Hip FracturesNCT03065101
Trigen InterTAN vs Sliding Hip Screw RCT
A study testing Trigen Intertan, Post-Surgery Follow Up and Sliding Hip Screw in people with Hip Fractures, run by Smith & Nephew Orthopaedics AG at 5 sites in United Kingdom.
Trial summary
The purpose of this study is to compare the Trigen InterTAN Intramedullary nail to Sliding Hip Screws in AO/OTA 31-A1 and A2 intertrochanteric hip fractures. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Trigen Intertan, Post-Surgery Follow Up and Sliding Hip Screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 30 Sep 2017to 30 Sep 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- has closed trochanteric hip fracture (AO/OTA 31-A1 or A2) requiring treatment with internal fixation
- has injury due to low energy trauma
- is independently ambulatory in living environment prior to injury (walking aids permitted)
- is >60 years of age
- is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires
- has consented to participate in the study by signing the Ethics Committee (EC) approved ICF
- has definitive fracture fixation <72h from admission
Who cannot join
- has any additional injury or disability affecting mobility or affecting use of walking aids
- has a pathological fracture (excluding osteoporotic fracture)
- has an existing implant in study hip
- has diagnosis of an immunosuppressive disorder
- has an active infection, treated or untreated, systemic or at the site of the - has a condition that may interfere with the outcome of the study, including but not limited to: Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease
- has a BMI >40
Show all 12Show fewer
- has an inadequate bone stock to support the device which would make the procedure unjustifiable, including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia
- is pregnant or plans to become pregnant during the course of the study
- is a prisoner or is facing impending incarceration
- in the opinion of the PI, has an emotional or neurological condition that would interfere with their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse
- is entered in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days
- is known to be at risk for lost to follow-up, or failure to return for scheduled visits
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Royal Devon and Exeter Hospital
Exeter
Gloucestershire Royal Hospital
Gloucester
Royal Liverpool University Hospital
Liverpool, L7 8XP
Derriford Hospital
Plymouth
Royal Cornwall Hospital
Truro
About this study
Official title: Functional Advantages of TRIGEN™ INTERTAN™ Over Sliding Hip Screw in Subjects With Trochanteric Hip Fracture: A Randomised Controlled Trial
The purpose of this study is to compare the Trigen InterTAN Intramedullary nail to Sliding Hip Screws in AO/OTA 31-A1 and A2 intertrochanteric hip fractures.
Read the detailed description
A multicentre, randomised controlled trial, conducted in the UK will recruit 180 subjects, randomised to receive either the Trigen InterTAN Nail or the Sliding Hip Screw.
Subjects presenting at participating hospitals with AO/OTA 31-A1 or A2 fractures will be assessed against the eligibility criteria and approached for Informed Consent.
Subjects who are considered eligible and who have provided Informed Consent will be randomised using iDataFax to one of the two treatment options.
Subjects will be operated on according to standard procedure and the Instructions for Use.
A daily inpatient assessment will record the subjects use of opioid pain medication.
Subjects will be assessed at the time of discharge to record their residential and ambulatory status, Functional Independence Measure, Get Up and Go Test and opioid usage.
At 8 weeks and 12 weeks post surgery, subjects will be contacted by telephone to confirm their residential and ambulatory status, Functional Independence Measure, modified Harris Hip Score and Euroqol-5D.
At 6 months post surgery, subjects will attend an outpatient visit to have a follow up radiograph, Get Up and Go Test, residential and ambulatory status, Functional Independence Measure, modified Harris Hip Score and Euroqol-5D.
At 12 months post surgery, subjects will be contacted by telephone to confirm their residential and ambulatory status, Functional Independence Measure, modified Harris Hip Score and Euroqol-5D.
Adverse events, device deficiencies and reoperations will be recorded as and when they occur throughout the study.
- Conditions
- Hip Fractures
- Being tested
- Trigen Intertan, Post-Surgery Follow Up, Sliding Hip Screw
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigen IntertanDevice
While both the Trigen InterTAN and Sliding Hip Screw are marketed and demonstrated to be suitable for treatment of the study indication, the randomisation is considered an intervention as it may be contrary to the treatment chosen by the surgeon were the patient not a study subject.
Post-Surgery Follow UpOther
The current clinical trend is for minimal follow up post-surgery, unless indicated by complications. The study protocol indicated that follow up telephone visits are to be performed at 8 weeks, 12 weeks and 12 months post-surgery and an outpatient follow up visit at 6 months post-surgery. While most outcome measures are conducted via questionnaire, the increase in follow up means that subjects may be exposed to increased ionising radiation.
