Gait AnalysisNCT04791605
Gait Pattern Between a Cemented and Non-cemented Femur Stem
A study testing Gait analysis in people with Gait Analysis and Hip Fractures, run by Göteborg University at 1 site in Sweden.
Trial summary
Acute cervical femoral neck fracture patients randomized to either cemented or non-cemented stem. The investigators used gait analysis to evaluate if patients operated with a cemented stem showed more favourable hip kinematics and kinetics when compared with a group of patients operated with a non-cemented stem. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gait Analysis, Hip Fractures, Hip Arthroplasty
- What is being tested?
- Gait analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2012to 1 Mar 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- acute collum femoris fracture
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: No Difference in Gait Pattern Between a Cemented and Non-cemented Femur Stem. 45 Prospective Randomized Total Hip Arthroplasty Patients After Acute Cervical Femur Fracture Evaluated After 2 Years
Acute cervical femoral neck fracture patients randomized to either cemented or non-cemented stem. The investigators used gait analysis to evaluate if patients operated with a cemented stem showed more favourable hip kinematics and kinetics when compared with a group of patients operated with a non-cemented stem.
Read the detailed description
45 patients randomized to receive either a cemented or a non-cemented stem were studied . 2 years after the operation gait analysis was performed with a 16-camera motion capture system together with 2 force-plates. Hip kinematics and kinetics were analysed and 70 subjects served as controls.
- Conditions
- Gait Analysis, Hip Fractures, Hip Arthroplasty, Randomized
- Being tested
- Gait analysis
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisOther
Kinematic and kinetic analysis
| Study group | Role | What they receive |
|---|---|---|
| Gait analysis of cemented total hip | Experimental | Gait analysis of acute collum femoris fracture patient randomized to cemented stem Receives: Other: Gait analysis |
| Gait analysis of non-cemented total hip | Experimental | Gait analysis of acute collum femoris fracture patient randomized to non-cemented stem Receives: Other: Gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Analysis with focus on hip kinematics 2 year after total hip arthroplasty
Optical tracking system focusing on reflective markers according a model used in gait analysis in order to record degrees of hip angels in 3 planes
Measured: 2 year postop
Gait Analysis with focus on hip kinetics 2 year after total hip arthroplasty
Optical tracking system focusing on reflective markers according a model used in gait analysis together with force plates record hip moments (Nm/kg) in 3 planes
Measured: 2 year postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Jan 2012
- Primary completion28 Feb 2021
- Study completion1 Mar 2021
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 Gait AnalysisStudies 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
- Gait of cemented femur stem of acute cervical collum femoris stem. Gait of non-cemented femur stem of acute cervical collum femoris stem.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Zügner, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791605
- Sponsor's protocol ID
- Cemented and non-cemented stem
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zugner R, Tranberg R, Sharegi B, Karrholm J. Gait pattern in patients treated with a total hip arthroplasty due to an acute displaced cervical neck fracture: a randomised comparison between 29 cases with a cemented femoral stem and 16 cases with an uncemented femoral stem. Hip Int. 2024 May;34(3):421-427. doi: 10.1177/11207000231208099. Epub 2023 Dec 12.
PubMed 38087800
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Difference in Gait Pattern Between a Cemented and Non-cemented Femur Stem. 45 Prospective Randomized Total Hip Arthroplasty Patients After Acute Cervical Femur Fracture Evaluated After 2 Years
- ClinicalTrials.gov ID
- NCT04791605
- Acronym / sponsor ID
- Cemented and non-cemented stem
- Conditions
- Gait Analysis, Hip Fractures, Hip Arthroplasty, Randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 10 Mar 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.
Acute cervical femoral neck fracture patients randomized to either cemented or non-cemented stem. The investigators used gait analysis to evaluate if patients operated with a cemented stem showed more favourable hip kinematics and kinetics when compared with a group of patients operated with a non-cemented stem.
Detailed description
45 patients randomized to receive either a cemented or a non-cemented stem were studied . 2 years after the operation gait analysis was performed with a 16-camera motion capture system together with 2 force-plates. Hip kinematics and kinetics were analysed and 70 subjects served as controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Gait of cemented femur stem of acute cervical collum femoris stem. Gait of non-cemented femur stem of acute cervical collum femoris stem.
| Arm | Type | Receives |
|---|---|---|
| Gait analysis of cemented total hip | Experimental | Other: Gait analysisGait analysis of acute collum femoris fracture patient randomized to cemented stem |
| Gait analysis of non-cemented total hip | Experimental | Other: Gait analysisGait analysis of acute collum femoris fracture patient randomized to non-cemented stem |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- acute collum femoris fracture
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Gait analysisKinematic and kinetic analysis | Other | Gait analysis of cemented total hip, Gait analysis of non-cemented total hip |
Primary outcome
Gait Analysis with focus on hip kinematics 2 year after total hip arthroplasty
Time frame: 2 year postop
Optical tracking system focusing on reflective markers according a model used in gait analysis in order to record degrees of hip angels in 3 planes
Gait Analysis with focus on hip kinetics 2 year after total hip arthroplasty
Time frame: 2 year postop
Optical tracking system focusing on reflective markers according a model used in gait analysis together with force plates record hip moments (Nm/kg) in 3 planes
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 10 Mar 2021.
- Derived from this study: PubMed 38087800Zugner R, Tranberg R, Sharegi B, Karrholm J. Gait pattern in patients treated with a total hip arthroplasty due to an acute displaced cervical neck fracture: a randomised comparison between 29 cases with a cemented femoral stem and 16 cases with an uncemented femoral stem. Hip Int. 2024 May;34(3):421-427. doi: 10.1177/11207000231208099. Epub 2023 Dec 12.
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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.
Roland Zügner principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait analysis in people with Gait Analysis and Hip Fractures, run by Göteborg University at 1 site in Sweden.
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 1 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 10 Mar 2021. 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 Sweden. 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?
Gait Analysis with focus on hip kinematics 2 year after total hip arthroplasty (time frame: 2 year postop). The study lists 2 primary outcomes in all. 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 NCT04791605, 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 10 Mar 2021.