Intracapsular Proximal Femur FractureN-ForceNCT03807349
N-Force Screws Augmented With N-Force Blue in Hip Fractures
A study testing N-Force Screws Augmented with N-Force Blue in people with Intracapsular Proximal Femur Fracture and Garden Grade I Subcapital Fracture of Femoral Neck, run by Zimmer Biomet at 4 sites in United States.
Trial summary
The objective of this prospective study is to confirm safety and performance of N-Force Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture treatment. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Intracapsular Proximal Femur Fracture, Garden Grade I Subcapital Fracture of Femoral Neck, Garden Grade II Subcapital Fracture of Femoral Neck
- What is being tested?
- N-Force Screws Augmented with N-Force Blue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Feb 2019to 11 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has primary Garden I or II intracapsular proximal femur fracture requiring surgical intervention and is eligible for fixation by three cannulated screws augmented with N-Force Blue.
- Patient receives operative treatment within 7 days of injury.
- Patient was ambulatory before injury.
- Patient is 50 years of age or older.
Who cannot join
- Patient has Garden III or IV intracapsular proximal femur fracture.
- Patient has major cognitive impairment (including dementia).
- Patient is on dialysis.
- Patient is not expected to survive follow-up schedule.
- Patient is expected to have problems maintaining follow-up compliance, i.e. patients with no fixed address, patients not mentally competent to give informed consent, etc. (Investigator's discretion).
- Patient is a prisoner.
Show all 13Show fewer
- Patient is known to be pregnant and/or breastfeeding.
- Patient is a known alcohol or drug abuser.
- Patient had previous/has active acute or chronic infections, especially at the site of operation.
- Patient has non-viable bone, or has areas where surrounding bone is not viable or capable of supporting and anchoring the implant.
- Patient has traumatic injuries with open wounds or close to the proximal femur fracture, which are likely to become infected.
- Patient is expected to be non-compliant with recommended post-operative weight-bearing instructions.
- Physical conditions, in the opinion of the investigator, that would prohibit adequate implant support or impede healing.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Donald B Slocum Research and Education Foundation
Eugene, Oregon, 97401
University of Utah
Salt Lake City, Utah, 84108
Washington University
St Louis, Missouri, 63130
Stanford University
Stanford, California, 94305
About this study
Official title: N-Force Screws Augmented With N-Force Blue in Intracapsular Proximal Femur Fracture Treatment
The objective of this prospective study is to confirm safety and performance of N-Force Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture treatment.
Read the detailed description
Primary Endpoint:
- Re-operation within 12 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.
Secondary Endpoints:
- Radiographic and clinical fracture healing of the proximal femur using standard scoring methods and patient satisfaction.
- Cost effectiveness
- Conditions
- Intracapsular Proximal Femur Fracture, Garden Grade I Subcapital Fracture of Femoral Neck, Garden Grade II Subcapital Fracture of Femoral Neck
- Being tested
- N-Force Screws Augmented with N-Force Blue
- Keywords
- Cannulated Screws, Augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Force Screws Augmented with N-Force BlueDevice
N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)
| Study group | Role | What they receive |
|---|---|---|
| N-Force Screws | Other | N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures. Receives: Device: N-Force Screws Augmented with N-Force Blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Reoperation
Reoperation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.
Measured: 12 months
Secondary outcomes (8)
Number of Participants With Radiographic Fracture Healing of the Intracapsular 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, 3 months, 6 months, and 12 months
Participant Steinberg Classification at 12 Months
Steinberg Classification is based on the radiographic appearance and location of lesion. It is concise and delineates the progression and extent of Avascular Necrosis (AVN) involvement more accurately.
[stage 0:] normal or non-diagnostic radiographs, MRI and bone scan of at risk hip (often contralateral hip involved, or patient has risk factors and hip pain) [stage I:] normal radiograph, abnormal bone scan and/or MRI [stage II:] cystic and sclerotic radiographic changes [stage III:] subchondral lucency or crescent sign [stage IV:] flattening of femoral head, with depression graded into mild: <2 mm moderate: 2-4 mm severe: >4 mm [stage V:] joint space narrowing with or without acetabular involvement [stage VI]: advanced degenerative changes
Measured: 12 months
Average FIX-IT Score (Clinical Fracture Healing of the Intracapsular 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, 3 months, 6 months, and 12 months
Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular 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, 3 months, 6 months, and 12 months
Average Harris Hips Score (Clinical Fracture Healing of the Intracapsular Femur)
This will be measured using Harris Hip Score. This is quantified on a scale of 0-100 and the domains covered are pain, function, absence of deformity, and range of motion. The score is quantified on a scale of 0-100, with 100 points being the best possible outcome. The domains cover pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
Measured: 6 weeks, 3 months, 6 months, and 12 months
Number of Participants That Performed Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)
This will be measured using the Timed 'Up-and-Go' Test. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.This test is used to assess a person's mobility and requires both static and dynamic balance. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.