Sliding Hip ScrewDevice
Sliding Hip Screw
| Study group | Role | What they receive |
|---|---|---|
| Trigen Intertan | Other | * Unique integrated interlocking screw and trapezoidal nail shape
* Resistance to femoral head rotation and cut-out
* Active compression through linear motion without rotation
* Single subtrochanteric lag screw option for stable fractures below lesser trochanter
* Preloaded cannulated set screw converts construct to fixed angle device
* Small proximal diameter of the nail promotes preservation of the lateral wall of the greater trochanter and gluteus medius tendon
* Clothespin tip for stress modulation in femoral shaft
* Potential for improved patient mobility and recovery
Manufactured by Smith \& Nephew Inc., 1450 Brooks Road, Memphis, TN 38116, U.S.A.
Interventions:
Randomisation to either Trigen Intertan or Sliding Hip Screw, Post-Surgery Follow Up Receives: Device: Trigen Intertan; Other: Post-Surgery Follow Up |
| Sliding Hip Screw | Other | SHS is a generic term for a group of devices used for internal fixation of trochanteric hip fractures. Also known as Compression Hip Screw or Dynamic Hip Screw. All devices feature a lag screw inserted into the femoral neck and a side plate held in place by cortical screws inserted into the proximal femoral shaft.
Therapeutic effect is achieved by guided collapse, where the lag screw can slide in the barrel of the side plate which compresses the fracture as the patient begins to weight-bear.
Participating sites may use whichever brand of SHS is currently in use.
Interventions:
Randomisation to either Trigen Intertan or Sliding Hip Screw, Post-Surgery Follow Up Receives: Other: Post-Surgery Follow Up; Device: Sliding Hip Screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure (motor portion)
The FIM instrument is a basic indicator of severity of disability. Comprises 18 items assessed against a seven point ordinal scale, where the higher the score for an item, the more independently the patient is able to perform the tasks assessed by that item. Total scores range from 18 to 126. The items are divided into 13 Motor items and 5 Cognitive Items. The rating scale designates major graduations in behaviour from dependence to independence. The scale provides for the classification of individuals by their ability to carry out an activity independently, versus their need for assistance from another person or a device. If help is needed the scale assesses the degree of that need.
Patient reported outcome.
Measured: 8 weeks post-surgery
Secondary outcomes (8)
Functional Independence Measure
The FIM instrument is a basic indicator of severity of disability. Comprises 18 items assessed against a seven point ordinal scale, where the higher the score for an item, the more independently the patient is able to perform the tasks assessed by that item. Total scores range from 18 to 126. The items are divided into 13 Motor items and 5 Cognitive Items. The rating scale designates major graduations in behaviour from dependence to independence. The scale provides for the classification of individuals by their ability to carry out an activity independently, versus their need for assistance from another person or a device. If help is needed the scale assesses the degree of that need.
Patient reported outcome.
Measured: 12 weeks, 6 months and 12 months post-surgery
Get Up and Go Test
Requires the study subject to;
- Sit comfortably in a straight-backed chair
- Rise from the chair
- Stand still momentarily
- Walk a short distance (approximately 3 metres)
- Turn around
- Walk back to the chair
- Turn around
- Sit down in the chair Movements are observed for any deviation from a confident, normal performance and recorded as;
- Normal 2. Very slightly abnormal 3. Mildly abnormal 4. Moderately abnormal 5. Severely abnormal Subjects will be scored as above and whether any mobility aids were required. The GUG Test will be supervised and recorded by study staff.
Measured: Discharge (estimated 2 weeks post-surgery) and 6 months post-surgery
Residential Status Questionnaire
Pre-operatively it will be recorded what the subjects' residential status was prior to injury, whether they were;
- living at home independently
- living at home with additional care
- living in sheltered housing
- living in a care institution At discharge and thereafter it will be recorded which of these living environments the subject is discharged to with the additional option of;
- NHS rehabilitation
Measured: Pre-Op (Day prior to or day of surgery), Discharge (estimated 2 weeks post-surgery), 8 weeks, 12 weeks, 6 months and 12 months post-surgery
Ambulatory Status Questionnaire
Pre-operatively it will be recorded what the subjects' ambulatory status was prior to injury inside and outside their living environment, whether they were;
- Walking unaided
- Walking with aids
- 1 stick
- 2 sticks
- Frame
- Wheelchair (Note: Wheelchair use inside the living environment pre-operatively is an exclusion criterion. Wheelchair use outside the living environment is permitted if the subject is walking unaided or with stick(s) or frame inside the home) Ambulatory status will be recorded at discharge and at all Follow-Up timepoints thereafter.
