Femoral Neck FractureNCT01644227
Dual Mobility Cup in Total Hip Arthroplasty Preventing Dislocation in Patients at Risk
An observational study of Femoral Neck Fracture and Osteoarthritis, run by Sundsvall Hospital at 1 site in Sweden.
Trial summary
Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip arthroplasty between January 2009 and June 2012 at Sundsvall Hospital. Hypothesis: The dual mobility socket reduce the rate of dislocation in patient at high risk but increase the incidence of postoperative infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Femoral Neck Fracture, Osteoarthritis
- How many people
- 34 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2012to Jul 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients operated with an cemented dual mobility cups at Sundsvall hospital between 2009-2012. Indications for surgery are recurrent dislocation and patients at risk for dislocation mainly due to comorbidity, neuromuscular, psychiatric or cognitive disorders.
Who may be able to join
- operated with an cemented dual mobility socket at Sundsvall hospital
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip arthroplasty between January 2009 and June 2012 at Sundsvall Hospital.
Hypothesis: The dual mobility socket reduce the rate of dislocation in patient at high risk but increase the incidence of postoperative infection.
Read the detailed description
Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip arthroplasty between January 2009 and June 2012 at Sundsvall Hospital.
Indications for surgery is recurrent dislocation or patients at risk for dislocation after total hip arthroplasty suffering osteoarthritis or femoral neck fracture.
Patients are followed recording complications, reoperations, functional outcome (Harris hip score and EQ5D) in june 2012.
- Conditions
- Femoral Neck Fracture, Osteoarthritis
- Keywords
- Hip surgery, dual mobility cup, dislocation, total hip arthroplasty
- Medical subject headings
- Femoral Neck Fractures, Osteoarthritis, Joint Dislocations
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic dislocation
Incidence of postoperative dislocations of the prosthesis
Measured: 2012 (up to 3 years postoperatively)
Secondary outcomes (3)
Complication
Incidence of complications and reoperations
Measured: 2012 (up to 3 years postoperatively)
Hip function
Patient reported hip function; Harris hip score
Measured: 2012 (up to 3 years postoperatively)
Quality of life
Patient reported quality of life: EQ5D
Measured: 2012 (up to 3 years postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2012
- Study completionJul 2012
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 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
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sundsvall Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arkan S Sayed Noor, MD, PhD, Principal investigator, Landstinget Västernorrland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644227
- Sponsor's protocol ID
- Sebastian-1
- Status last verified
- Oct 2015
- First submitted
- 24 Jun 2012
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mukka SS, Mahmood SS, Sjoden GO, Sayed-Noor AS. Dual mobility cups for preventing early hip arthroplasty dislocation in patients at risk: experience in a county hospital. Orthop Rev (Pavia). 2013 Jun 11;5(2):48-51. doi: 10.4081/or.2013.e10. Print 2013 Jun 7.
PubMed 23888200
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Mobility Cup in Total Hip Arthroplasty Preventing Dislocation in Patients at Risk
- ClinicalTrials.gov ID
- NCT01644227
- Acronym / sponsor ID
- Sebastian-1
- Conditions
- Femoral Neck Fracture, Osteoarthritis
- Keywords
- Hip surgery, dual mobility cup, dislocation, total hip arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sundsvall HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 19 Jul 2012 (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.
Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip arthroplasty between January 2009 and June 2012 at Sundsvall Hospital.
Hypothesis: The dual mobility socket reduce the rate of dislocation in patient at high risk but increase the incidence of postoperative infection.
Detailed description
Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip arthroplasty between January 2009 and June 2012 at Sundsvall Hospital.
Indications for surgery is recurrent dislocation or patients at risk for dislocation after total hip arthroplasty suffering osteoarthritis or femoral neck fracture.
Patients are followed recording complications, reoperations, functional outcome (Harris hip score and EQ5D) in june 2012.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients operated with an cemented dual mobility cups at Sundsvall hospital between 2009-2012. Indications for surgery are recurrent dislocation and patients at risk for dislocation mainly due to comorbidity, neuromuscular, psychiatric or cognitive disorders.
Key inclusion criteria (1 listed)
- operated with an cemented dual mobility socket at Sundsvall hospital
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prosthetic dislocation
Time frame: 2012 (up to 3 years postoperatively)
Incidence of postoperative dislocations of the prosthesis
3 secondary outcomes
Complication
Time frame: 2012 (up to 3 years postoperatively)
Hip function
Time frame: 2012 (up to 3 years postoperatively)
Quality of life
Time frame: 2012 (up to 3 years 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 13 May 2016.
- Results publication: PubMed 23888200Mukka SS, Mahmood SS, Sjoden GO, Sayed-Noor AS. Dual mobility cups for preventing early hip arthroplasty dislocation in patients at risk: experience in a county hospital. Orthop Rev (Pavia). 2013 Jun 11;5(2):48-51. doi: 10.4081/or.2013.e10. Print 2013 Jun 7.
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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.
Arkan S Sayed Noor, MD, PhD principal investigator
Landstinget Västernorrland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Neck Fracture and Osteoarthritis, run by Sundsvall Hospital 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 0 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 13 May 2016. 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?
Prosthetic dislocation (time frame: 2012 (up to 3 years postoperatively)). 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 NCT01644227, 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 13 May 2016.