Measured: 6 weeks, 3 months, 6 months, and 12 months
Average Participant Time to Complete Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)
This will be measured using the Timed 'Up-and-Go' Test. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.This test is used to assess a person's mobility and requires both static and dynamic balance. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.
Measured: 6 weeks, 3 months, 6 months, and 12 months
Cost-Effective Analysis
Analysis will be performed comparing N-Force to standard non-augmented cannulated screws.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start21 Feb 2019
- Primary completion11 Mar 2021
- Study completion11 Mar 2021
Why it stopped: Sponsor will not pursue CE mark for this product, which precludes need for large PMCF study.
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 Intracapsular Proximal 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
- 12 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
- NCT03807349
- Sponsor's protocol ID
- CMU2017-60T
- Acronym
- N-Force
- Status last verified
- May 2022
- First submitted
- 8 Jan 2019
- Last updated
- 8 Jun 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 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-Force Screws Augmented With N-Force Blue in Intracapsular Proximal Femur Fracture Treatment
- ClinicalTrials.gov ID
- NCT03807349
- Acronym / sponsor ID
- N-Force / CMU2017-60T
- Conditions
- Intracapsular Proximal Femur Fracture, Garden Grade I Subcapital Fracture of Femoral Neck, Garden Grade II Subcapital Fracture of Femoral Neck
- Keywords
- Cannulated Screws, Augmentation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor will not pursue CE mark for this product, which precludes need for large PMCF study.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Posted 8 Jun 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 prospective study is to confirm safety and performance of N-Force Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture treatment.
Detailed description
Primary Endpoint:
- Re-operation within 12 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.
Secondary Endpoints:
- Radiographic and clinical fracture healing of the proximal femur using standard scoring methods and patient satisfaction.
- Cost effectiveness
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N-Force Screws | Other | Device: N-Force Screws Augmented with N-Force BlueN-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has primary Garden I or II intracapsular proximal femur fracture requiring surgical intervention and is eligible for fixation by three cannulated screws augmented with N-Force Blue.
- Patient receives operative treatment within 7 days of injury.
- Patient was ambulatory before injury.
- Patient is 50 years of age or older.
Key exclusion criteria (13 listed)
- Patient has Garden III or IV intracapsular proximal femur fracture.
- Patient has major cognitive impairment (including dementia).
- Patient is on dialysis.
- Patient is not expected to survive follow-up schedule.
- Patient is expected to have problems maintaining follow-up compliance, i.e. patients with no fixed address, patients not mentally competent to give informed consent, etc. (Investigator's discretion).
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 |
|---|---|---|
| N-Force Screws Augmented with N-Force BlueN-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material) | Device | N-Force Screws |
Primary outcome
Number of Participants With a Reoperation
Time frame: 12 months
Reoperation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.
8 secondary outcomes
Number of Participants With Radiographic Fracture Healing of the Intracapsular Femur (RUSH)
Time frame: 6 weeks, 3 months, 6 months, and 12 months
Participant Steinberg Classification at 12 Months
Time frame: 12 months
Average FIX-IT Score (Clinical Fracture Healing of the Intracapsular Femur)
Time frame: 6 weeks, 3 months, 6 months, and 12 months
Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur)
Time frame: 6 weeks, 3 months, 6 months, and 12 months
Average Harris Hips Score (Clinical Fracture Healing of the Intracapsular Femur)
Time frame: 6 weeks, 3 months, 6 months, and 12 months
Number of Participants That Performed Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)
Time frame: 6 weeks, 3 months, 6 months, and 12 months
Average Participant Time to Complete Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)
Time frame: 6 weeks, 3 months, 6 months, and 12 months
Cost-Effective Analysis
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-Force Screws Augmented with N-Force Blue in people with Intracapsular Proximal Femur Fracture and Garden Grade I Subcapital Fracture of Femoral Neck, run by Zimmer Biomet at 4 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 4 inclusion and 13 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 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 8 Jun 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 Reoperation (time frame: 12 months). 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 8 Jun 2022.