Measured: Pre-Op (Day prior to or day of surgery), Discharge (estimated 2 weeks post-surgery), 8 weeks, 12 weeks, 6 months and 12 months post-surgery
Radiographic Assessment (calculation of medialisation, shortening and tip-apex distance)
A pre-operative low centred anteroposterior (AP) pelvis and lateral hip X-ray radiograph will be taken for diagnostic purposes. If a deformity is noted, a full length AP and lateral femur X-ray will be conducted in addition.
The post-operative low centre AP pelvis and lateral hip X-ray radiographic assessment will record;
- femoral shortening
- femoral shaft medialisation
- offset
- tip-apex distance If a long nail is used or if there are concerns over fixation, a full length AP and lateral femur X-ray will be conducted in addition.
Measured: Pre-Op (Day prior to or day of surgery), immediately post-op and 6 months post-surgery
Modified Harris Hip Score
The HHS was developed to assess the results of hip surgery, first described in 1969 . A modified version (mHHS) is used in this study which records the subjects' experience of pain (worth a maximum of 44 points) and activities of daily living and gait (worth a maximum of 47 points). A higher score is associated with a better outcome. Questions include pain experienced, the distance the subject can walk, ability to put on socks and shoes, ability to use public transportation, supports needed, limp, ability to use stairs and any problems in sitting. Deformity and range of motion measurements are excluded from the standard HHS in order to allow remote completion.
This assessment is recorded by a clinician onto the CRF via interview with the subject.
Measured: 8 weeks, 12 weeks, 6 months and 12 months post-surgery
EQ-5D
The EuroQol EQ-5D is a standardized instrument for use as a measurement of health outcome. It consists of a descriptive system with 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) which are each assigned three levels (no problems, some problems, extreme problems) and a Visual Analogue Scale where subjects indicate a numerical value from 0-100 where 0 is the worst imaginable health state and 100 is the best imaginable health state.
The EQ-5D is a patient reported outcome.
Measured: 8 weeks, 12 weeks, 6 months and 12 months post-surgery
Log of opioid medication administered
A daily assessment of opioid usage will be made including recording;
- For each adminstration;
- Drug
- Dose
- Route of administration
- Time of administration
Measured: Daily from day 1 post-surgery to discharge (estimated 2 weeks post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start30 Sep 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Why it stopped: Low recruitment
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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Mitchell, MBChB FRCS, Principal investigator, University Hospitals Bristol and Weston NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065101
- Sponsor's protocol ID
- 15-3031-01
- Status last verified
- Mar 2019
- First submitted
- 24 Mar 2016
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Advantages of TRIGEN™ INTERTAN™ Over Sliding Hip Screw in Subjects With Trochanteric Hip Fracture: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03065101
- Acronym / sponsor ID
- 15-3031-01
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 27 Feb 2017 (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.
The purpose of this study is to compare the Trigen InterTAN Intramedullary nail to Sliding Hip Screws in AO/OTA 31-A1 and A2 intertrochanteric hip fractures.
Detailed description
A multicentre, randomised controlled trial, conducted in the UK will recruit 180 subjects, randomised to receive either the Trigen InterTAN Nail or the Sliding Hip Screw.
Subjects presenting at participating hospitals with AO/OTA 31-A1 or A2 fractures will be assessed against the eligibility criteria and approached for Informed Consent.
Subjects who are considered eligible and who have provided Informed Consent will be randomised using iDataFax to one of the two treatment options.
Subjects will be operated on according to standard procedure and the Instructions for Use.
A daily inpatient assessment will record the subjects use of opioid pain medication.
Subjects will be assessed at the time of discharge to record their residential and ambulatory status, Functional Independence Measure, Get Up and Go Test and opioid usage.
At 8 weeks and 12 weeks post surgery, subjects will be contacted by telephone to confirm their residential and ambulatory status, Functional Independence Measure, modified Harris Hip Score and Euroqol-5D.
At 6 months post surgery, subjects will attend an outpatient visit to have a follow up radiograph, Get Up and Go Test, residential and ambulatory status, Functional Independence Measure, modified Harris Hip Score and Euroqol-5D.
At 12 months post surgery, subjects will be contacted by telephone to confirm their residential and ambulatory status, Functional Independence Measure, modified Harris Hip Score and Euroqol-5D.
