Sikkerhed og ydeevne af MICRORAPTOR™ suturankre i skulder og hofte
Prospektiv multicenter post-markeds klinisk opfølgningsundersøgelse for at evaluere sikkerhed og ydeevne af MICRORAPTOR REGENESORB, Knotless REGENESORB og Knotless PEEK suturankre (og MINITAPE suturer) i skulder- og hofteartroskopisk ustabilitetsreparation
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado
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Colorado Springs, Colorado, Forenede Stater, 80920
- Colorado Springs Orthopaedic Group
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Florida
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Oakland Park, Florida, Forenede Stater, 33334
- Holy Cross Orthopedic Institute
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Georgia
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Brookhaven, Georgia, Forenede Stater, 30329
- Emory University - Brookhaven
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Maryland
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Annapolis, Maryland, Forenede Stater, 21401
- Luminis Health Research Institute
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Ohio
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Columbus, Ohio, Forenede Stater, 43202
- Ohio State University Wexner Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73114
- Oklahoma Sports and Science Orthopedics / The Physician's Group
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29203
- Palmetto/Prisma Health - University of South Carolina Orthopaedics
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Greenville, South Carolina, Forenede Stater, 29615
- Steadman Hawkins Clinic of the Carolinas
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Virginia
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Virginia Beach, Virginia, Forenede Stater, 23452
- Atlantic Orthopaedic Specialists
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Woodbridge, Virginia, Forenede Stater, 22191
- Center for Advanced Orthopaedics / Nova Orthopedic & Spine Care
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Wisconsin
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Ashland, Wisconsin, Forenede Stater, 54806
- Memorial Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Forsøgspersonen kræver genbinding af blødt væv til knogle til følgende indikationer:
- Skulder - Kapselstabilisering til Bankart-reparation, ustabilitet i forreste skulder, reparationer af SLAP-læsioner, kapselskift eller kapsulolabrale rekonstruktioner, Biceps-tenodese, reparation af rotatormanchet (kun knudeløse ankre)
- Hofte - Acetabulære labrum reparation/rekonstruktion
Beskrivelse
Inklusionskriterier:
Forsøgspersonen kræver genbinding af blødt væv til knogle til følgende indikationer:
- Skulder - Kapselstabilisering til Bankart-reparation, ustabilitet i forreste skulder, reparationer af SLAP-læsioner, kapselskift eller kapsulolabrale rekonstruktioner, Biceps-tenodese, reparation af rotatormanchet (kun knudeløse ankre)
- Hofte - Acetabulære labrum reparation/rekonstruktion
- Forsøgspersonen har givet samtykke til at deltage i undersøgelsen ved at underskrive den EC-godkendte informerede samtykkeformular.
- Forsøgspersonen er ≥18 år på operationstidspunktet.
- Villig og i stand til at aflægge alle nødvendige studiebesøg.
- Kan følge instruktionerne.
Ekskluderingskriterier:
- Kendt overfølsomhed over for implantatmaterialet. Hvis der er mistanke om materialefølsomhed, bør passende tests udføres og følsomhed udelukkes før implantation.
- Patologiske knogletilstande, såsom cystiske forandringer eller svær osteopeni, som ville kompromittere sikker ankerfiksering.
- Patologiske tilstande i det bløde væv, der skal fastgøres, som ville forringe sikker fiksering med sutur.
- Finmalet knogleoverflade, hvilket ville kompromittere sikker ankerfiksering.
- Fysiske tilstande, som ville eliminere eller har tendens til at eliminere tilstrækkelig ankerstøtte eller forsinke heling.
- Tilstedeværelsen af infektion.
- Tilstande, der ville begrænse forsøgspersonens evne eller vilje til at begrænse aktiviteter eller følge anvisninger under helingsperioden.
- Bruger i øjeblikket tobaksprodukter (cigaret, røgfri tobak, cigaretter, vaping osv.).
- Samtidig bilateral operation.
- Tidligere implantation af MICRORAPTOR REGENESORB, MICRORAPTOR Knotless REGENESORB eller MICRORAPTOR Knotless PEEK.
- Deltagelse i behandlingsperioden for et andet klinisk forsøg inden for tredive (30) dage efter besøg 1 eller under undersøgelsen.
- Kvinder, der er gravide eller ammer.
- Historie med dårlig overholdelse af medicinsk behandling.
- Tidligere ipsilaterale operationer udført på ledrummet.
- Forsøgspersoner med en medicinsk eller fysisk tilstand, der efter investigatorens mening ville udelukke sikker forsøgspersons deltagelse i undersøgelsen.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Andet
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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MICRORAPTOR™ REGENESORB™ Suturanker
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Smith & Nephew MICRORAPTOR™ REGENESORB™ suturanker er en fikseringsanordning beregnet til at give sikker fastgørelse af blødt væv til knogler.
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MICRORAPTOR™ Knudefri REGENESORB™ suturanker
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MICRORAPTOR™ Knotless REGENESORB™ Suturanker er fikseringsenhed, som består af et anker på en indsætter og en suturtråder.
