Femur FractureTHPNCT03870477
THP Hip Fracture Plating System Study
A study testing THP Hip Fracture Plating System with telescoping lag screws in people with Femur Fracture and Femur Fracture Intertrochanteric, run by Zimmer Biomet at 3 sites in United States.
Trial summary
The objective of this study is to systematically document the clinical outcomes of THP Hip Fracture Plating System when used to treat intracapsular and intertrochanteric fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femur Fracture, Femur Fracture Intertrochanteric, Garden Grade I Subcapital Fracture of Femoral Neck
- What is being tested?
- THP Hip Fracture Plating System with telescoping lag screws
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jan 2019to 10 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be 18 years of age or older.
- Patient must be eligible for an open reduction and internal fixation of the proximal femur.
- Patient must have an intracapsular or intertrochanteric fracture.
- Patient must have need for alignment, stabilization, and reduction of bone fractures.
- Patient must have ability and willingness to follow postoperative care instructions until healing is complete.
- Patient must be in good nutritional state.
- Patient must be able and willing to sign the IRB/EC approved informed consent.
Who cannot join
- Patient is a prisoner.
- Patient is a current alcohol or drug abuser.
- Patient is known to be pregnant or breastfeeding.
- Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent.
- Infection.
- Patient conditions including bloody supply limitations, obesity or insufficient quantity or quality of bone.
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- Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
- Patient has foreign body sensitivity. Where material sensitivity is suspected or unknown, testing is to be completed prior to implantation of the device.
- Patient is expected to be non-compliant with recommended post-operative weight-bearing instructions.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Eskenazi Health
Indianapolis, Indiana, 46202
About this study
Official title: Intracapsular and Intertrochanteric Fracture Fixation With the THP Hip Fracture Plating System
The objective of this study is to systematically document the clinical outcomes of THP Hip Fracture Plating System when used to treat intracapsular and intertrochanteric fractures.
Read the detailed description
Primary Endpoint:
- Revision rate due to device related complication(s) or non-union of the femur.
Secondary Endpoints:
- Radiographic and clinical fracture healing of the proximal femur using standard scoring methods.
- Conditions
- Femur Fracture, Femur Fracture Intertrochanteric, Garden Grade I Subcapital Fracture of Femoral Neck, Garden Grade II Subcapital Fracture of Femoral Neck, Garden Grade III Subcapital Fracture of Femoral Neck, Garden Grade IV Subcapital Fracture of Femoral Neck
- Being tested
- THP Hip Fracture Plating System with telescoping lag screws
- Keywords
- Cannulated Screws, Lag Screws, Compression Screws, Telescoping Lag Screws, Cortical Screws, Hip Fracture Plate
- Medical subject headings
- Femoral Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THP Hip Fracture Plating System with telescoping lag screwsDevice
The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments.
| Study group | Role | What they receive |
|---|---|---|
| THP Hip Fracture Plating System | Other | THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures Receives: Device: THP Hip Fracture Plating System with telescoping lag screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Revision
Revision rate due to device related complication(s) or non-union of the femur.
Measured: 6 weeks
Secondary outcomes (4)
Number of Participants With Radiographic Fracture Healing of the Femur (RUSH)
Radiographic fracture healing as seen on x-ray and defined using Radiographic Union Score for Hips (RUSH) scoring system. The RUSH quantifies four measures of healing: cortical bridging, cortical fracture disappearance, trabecular consolidation, and trabecular fracture disappearance. Cortical healing is assessed in four anatomic femoral neck regions (anterior, posterior, medial, lateral) and trabecular healing is measured with two assessments (fracture line disappearance and consolidation of matrix). Each of the 10 assessed dimensions of radiographic femoral neck healing are scored 1 to 3, leading to a minimum score of 10 (no signs of healing) and a maximum score of 30 (perfect healing).
Measured: 6 weeks
Average FIX-IT Score (Clinical Fracture Healing of the Femur)
The Function IndeX for Trauma (FIX-IT) score is an assessment tool for patients with lower extremity fractures, incorporating pain and the ability to weight-bear. The score utilizes two questions to assess the ability to bear weight and two questions to assess pain at the fracture site. The maximum subtotal for each set of questions is 6 points, yielding a maximum overall score of 12 points and a minimum score (lowest weight bearing and highest pain) of 0 points.
Measured: 6 weeks
Average EQ-5D-5L Score (Clinical Fracture Healing of the Femur)
The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death. The Health Status is scored on a VAS scale of 0 to 100, where 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine').
Measured: 6 weeks
Average VAS Pain Score
VAS pain scale is a unidimensional measure of pain intensity. The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start16 Jan 2019
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Why it stopped: Business decision to remove product from portfolio.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Boylan, MBA, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870477
- Sponsor's protocol ID
- CSU2017-22T
- Acronym
- THP
- Status last verified
- Apr 2022
- First submitted
- 8 Mar 2019
- Last updated
- 12 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracapsular and Intertrochanteric Fracture Fixation With the THP Hip Fracture Plating System
- ClinicalTrials.gov ID
- NCT03870477
- Acronym / sponsor ID
- THP / CSU2017-22T
- Conditions
- Femur Fracture, Femur Fracture Intertrochanteric, Garden Grade I Subcapital Fracture of Femoral Neck, Garden Grade II Subcapital Fracture of Femoral Neck, Garden Grade III Subcapital Fracture of Femoral Neck, Garden Grade IV Subcapital Fracture of Femoral Neck
- Keywords
- Cannulated Screws, Lag Screws, Compression Screws, Telescoping Lag Screws, Cortical Screws, Hip Fracture Plate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision to remove product from portfolio.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Posted 12 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to systematically document the clinical outcomes of THP Hip Fracture Plating System when used to treat intracapsular and intertrochanteric fractures.
Detailed description
Primary Endpoint:
- Revision rate due to device related complication(s) or non-union of the femur.
Secondary Endpoints:
- Radiographic and clinical fracture healing of the proximal femur using standard scoring methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THP Hip Fracture Plating System | Other | Device: THP Hip Fracture Plating System with telescoping lag screwsTHP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient must be 18 years of age or older.
- Patient must be eligible for an open reduction and internal fixation of the proximal femur.
- Patient must have an intracapsular or intertrochanteric fracture.
- Patient must have need for alignment, stabilization, and reduction of bone fractures.
- Patient must have ability and willingness to follow postoperative care instructions until healing is complete.
Key exclusion criteria (9 listed)
- Patient is a prisoner.
- Patient is a current alcohol or drug abuser.
- Patient is known to be pregnant or breastfeeding.
- Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent.
- Infection.
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 |
|---|---|---|
| THP Hip Fracture Plating System with telescoping lag screwsThe fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments. | Device | THP Hip Fracture Plating System |
Primary outcome
Number of Participants With a Revision
Time frame: 6 weeks
Revision rate due to device related complication(s) or non-union of the femur.
4 secondary outcomes
Number of Participants With Radiographic Fracture Healing of the Femur (RUSH)
Time frame: 6 weeks
Average FIX-IT Score (Clinical Fracture Healing of the Femur)
Time frame: 6 weeks
Average EQ-5D-5L Score (Clinical Fracture Healing of the Femur)
Time frame: 6 weeks
Average VAS Pain Score
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Ryan Boylan, MBA study director
Zimmer Biomet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THP Hip Fracture Plating System with telescoping lag screws in people with Femur Fracture and Femur Fracture Intertrochanteric, run by Zimmer Biomet at 3 sites in United States.
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 9 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 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 12 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With a Revision (time frame: 6 weeks). 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 12 May 2022.