Adverse events, device deficiencies and reoperations will be recorded as and when they occur throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trigen Intertan | Other | Device: Trigen Intertan, Other: Post-Surgery Follow Up* Unique integrated interlocking screw and trapezoidal nail shape * Resistance to femoral head rotation and cut-out * Active compression through linear motion without rotation * Single subtrochanteric lag screw option for stable fractures below lesser trochanter * Preloaded cannulated set screw converts construct to fixed angle device * Small proximal diameter of the nail promotes preservation of the lateral wall of the greater trochanter and gluteus medius tendon * Clothespin tip for stress modulation in femoral shaft * Potential for improved patient mobility and recovery Manufactured by Smith \& Nephew Inc., 1450 Brooks Road, Memphis, TN 38116, U.S.A. Interventions: Randomisation to either Trigen Intertan or Sliding Hip Screw, Post-Surgery Follow Up |
| Sliding Hip Screw | Other | Other: Post-Surgery Follow Up, Device: Sliding Hip ScrewSHS is a generic term for a group of devices used for internal fixation of trochanteric hip fractures. Also known as Compression Hip Screw or Dynamic Hip Screw. All devices feature a lag screw inserted into the femoral neck and a side plate held in place by cortical screws inserted into the proximal femoral shaft. Therapeutic effect is achieved by guided collapse, where the lag screw can slide in the barrel of the side plate which compresses the fracture as the patient begins to weight-bear. Participating sites may use whichever brand of SHS is currently in use. Interventions: Randomisation to either Trigen Intertan or Sliding Hip Screw, Post-Surgery Follow Up |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- has closed trochanteric hip fracture (AO/OTA 31-A1 or A2) requiring treatment with internal fixation
- has injury due to low energy trauma
- is independently ambulatory in living environment prior to injury (walking aids permitted)
- is >60 years of age
- is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires
Key exclusion criteria (12 listed)
- has any additional injury or disability affecting mobility or affecting use of walking aids
- has a pathological fracture (excluding osteoporotic fracture)
- has an existing implant in study hip
- has diagnosis of an immunosuppressive disorder
- has an active infection, treated or untreated, systemic or at the site of the - has a condition that may interfere with the outcome of the study, including but not limited to: Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease
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 |
|---|---|---|
| Trigen IntertanWhile both the Trigen InterTAN and Sliding Hip Screw are marketed and demonstrated to be suitable for treatment of the study indication, the randomisation is considered an intervention as it may be contrary to the treatment chosen by the surgeon were the patient not a study subject. | Device | Trigen Intertan |
| Post-Surgery Follow UpThe current clinical trend is for minimal follow up post-surgery, unless indicated by complications. The study protocol indicated that follow up telephone visits are to be performed at 8 weeks, 12 weeks and 12 months post-surgery and an outpatient follow up visit at 6 months post-surgery. While most outcome measures are conducted via questionnaire, the increase in follow up means that subjects may be exposed to increased ionising radiation. | Other | Sliding Hip Screw, Trigen Intertan |
| Sliding Hip ScrewSliding Hip Screw | Device | Sliding Hip Screw |
Primary outcome
Functional Independence Measure (motor portion)
Time frame: 8 weeks post-surgery
The FIM instrument is a basic indicator of severity of disability. Comprises 18 items assessed against a seven point ordinal scale, where the higher the score for an item, the more independently the patient is able to perform the tasks assessed by that item. Total scores range from 18 to 126. The items are divided into 13 Motor items and 5 Cognitive Items. The rating scale designates major graduations in behaviour from dependence to independence. The scale provides for the classification of individuals by their ability to carry out an activity independently, versus their need for assistance from another person or a device. If help is needed the scale assesses the degree of that need. Patient reported outcome.
8 secondary outcomes
Functional Independence Measure
Time frame: 12 weeks, 6 months and 12 months post-surgery
Get Up and Go Test
Time frame: Discharge (estimated 2 weeks post-surgery) and 6 months post-surgery
Residential Status Questionnaire
Time frame: Pre-Op (Day prior to or day of surgery), Discharge (estimated 2 weeks post-surgery), 8 weeks, 12 weeks, 6 months and 12 months post-surgery
Ambulatory Status Questionnaire
Time frame: Pre-Op (Day prior to or day of surgery), Discharge (estimated 2 weeks post-surgery), 8 weeks, 12 weeks, 6 months and 12 months post-surgery
Radiographic Assessment (calculation of medialisation, shortening and tip-apex distance)
Time frame: Pre-Op (Day prior to or day of surgery), immediately post-op and 6 months post-surgery
Modified Harris Hip Score
Time frame: 8 weeks, 12 weeks, 6 months and 12 months post-surgery
EQ-5D
Time frame: 8 weeks, 12 weeks, 6 months and 12 months post-surgery
Log of opioid medication administered
Time frame: Daily from day 1 post-surgery to discharge (estimated 2 weeks post-surgery)
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- 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.
Stephen Mitchell, MBChB FRCS principal investigator
University Hospitals Bristol and Weston NHS Foundation Trust
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trigen Intertan, Post-Surgery Follow Up and Sliding Hip Screw in people with Hip Fractures, run by Smith & Nephew Orthopaedics AG at 5 sites 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study was stopped early (reason given: Low recruitment). 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?
Functional Independence Measure (motor portion) (time frame: 8 weeks post-surgery). 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 29 Mar 2019.