Distal Femur FracturesPhase 4NCT01693367
Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation
A Phase 4 study testing DLS 5.0 (Dynamic locking screws) and SLS (Standard locking screw) in people with Distal Femur Fractures, run by AO Innovation Translation Center at 12 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS). Read more about this study
- Who is it for?
- Ages 21 to 120 years
- Conditions the study is for
- Distal Femur Fractures
- What is being tested?
- DLS 5.0 (Dynamic locking screws) and SLS (Standard locking screw)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Sep 2012to Dec 2014
- Phase
- Phase 4
- 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 21 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years and older
- Closed or open distal femur fracture (AO 33 A1-3, 33 C1-3) including distal femur fractures above a total knee arthroplasty
- Ability to walk independently prior to injury
- Eligible for treatment with ORIF of the distal femur with a large fragment locking plate (LISS, LCP)
- Willing and able to comply with post-operative protocol and return for follow-up.
- Ability to understand the content of the patient information / informed consent form and participate in the clinical investigation
- Signed informed consent
Who cannot join
- Additional ipsi- or contralateral lower extremity fracture
- Any kind of implant at the ipsilateral proximal femur
- Pre-existing malunion or nonunion of the ipsilateral lower extremity
- Segmental bone defect requiring bone grafting
- More than 4 weeks between injury and surgery
- Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis)
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- Polytrauma
- Active malignancy
- Any not medically managed severe systemic disease
- Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
- Pregnancy or women planning to conceive within the study period
- Prisoner
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United States5 sites
University of Missouri Orthopaedics
Columbia, Missouri, 65212
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
UC Davis Medical Center
Sacramento, California, 95817
Harborview Medical Center
Seattle, Washington, 98104
Washington University Orthopedics
St Louis, Missouri, 63110
Germany3 sites
Charité Berlin, Campus Virchow Klinikum
Berlin, 13353
Universitätsklinikum des Saarlandes
Homburg, 66421
BGU Tübingen
Tübingen, 72076
Switzerland3 sites
Cantonal Hospital Chur
Chur, 7000
Luzerner Kantonsspital
Lucerne, 6000
Universitätsspital Zürich
Zurich, 8091
About this study
Official title: A Multi-Center Randomized Controlled Pilot Study of Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation
The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC score) due to increased and more symmetrical callus formation and fewer non-unions.
- Conditions
- Distal Femur Fractures
- Being tested
- DLS 5.0 (Dynamic locking screws), SLS (Standard locking screw)
- Keywords
- Femoral fracture, Periprosthetic fracture, Fracture fixation, internal, Distal femur fractures, Dynamic Locking Screw, WOMAC
- Medical subject headings
- Femoral Fractures, Distal, Femoral Fractures, Periprosthetic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLS 5.0 (Dynamic locking screws)Device
Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0
SLS (Standard locking screw)Device
Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)
| Study group | Role | What they receive |
|---|---|---|
| DLS 5.0 (Dynamic Locking Screws) | Active comparator | ORIF with DLS 5.0 (Dynamic Locking Screws) Receives: Device: DLS 5.0 (Dynamic locking screws) |
| SLS (Standard locking screw) | Active comparator | ORIF with SLS (Standard locking screw) Receives: Device: SLS (Standard locking screw) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Index (WOMAC)
To assess pain, stiffness, and physical function
Measured: 12 months after surgery
Secondary outcomes (5)
Timed Up-and-go Test (TUG)
The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seated position is reached again.
Measured: 12 weeks ± 7 days, 6 months ± 30 days
Quality of Life (EuroQol-5D)
Measured: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Range of Motion (ROM)
Assessment of passive ROM of the knee (flexion - extension)
Measured: 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Full Weight-bearing Status
Assessment of the timepoint when the patient :
- can bear the whole body weight on the affected leg at single-leg-stance for 3 seconds
- can walk without walking aid
- has no intake of analgesics
- has a pain level experienced at the fracture site during weight bearing over two consecutive measurements with a value of ≤ 3 as measured on a 0-10 numeric rating scale (NRS), where 0 = no pain and 10 = worst pain imaginable
Measured: weekly measurement at home
WOMAC
To assess pain, stiffness, and physical function
Measured: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: The medical device has been withdrawn from the market due to technical issues.
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 Distal Femur 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J. Gardner, MD, Principal investigator, Washington University School of MedicineSean E. Nork, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693367
- Sponsor's protocol ID
- DLS 5.0
- Status last verified
- Aug 2016
- First submitted
- 20 Sep 2012
- Last updated
- 13 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomized Controlled Pilot Study of Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation
- ClinicalTrials.gov ID
- NCT01693367
- Acronym / sponsor ID
- DLS 5.0
- Conditions
- Distal Femur Fractures
- Keywords
- Femoral fracture, Periprosthetic fracture, Fracture fixation, internal, Distal femur fractures, Dynamic Locking Screw, WOMAC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The medical device has been withdrawn from the market due to technical issues.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Posted 1 Jul 2016
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 the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC score) due to increased and more symmetrical callus formation and fewer non-unions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLS 5.0 (Dynamic Locking Screws) | Active comparator | Device: DLS 5.0 (Dynamic locking screws)ORIF with DLS 5.0 (Dynamic Locking Screws) |
| SLS (Standard locking screw) | Active comparator | Device: SLS (Standard locking screw)ORIF with SLS (Standard locking screw) |
Who may qualify
- Ages
- 21 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 21 years and older
- Closed or open distal femur fracture (AO 33 A1-3, 33 C1-3) including distal femur fractures above a total knee arthroplasty
- Ability to walk independently prior to injury
- Eligible for treatment with ORIF of the distal femur with a large fragment locking plate (LISS, LCP)
- Willing and able to comply with post-operative protocol and return for follow-up.
Key exclusion criteria (13 listed)
- Additional ipsi- or contralateral lower extremity fracture
- Any kind of implant at the ipsilateral proximal femur
- Pre-existing malunion or nonunion of the ipsilateral lower extremity
- Segmental bone defect requiring bone grafting
- More than 4 weeks between injury and surgery
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 |
|---|---|---|
| DLS 5.0 (Dynamic locking screws)Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0 | Device | DLS 5.0 (Dynamic Locking Screws) |
| SLS (Standard locking screw)Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw) | Device | SLS (Standard locking screw) |
Primary outcome
Western Ontario and McMaster Universities Index (WOMAC)
Time frame: 12 months after surgery
To assess pain, stiffness, and physical function
5 secondary outcomes
Timed Up-and-go Test (TUG)
Time frame: 12 weeks ± 7 days, 6 months ± 30 days
Quality of Life (EuroQol-5D)
Time frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Range of Motion (ROM)
Time frame: 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Full Weight-bearing Status
Time frame: weekly measurement at home
WOMAC
Time frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series
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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.
Michael J. Gardner, MD principal investigator
Washington University School of Medicine
Sean E. Nork, MD principal investigator
University of Washington
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DLS 5.0 (Dynamic locking screws) and SLS (Standard locking screw) in people with Distal Femur Fractures, run by AO Innovation Translation Center at 12 sites in 4 countries.
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 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 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Germany, Switzerland, Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2016). 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?
Western Ontario and McMaster Universities Index (WOMAC) (time frame: 12 months after 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 13 Aug 2020.