Femoral Neck FractureNCT02897440
Full Versus Partial Repairing of Soft Tissue Surrounding the Hip in Arthroplasty for Femoral Neck Fractures
An observational study of Femoral Neck Fracture, run by First Hospitals affiliated to the China PLA General Hospital.
Trial summary
A prospective cohort study to compare full repairing and partial repairing of soft tissue surrounding the hip joint in anteriorolateral approaching arthroplasty concerning hip function. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femoral Neck Fracture
- What is being tested?
- Full Repairng of soft tissue surrounding the hip and Partial Repairng of soft tissue surrounding the hip
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Dec 2017
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with femoral neck fractures undergoing hip arthroplasty through anteriorolateral approach.
Who may be able to join
- Displaced femoral neck fracture
- Walker
- Hemiarthroplasty or Total Hip Arthroplasty
- Preiffer test >7/10
Who cannot join
- Pathological fracture
- Non-walker
- Pfeiffer test <7/10 indicating mental alteration
About this study
Official title: Full Repairing Versus Partial Repairing of Soft Tissue Surrounding the Hip Joint in Hip Arthroplasty for Femoral Neck Fractures
A prospective cohort study to compare full repairing and partial repairing of soft tissue surrounding the hip joint in anteriorolateral approaching arthroplasty concerning hip function. Patients admitted with a femoral neck fracture operated with a hip arthroplasty through an anteriorolateral approach were screened for inclusion. Patients with altered mental status SPMSQ <7, pathological fractures, non-walkers were excluded.
Read the detailed description
Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 2 months postoperatively by clinical examination. Sample size were estimated to 15 patients in each group. Primary outcome variables were trendelenburg test, abductor strength measured with dynamometry. Secondary outcome variables were WOMAC, EQ-5D, and VAS scores.
- Conditions
- Femoral Neck Fracture
- Being tested
- Full Repairng of soft tissue surrounding the hip, Partial Repairng of soft tissue surrounding the hip
- Keywords
- Femoral Neck Fracture, Hip Arthroplasty, Repairing of soft tissue
- 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.
Full Repairng of soft tissue surrounding the hipProcedure or surgery
Full repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting.
Partial Repairng of soft tissue surrounding the hipProcedure or surgery
Partial repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting.
| Study group | Role | What they receive |
|---|---|---|
| Full Repairing of soft tissue surrounding the hip | Full repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting Receives: Procedure: Full Repairng of soft tissue surrounding the hip | |
| Partial Repairing of soft tissue surrounding the hip | Partial repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting Receives: Procedure: Partial Repairng of soft tissue surrounding the hip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trendelenburg Test
30 seconds standing on the operated leg
Measured: At 4 week postoperatively
Abductor strength
Dynamometry
Measured: At 4 week postoperatively
Secondary outcomes (3)
WOMAC
An established hip score
Measured: At 2, 4, 6 weeks and 12 months postoperatively
Quality of life (EQ-5D)
EQ-5D
Measured: At 2, 4, 6 weeks and 12 months postoperatively
Pain (Visual analouge scale)
Visual analouge scale (VAS): At rest and during activity
Measured: At 2, 4, 6 weeks and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FractureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospitals affiliated to the China PLA General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Haibo Lu, First Hospitals affiliated to the China PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897440
- Sponsor's protocol ID
- 1
- Status last verified
- Sep 2016
- First submitted
- 24 Aug 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full Repairing Versus Partial Repairing of Soft Tissue Surrounding the Hip Joint in Hip Arthroplasty for Femoral Neck Fractures
- ClinicalTrials.gov ID
- NCT02897440
- Acronym / sponsor ID
- 1
- Conditions
- Femoral Neck Fracture
- Keywords
- Femoral Neck Fracture, Hip Arthroplasty, Repairing of soft tissue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Hospitals affiliated to the China PLA General HospitalOther government
- Study start
- Oct 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- 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.
A prospective cohort study to compare full repairing and partial repairing of soft tissue surrounding the hip joint in anteriorolateral approaching arthroplasty concerning hip function. Patients admitted with a femoral neck fracture operated with a hip arthroplasty through an anteriorolateral approach were screened for inclusion. Patients with altered mental status SPMSQ <7, pathological fractures, non-walkers were excluded.
Detailed description
Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 2 months postoperatively by clinical examination. Sample size were estimated to 15 patients in each group. Primary outcome variables were trendelenburg test, abductor strength measured with dynamometry. Secondary outcome variables were WOMAC, EQ-5D, and VAS scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Repairing of soft tissue surrounding the hip | – | Procedure: Full Repairng of soft tissue surrounding the hipFull repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting |
| Partial Repairing of soft tissue surrounding the hip | – | Procedure: Partial Repairng of soft tissue surrounding the hipPartial repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with femoral neck fractures undergoing hip arthroplasty through anteriorolateral approach.
Key inclusion criteria (4 listed)
- Displaced femoral neck fracture
- Walker
- Hemiarthroplasty or Total Hip Arthroplasty
- Preiffer test >7/10
Key exclusion criteria (3 listed)
- Pathological fracture
- Non-walker
- Pfeiffer test <7/10 indicating mental alteration
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 |
|---|---|---|
| Full Repairng of soft tissue surrounding the hipFull repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting. | Procedure or surgery | Full Repairing of soft tissue surrounding the hip |
| Partial Repairng of soft tissue surrounding the hipPartial repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting. | Procedure or surgery | Partial Repairing of soft tissue surrounding the hip |
Primary outcome
Trendelenburg Test
Time frame: At 4 week postoperatively
30 seconds standing on the operated leg
Abductor strength
Time frame: At 4 week postoperatively
Dynamometry
3 secondary outcomes
WOMAC
Time frame: At 2, 4, 6 weeks and 12 months postoperatively
Quality of life (EQ-5D)
Time frame: At 2, 4, 6 weeks and 12 months postoperatively
Pain (Visual analouge scale)
Time frame: At 2, 4, 6 weeks and 12 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Neck Fracture, run by First Hospitals affiliated to the China PLA General Hospital.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Trendelenburg Test (time frame: At 4 week postoperatively). 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?
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 13 Sep 2016.