Hip FracturesNCT02996383
Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures
A study testing Internal fixation and Cemented Hemiarthroplasty in people with Hip Fractures and Undisplaced Intracapsular Hip Fracture, run by Peterborough and Stamford Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
In England each year over 70,000 people fracture their hip. Most of these patients are elderly females with the fracture occurring after a simple trip or stumble. Approximately half of these fractures are classified from their relationship to the hip joint capsule as intracapsular. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Hip Fractures, Undisplaced Intracapsular Hip Fracture
- What is being tested?
- Internal fixation and Cemented Hemiarthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to Sep 2019
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted to Peterborough and Stamford Hospitals NHS Foundation Trust with an undisplaced intracapsular fracture will be considered for inclusion within the study. Patients who lack Capacity for example dementia who are unable to provide informed consent will be included if the assent of their next of kin or legal guardian can be obtained.
Who cannot join
- • patients who decline to participate or in whom consent or assent is not available
- patients admitted when MJP is not available to supervise treatment
- patients with pathological fractures from Paget's disease of bone secondary's from tumour
- patients with delayed presentation who would be treated conservatively
- patients considered unfit for either surgical procedure
- younger patients, aged less than 80 years who are independently mobile and very active will be excluded at treated by internal fixation (the risk of fracture healing complication for this group is less, whilst there is an increased risk of long term complications after arthroplasty
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Peterborough and Stamford Hospital NHS Foundation Trust
Peterborough, Cambs, PE36DA
Martyn J Parker, MD, 441733874000 ext. 4193, Martyn.Parker@pbh-tr.nhs.uk
About this study
In England each year over 70,000 people fracture their hip. Most of these patients are elderly females with the fracture occurring after a simple trip or stumble. Approximately half of these fractures are classified from their relationship to the hip joint capsule as intracapsular. These fractures are subdivided into those that are displaced and those that are undisplaced. The majority of displaced fractures are treated with a replacement arthroplasty. Current treatment for the undisplaced fractures is generally by internal fixation of the fracture using screws and a plate, although some centres prefer replacement arthroplasty.
A recent randomised study on patients from Norway with undisplaced intracapsular fractures treated with either internal fixation or arthroplasty has just reported reduced complications and re-operations for those patients treated with an arthroplasty. In addition functional results were marginally better for those patients treated with an arthroplasty. Current practice in the UK is generally to treat these fractures by internal fixation. This study aims to see if replacement arthroplasty can indeed lead to the advantages suggested from the Norwegian study.
Patients who satisfy the inclusion criteria and are willing to participate will be randomised to receive either reduction and internal fixation of the fracture with a screw and plate device or alternatively replacement of their femoral head with an artificial hip replacement (hemiarthroplasty). After surgery patients will receive the same treatment as normal and be discharge home when able, with follow-up review in the hip fracture clinic. Subsequent follow-up for the research project is by phone calls from a research nurse who is blinded to the type of treatment that the patient has received. There will be no additional investigations or out-patient follow-up visits for these patients in comparison to normal treatment protocols. Results of the study will ultimately be published in a medical journal.
- Being tested
- Internal fixation, Cemented Hemiarthroplasty
- Keywords
- arthroplasty
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal fixationDevice
Internal fixation of the fracture with a Targon FN implant (BBraun Ltd, Germany)
Cemented HemiarthroplastyDevice
Replacement of the femoral head with a cemented hemiarthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Cemented hemiarthroplasty | Active comparator | Treatment of the fracture by a replacement arthroplasty with a cemented CPT hemiarthroplasty (manafactured by Zimmer company, Warsaw IN, USA) inserted via an anteriolateral approach to the hip Receives: Device: Cemented Hemiarthroplasty |
| Internal fixation | Active comparator | Internal fixation of the fracture with a screw and plate device (Targon FN plate, Aesculap cooperation, Tuttingham, Germany) Receives: Device: Internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
regain of mobility using the Parker and Palmer mobility scale
Assessment is using the Parker and Palmer mobility score (Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br. 1993;75:797-8.)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peterborough and Stamford Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martyn J Parker, Peterborough and Stamford Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996383
- Sponsor's protocol ID
- R&D/2016/05
- Status last verified
- Dec 2016
- First submitted
- 10 Jun 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures
- ClinicalTrials.gov ID
- NCT02996383
- Acronym / sponsor ID
- R&D/2016/05
- Keywords
- arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peterborough and Stamford Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Sep 2019 (estimated)
- First posted
- 19 Dec 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.
In England each year over 70,000 people fracture their hip. Most of these patients are elderly females with the fracture occurring after a simple trip or stumble. Approximately half of these fractures are classified from their relationship to the hip joint capsule as intracapsular. These fractures are subdivided into those that are displaced and those that are undisplaced. The majority of displaced fractures are treated with a replacement arthroplasty. Current treatment for the undisplaced fractures is generally by internal fixation of the fracture using screws and a plate, although some centres prefer replacement arthroplasty.
A recent randomised study on patients from Norway with undisplaced intracapsular fractures treated with either internal fixation or arthroplasty has just reported reduced complications and re-operations for those patients treated with an arthroplasty. In addition functional results were marginally better for those patients treated with an arthroplasty. Current practice in the UK is generally to treat these fractures by internal fixation. This study aims to see if replacement arthroplasty can indeed lead to the advantages suggested from the Norwegian study.
Patients who satisfy the inclusion criteria and are willing to participate will be randomised to receive either reduction and internal fixation of the fracture with a screw and plate device or alternatively replacement of their femoral head with an artificial hip replacement (hemiarthroplasty). After surgery patients will receive the same treatment as normal and be discharge home when able, with follow-up review in the hip fracture clinic. Subsequent follow-up for the research project is by phone calls from a research nurse who is blinded to the type of treatment that the patient has received. There will be no additional investigations or out-patient follow-up visits for these patients in comparison to normal treatment protocols. Results of the study will ultimately be published in a medical journal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemented hemiarthroplasty | Active comparator | Device: Cemented HemiarthroplastyTreatment of the fracture by a replacement arthroplasty with a cemented CPT hemiarthroplasty (manafactured by Zimmer company, Warsaw IN, USA) inserted via an anteriolateral approach to the hip |
| Internal fixation | Active comparator | Device: Internal fixationInternal fixation of the fracture with a screw and plate device (Targon FN plate, Aesculap cooperation, Tuttingham, Germany) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to Peterborough and Stamford Hospitals NHS Foundation Trust with an undisplaced intracapsular fracture will be considered for inclusion within the study. Patients who lack Capacity for example dementia who are unable to provide informed consent will be included if the assent of their next of kin or legal guardian can be obtained.
Key exclusion criteria (6 listed)
- • patients who decline to participate or in whom consent or assent is not available
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 |
|---|---|---|
| Internal fixationInternal fixation of the fracture with a Targon FN implant (BBraun Ltd, Germany) | Device | Internal fixation |
| Cemented HemiarthroplastyReplacement of the femoral head with a cemented hemiarthroplasty | Device | Cemented hemiarthroplasty |
Primary outcome
regain of mobility using the Parker and Palmer mobility scale
Time frame: one year
Assessment is using the Parker and Palmer mobility score (Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br. 1993;75:797-8.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal fixation and Cemented Hemiarthroplasty in people with Hip Fractures and Undisplaced Intracapsular Hip Fracture, run by Peterborough and Stamford Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 6 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 19 Dec 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 United Kingdom. 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?
Contact martyn parker (441733678000, martyn.parker@pbh-tr.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
regain of mobility using the Parker and Palmer mobility scale (time frame: one year). 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 19 Dec 2016.