Hip FracturesCHANCENCT02247791
Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty
A study testing Uncemented femoral stem and Cemented femoral stem in people with Hip Fractures, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a displaced femoral neck fracture. Read more about this study
- Who is it for?
- Ages 65 to 79 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Uncemented femoral stem and Cemented femoral stem
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2009to Sep 2024
- 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 65 to 79 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Acute Displaced femoral neck fracture
- Subject is aged between 65-79 years
- Independent walker with or without walking aides
- Subject is able and capable of providing consent to participate in the study
Who cannot join
- Patients with Rheumatoid Arthritis
- Patients with an impaired cognitive dysfunction
- Patients with Pathological fractures
- Patients with substance abuse
- Patients with fracture older than 36-hours on arrival at the A\&E
- Patients suffering from cancer
- Patients determined by principal investigator to be unsuitable for inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Prosthesis Choice in Older Patients With a Dislocated Femoral Neck Fracture of the Hip
The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a displaced femoral neck fracture.
Read the detailed description
The study will randomize patients between an uncemented and cemented stem
- Conditions
- Hip Fractures
- Being tested
- Uncemented femoral stem, Cemented femoral stem
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uncemented femoral stemProcedure or surgery
Also called BiMetric uncemented femoral stem
All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem
Cemented femoral stemProcedure or surgery
Also called CPT cemented femoral stem
All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem
| Study group | Role | What they receive |
|---|---|---|
| Cemented femoral stem | Active comparator | Patient undergoing total hip arthroplasty surgery Receives: Procedure: Cemented femoral stem |
| Uncemented femoral stem | Active comparator | Patients undergoing total hip arthroplasty Receives: Procedure: Uncemented femoral stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip related complication rate
All hip-related complications
Measured: 2 years
Health-related Quality of Life
Health related quality of life
Measured: 2 years
Secondary outcomes (3)
Duration of surgery
Measured: 2 years
Intraoperative bleeding
Measured: 2 years
Hip function
Measured with Harris hip score
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2009
- Primary completionSep 2016 (estimated)
- Study completionSep 2024 (estimated)
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 Hip 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, Olof Skoldenberg, Danderyd Hospital
- Investigators
- Ghazi Chammout, MD, Principal investigator, Dept of Orthopaedics, Danderyd Hospital, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247791
- Sponsor's protocol ID
- CHANCE
- Acronym
- CHANCE
- Status last verified
- Jan 2016
- First submitted
- 21 Oct 2013
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Chammout G, Muren O, Boden H, Salemyr M, Skoldenberg O. Cemented compared to uncemented femoral stems in total hip replacement for displaced femoral neck fractures in the elderly: study protocol for a single-blinded, randomized controlled trial (CHANCE-trial). BMC Musculoskelet Disord. 2016 Sep 20;17(1):398. doi: 10.1186/s12891-016-1253-y.
PubMed 27646142
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prosthesis Choice in Older Patients With a Dislocated Femoral Neck Fracture of the Hip
- ClinicalTrials.gov ID
- NCT02247791
- Acronym / sponsor ID
- CHANCE / CHANCE
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Sep 2009
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 25 Sep 2014 (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.
The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a displaced femoral neck fracture.
Detailed description
The study will randomize patients between an uncemented and cemented stem
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemented femoral stem | Active comparator | Procedure: Cemented femoral stemPatient undergoing total hip arthroplasty surgery |
| Uncemented femoral stem | Active comparator | Procedure: Uncemented femoral stemPatients undergoing total hip arthroplasty |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Acute Displaced femoral neck fracture
- Subject is aged between 65-79 years
- Independent walker with or without walking aides
- Subject is able and capable of providing consent to participate in the study
Key exclusion criteria (7 listed)
- Patients with Rheumatoid Arthritis
- Patients with an impaired cognitive dysfunction
- Patients with Pathological fractures
- Patients with substance abuse
- Patients with fracture older than 36-hours on arrival at the A\&E
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 |
|---|---|---|
| Uncemented femoral stemAlso: BiMetric uncemented femoral stemAll patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem | Procedure or surgery | Uncemented femoral stem |
| Cemented femoral stemAlso: CPT cemented femoral stemAll patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem | Procedure or surgery | Cemented femoral stem |
Primary outcome
Hip related complication rate
Time frame: 2 years
All hip-related complications
Health-related Quality of Life
Time frame: 2 years
Health related quality of life
3 secondary outcomes
Duration of surgery
Time frame: 2 years
Intraoperative bleeding
Time frame: 2 years
Hip function
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Derived from this study: PubMed 27646142Chammout G, Muren O, Boden H, Salemyr M, Skoldenberg O. Cemented compared to uncemented femoral stems in total hip replacement for displaced femoral neck fractures in the elderly: study protocol for a single-blinded, randomized controlled trial (CHANCE-trial). BMC Musculoskelet Disord. 2016 Sep 20;17(1):398. doi: 10.1186/s12891-016-1253-y.
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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.
Ghazi Chammout, MD principal investigator
Dept of Orthopaedics, Danderyd Hospital, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uncemented femoral stem and Cemented femoral stem in people with Hip Fractures, run by Danderyd 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 4 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: status not confirmed, as of the sponsor's last update on 28 Jan 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?
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?
Hip related complication rate (time frame: 2 years). 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 NCT02247791, 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 28 Jan 2016.