Ankeret består af følgende komponenter: et proksimalt ankerlegeme (REGENESORB™) og en ikke-absorberbar PEEK (polyetheretherketon) distal ankerspids.
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MICRORAPTOR™ Knudefri PEEK suturanker
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MICRORAPTOR™ Knotless PEEK suturanker er en klasse IIb-enhed, som består af et anker på en indsætter og en suturtråder.
Ankeret består af følgende komponenter: et proksimalt ankerlegeme (PEEK) og en ikke-absorberbar PEEK distal ankerspids.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Repair Failure Rate at 6 Months
Tidsramme: 6 months
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Repair failure at 6 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain).
In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss.
The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 6-month follow-up.
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6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Repair Failure Rate at 12 Months
Tidsramme: 12 months
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Repair failure at 12 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain).
In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss.
The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 12-month follow-up.
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12 months
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Visual Analogue Scale (VAS) Pain Change From Baseline
Tidsramme: Baseline to 6 months, 12 months, and 24 months
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Pain was assessed using a Visual Analogue Scale (VAS) where participants indicated their pain level by marking a point that represented their perceived pain intensity.
Scores ranged from 0 to 100, with 0 representing no pain and 100 representing the worst imaginable pain (i.e., a worse outcome).
A decrease in VAS Pain score indicated a reduction in pain (i.e., a better outcome) and an increase indicated worsening in pain (i.e., a worse outcome).
The mean change in pain score was recorded on the VAS from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
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Baseline to 6 months, 12 months, and 24 months
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Repair Failure Rate at 24 Months (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY)
Tidsramme: 24 months
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Repair failure at 24 months was collected only for participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor.
Repair failure was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain).
In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss.
The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 24-month follow-up.
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24 months
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Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Acetabular Labral Condition
Tidsramme: Baseline, 6 months, and 24 months
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Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on acetabular labral condition classification. The number of participants acetabular labral condition was classified as one of the following:
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Baseline, 6 months, and 24 months
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Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Joint Effusion
Tidsramme: Baseline, 6 months, and 24 months
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Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on joint effusion classification. The number of participants joint effusion was classified as one of the following:
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Baseline, 6 months, and 24 months
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Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Bone Marrow Edema
Tidsramme: Baseline, 6 months, and 24 months
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Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on the presence of bone marrow edema.
The number of participants with bone marrow edema were categorized as 'Absent' or 'Present'.
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Baseline, 6 months, and 24 months
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Rowe Shoulder Score Change From Baseline (Shoulder Participants ONLY)
Tidsramme: Baseline to 6 months, 12 months, and 24 months
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The Rowe shoulder score for shoulder instability evaluated using a 3-item instrument completed by the investigator or qualified, delegated study staff. Its questions addressed the categories of shoulder stability (0 to 50 points), motion (0 to 20 points), and function (0 to 30 points). Scores ranged from 0 to 100 with a score of 90-100 points indicating an excellent evaluation, 75-89 points indicating a good evaluation, 51-74 points indicating a fair evaluation, and =< 50 points indicating a poor evaluation. An increase in Rowe score indicated reduced shoulder instability (i.e., a better outcome) and a decrease indicated worsening instability (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Western Ontario Shoulder Instability Index (WOSI) Score Change From Baseline (Shoulder Participants ONLY)
Tidsramme: Baseline to 6 months, 12 months, and 24 months
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Western Ontario Shoulder Instability Index (WOSI) was a participant completed instrument. Its categories included "physical symptoms", "sports, recreation, work", "pain", "lifestyle", and "emotion", with questions within each category scored from 0 to 100 using a visual analog scale. Scores were combined to produce an overall score that ranged from 0 to 2100 with a score of 0 indicating better shoulder function and 2100 indicating worse shoulder function. A decrease in WOSI score indicated improving shoulder function (i.e., a better outcome) and an increase indicated worsening shoulder function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Constant-Murley Shoulder Scale Change From Baseline (Should Participants ONLY)
Tidsramme: Baseline to 6 months, 12 months, and 24 months
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Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology: pain, activities of daily living (ADL), range of motion (ROM), and strength. The total score ranged from 0 to 100, with a higher score indicating better shoulder function. An increase in CMS score indicated improving shoulder function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Hip Outcome Score Activities of Daily Living (HOS-ADL) Score Change in Baseline (Hip Participants ONLY)
Tidsramme: Baseline to 6 months, 12 months, and 24 months
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The Hip Outcome Score Activities of Daily Living (HOS-ADL) subscale consisted of 17 items that addressed specific activities related to hip function. Scores ranged from 0 to 100 with 0 representing the least function and 100 representing the most function. An increase in HOS-ADL score indicated improved hip function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Modified Harris Hip Score (mHHS) Change From Baseline (Hip Participants ONLY)
Tidsramme: Baseline to 6 months, 12 months, and 24 months
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Modified Harris Hip Score (mHHS) is a joint specific score covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. Scores ranged from 0 to 100, with 0 representing worse disability and 100 representing less disability. An increase in mHHS indicated improved hip joint function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Mary Ozokwere, Smith & Nephew, Inc.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2018.20.SMD.MRPTKT.PRO
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