- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01667887
Plating of Distal Femur Fractures by Far Cortical Locking Using MotionLoc Screws
MotionLoc Study: Healing of Distal Femur Fractures Stabilized With a Flexible Plating Construct Using MotionLoc Screws
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Rigid locked plating constructs can suppress fracture healing, particularly at the near cortex adjacent to the plate where interfragmentary motion is minimal. Dynamic fixation with Far Cortical Locking (FCL) screws reduces construct stiffness and induces axial interfragmentary motion to stimulate symmetric callus formation and healing. Two versions of FCL screws are commercially available, but the clinical durability of this novel concept has not been documented to date. This prospective observational study documented our early clinical experience with MotionLoc® FCL screws for stabilization of distal femur fractures to assess their durability and potential complications.
Thirty-two consecutive patients with 33 distal femur fractures (AO/OTA types 33-A and 33-C) were prospectively enrolled at three trauma centers. Fractures were stabilized by plate osteosynthesis with MotionLoc® FCL screws without supplemental bone graft or bone morphogenic proteins. Thirty patients with 31 fractures were available for follow-up until union or revision. Follow-up visits at 6, 12, and 24 weeks comprised functional and radiographic assessment of implant fixation and fracture healing, including computed tomography scans at week 12. The primary endpoint was fracture healing in absence of complications and revision.
There was no incidence of implant breakage or diaphyseal fixation failure. Thirty of 31 fractures healed within 15.6 ± 6.2 weeks, as evident by bridging callus and pain-free load bearing. There were two revisions, one at 5 days post surgery to correct a mal-rotation, and one at 6 months post surgery to revise a non-union. Periosteal callus distribution at week 6 was symmetrical, with similar amounts of callus at the medial cortex (35%) anterior cortex (30%) and posterior cortex (35%). In 23 fractures (74%), callus formation extended to the lateral cortex under the plate.
Absence of hardware and fixation failure suggests that dynamic plating of distal femur fractures with FCL screws provides safe and effective fixation. Moreover, the amount and symmetric distribution of periosteal callus suggests that dynamic fixation with FCL screws may promote increased fracture healing over standard locked plating. However, this hypothesis on the stimulatory effect of dynamic fixation on fracture healing requires investigation in a future randomized control trial.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Oregon
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Portland, Oregon, Forenede Stater, 97232
- Legacy Health System
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients with distal femur fracture (AO/OTA Type 33A and 33C)
- Patients 17 years of age and over.
- Patients able to be operated on by selected surgeons at the participating centers.
Exclusion Criteria:
- Pregnancy
- Patients who are enrolled in an investigational treatment trial.
- Patients who are not expected to survive the follow-up period.
- Considered an inappropriate participant by the study physician.
- Revision surgery
- Patients currently incarcerated or awaiting incarceration.
- Severe spinal injury with neurological deficit resulting in paralysis.
- Fracture fixed more then 28 days after injury.
- Acute or chronic local or systemic infections
- Periprosthetic fractures
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Femur Fractures
Patients with Distal Femur Fractures
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Brudheling
Tidsramme: 6, 12 og 24 uger efter operationen
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Frakturheling defineres klinisk ved evnen til smertefri vægtbæring og radiografisk ved callusdannelse og brodannelse.
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6, 12 og 24 uger efter operationen
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Periosteal callus størrelse
Tidsramme: 6, 12, 24 uger efter operationen
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Periosteal callusstørrelse vurderes ved de anteriore, posteriore og mediale aspekter på røntgenbilleder ved hjælp af en valideret beregningsalgoritme.
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6, 12, 24 uger efter operationen
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Bridging Callus fra CT
Tidsramme: 12 uger efter operationen
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Tværsnitsbilledanalyse, understøttet af 3D-gengivelse, for at detektere knoglebrodannelse ved de anteriore, posteriore og laterale aspekter af lårbenet.
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12 uger efter operationen
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Fikseringsfejl
Tidsramme: 24 uger efter operationen
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Vurderet med hensyn til tab af tilpasning 12 og 24 uger efter operationen
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24 uger efter operationen
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Hardwarefejl
Tidsramme: 6, 12, 24 uger efter operationen
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Brud på skrue eller plade
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6, 12, 24 uger efter operationen
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Michael Bottlang, PhD, Legacy Biomechanics Laboratory
- Studiestol: Steven Madey, MD, Legacy Health System
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MotionLoc Screw
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Kliniske forsøg med Fracture of Distal Femur
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Marcus Van AarsenLawson Health Research InstituteAfsluttetPoint-of-care ultralyd, distal radiusfrakturCanada
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Töölö HospitalAfsluttetIkke forening af brud | Femur Distal FrakturFinland
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Charite University, Berlin, GermanyJena University Hospital; Beckman Coulter, Inc.; University Hospital Dresden og andre samarbejdspartnereRekrutteringLårhalsbrud | Lårskaftbrud | Skinnebensskaftbrud | Underarmsbrud | Brud ikke forening | Distalt skinnebensbrud | Brudheling | Femur Distal Fraktur | Proksimal skinnebensfraktur | Humerus skaftbrud | Long Bone Delayed-Union Fracture | Pertrochanterisk brud på lårbenetTyskland