stem implanted using either lateral or anterolateral approach to the hip jointPeriprosthetic bone mineral density will be measured using a DXA scanner from GE Lunar Prodigy. The initial scan was performed post-operatively during hospitalization |
| Periprosthetic BMD; lateral approach | Active comparator | Other: Dual-energy X-ray absorbtiometry to evaluate periprosthetic bone mineral density around an uncemented stem implanted using either lateral or anterolateral approach to the hip jointPeriprosthetic bone mineral density will be measured using DXA scanner from GE Lunar Prodigy.The initial scan was performed post-operatively during hospitalization. |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients between 70 and 90 years of age with displaced femoral neck fractures
- Intact cognitive function
- Ability to walk with or without a walking aid prior to falling.
Key exclusion criteria (5 listed)
- Dementia
- Fractures in pathologic bone
- Patients not belonging to the hospital community
- Patients with sepsis or local infection
- Fracture not eligible to be treated with a hemiarthroplasty
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 |
|---|---|---|
| Dual-energy X-ray absorbtiometry to evaluate periprosthetic bone mineral density around an uncemented stem implanted using either lateral or anterolateral approach to the hip jointThe measurement will start in the area about 2 cm proximal to the greater trochanter and will stop slightly below the tip of the prosthesis. This is the baseline scan and will be carried out twice with the patient lying on the table, but with movement between each scan. This is done to calculate the CV, Coefficient of Variation. We will use the formula from Wilkinson and associates, where delta is standard deviations (SD) of the difference between the two BMD measurements for each patient. BMD has been measured at baseline, 3 and 12 months. A DXA scan is now planned at 60 months. Changes in BMD related to the 7 Gruen zones will be registered. | Other | Periprosthetic BMD; anterolateral approach, Periprosthetic BMD; lateral approach |
Primary outcome
Periprosthetic bone mineral density measured by dual-energy X-ray absorbtiometry
Time frame: 5-year follow- up study
Change in bone mineral density
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 26 Mar 2020.
- Derived from this study: PubMed 39268760Ugland SH, Ugland TO, Haugeberg G, Pripp AH, Nordsletten L. Periprosthetic bone mineral density, assessed using dual energy x-ray absorptiometry, following arthroplasty in patients with femoral neck fracture: 5-year outcomes of a randomized controlled trial. J Int Med Res. 2024 Sep;52(9):3000605241276491. doi: 10.1177/03000605241276491.
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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.
Glen Haugeberg, MD,PhD principal investigator
Department of Rheumatology, Sorlandet hospital, Kristiansand, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-energy X-ray absorbtiometry to evaluate periprosthetic bone mineral density around an uncemented stem implanted using either lateral or anterolateral approach to the hip joint in people with Bone Mineral Density and Femoral Neck Fractures, run by Sorlandet Hospital 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 5 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 26 Mar 2020. 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?
Periprosthetic bone mineral density measured by dual-energy X-ray absorbtiometry (time frame: 5-year follow- up study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03753100, which also lists 1 linked publication.
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 26 Mar 2020.