Sikkerhet og ytelse av MICRORAPTOR™ suturankre i skulder og hofte
Prospektiv multisenter post-markeds klinisk oppfølgingsstudie for å evaluere sikkerheten og ytelsen til MICRORAPTOR REGENESORB, Knotless REGENESORB og Knotless PEEK suturankre (og MINITAPE suturer) i skulder- og hofteartroskopisk ustabilitetsreparasjon
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Colorado
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Aurora, Colorado, Forente stater, 80045
- University of Colorado
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Colorado Springs, Colorado, Forente stater, 80920
- Colorado Springs Orthopaedic Group
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Florida
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Oakland Park, Florida, Forente stater, 33334
- Holy Cross Orthopedic Institute
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Georgia
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Brookhaven, Georgia, Forente stater, 30329
- Emory University - Brookhaven
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Maryland
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Annapolis, Maryland, Forente stater, 21401
- Luminis Health Research Institute
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Ohio
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Columbus, Ohio, Forente stater, 43202
- Ohio State University Wexner Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73114
- Oklahoma Sports and Science Orthopedics / The Physician's Group
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South Carolina
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Columbia, South Carolina, Forente stater, 29203
- Palmetto/Prisma Health - University of South Carolina Orthopaedics
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Greenville, South Carolina, Forente stater, 29615
- Steadman Hawkins Clinic of the Carolinas
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Virginia
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Virginia Beach, Virginia, Forente stater, 23452
- Atlantic Orthopaedic Specialists
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Woodbridge, Virginia, Forente stater, 22191
- Center for Advanced Orthopaedics / Nova Orthopedic & Spine Care
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Wisconsin
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Ashland, Wisconsin, Forente stater, 54806
- Memorial Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Personen krever gjenfesting av bløtvev til bein for følgende indikasjoner:
- Skulder - Kapselstabilisering for Bankart-reparasjon, fremre skulderinstabilitet, SLAP-lesjonsreparasjoner, kapselskift eller kapsulolabrale rekonstruksjoner, biceps tenodesis, rotatorcuff-reparasjoner (kun knuteløse ankre)
- Hofte - Acetabular labrum reparasjon/rekonstruksjon
Beskrivelse
Inklusjonskriterier:
Personen krever gjenfesting av bløtvev til bein for følgende indikasjoner:
- Skulder - Kapselstabilisering for Bankart-reparasjon, fremre skulderinstabilitet, SLAP-lesjonsreparasjoner, kapselskift eller kapsulolabrale rekonstruksjoner, biceps tenodesis, rotatorcuff-reparasjoner (kun knuteløse ankre)
- Hofte - Acetabular labrum reparasjon/rekonstruksjon
- Forsøkspersonen har samtykket til å delta i studien ved å signere det EC-godkjente informerte samtykkeskjemaet.
- Pasienten er ≥18 år på operasjonstidspunktet.
- Villig og i stand til å foreta alle nødvendige studiebesøk.
- Kunne følge instruksjoner.
Ekskluderingskriterier:
- Kjent overfølsomhet overfor implantatmaterialet. Der det er mistanke om materialsensitivitet, bør passende tester utføres og sensitivitet utelukkes før implantasjon.
- Patologiske tilstander i bein, som cystiske forandringer eller alvorlig osteopeni, som ville kompromittere sikker ankerfiksering.
- Patologiske forhold i bløtvevet som skal festes som vil svekke sikker fiksering ved sutur.
- Finmalt benoverflate, noe som ville kompromittere sikker ankerfiksering.
- Fysiske forhold som vil eliminere, eller har en tendens til å eliminere, tilstrekkelig ankerstøtte eller forsinke heling.
- Tilstedeværelsen av infeksjon.
- Forhold som vil begrense forsøkspersonens evne eller vilje til å begrense aktiviteter eller følge instruksjoner i løpet av helbredelsesperioden.
- Bruker for tiden tobakksprodukter (sigarett, røykfri tobakk, sigaretter, vaping etc.).
- Samtidig bilateral kirurgi.
- Tidligere implantasjon av MICRORAPTOR REGENESORB, MICRORAPTOR Knotless REGENESORB eller MICRORAPTOR Knotless PEEK.
- Deltakelse i behandlingsperioden til en annen klinisk studie innen tretti (30) dager etter besøk 1, eller under studien.
- Kvinner som er gravide eller ammer.
- Historie med dårlig etterlevelse av medisinsk behandling.
- Tidligere ipsilaterale operasjoner utført på leddrommet.
- Forsøkspersoner med en medisinsk eller fysisk tilstand som, etter etterforskerens oppfatning, ville utelukke sikker deltakelse i studien.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Annen
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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MICRORAPTOR™ REGENESORB™ suturanker
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Smith & Nephew MICRORAPTOR™ REGENESORB™ suturanker er en fikseringsanordning beregnet på å gi sikker festing av bløtvev til bein.
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MICRORAPTOR™ Knotless REGENESORB™ Suturanker
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MICRORAPTOR™ Knotless REGENESORB™ Suturanker er fikseringsanordning som består av et anker på en innstikker og en suturtreer.
Ankeret består av følgende komponenter: et proksimalt ankerlegeme (REGENESORB™), og en ikke-absorberbar PEEK (polyether ether keton) distal ankerspiss.
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MICRORAPTOR™ Knotless PEEK suturanker
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MICRORAPTOR™ Knotless PEEK suturanker er en klasse IIb-enhet, som består av et anker på en innstikker og en suturtreer.
Ankeret består av følgende komponenter: en proksimal ankerkropp (PEEK), og en ikke-absorberbar PEEK distal ankerspiss.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Mary Ozokwere, Smith & Nephew, Inc.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2018.20.SMD.MRPTKT.PRO
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