Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Sling vs. Dynamic Shoulder Stabilizer After Soft Tissue Shoulder Instability Surgery (SLIDY) (SLIDY)

15. juni 2026 oppdatert av: Abdul-ilah Hachem, Hospital Universitari de Bellvitge

Sling vs. Dynamic Shoulder Stabilizer After Soft Tissue Shoulder Instability Surgery ("SLIDY"): A Pilot Randomized Controlled Trial Assessing Feasibility, Early Functional Recovery, and Structural Healing

This randomized controlled trial seeks to address a significant clinical gap by evaluating the outcomes of two postoperative immobilization methods following arthroscopic soft tissue surgery for anterior shoulder instability: a standard static arm sling and a dynamic shoulder orthosis.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The present study is a pilot trial that aims to compare outcomes between patients immobilized using a standard arm sling and those managed with a dynamic shoulder orthosis (specifically, the medi® Shoulder action brace) following arthroscopic soft tissue stabilization for anterior shoulder instability. This trial will evaluate the impact of these two immobilization methods on early shoulder function, pain, recurrence, and patient satisfaction, while primarily assessing the feasibility of a future definitive trial. This is a prospective, single-center, pilot randomized controlled trial with parallel groups. Participants will be allocated in a 1:1 ratio to either the dynamic orthosis or the standard sling. The trial seeks to determine whether dynamic immobilization designed to facilitate controlled activity offers measurable advantages in early function, comfort, or recurrence risk compared to standard arm slings.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Spania
    • Catalonia
      • L'Hospitalet de Llobregat, Catalonia, Spania, 08907
        • Rekruttering
        • Bellvitge University Hospital
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Abdul-ilah Hachem, MD
        • Underetterforsker:
          • Hady Ezzeddine, MD
        • Underetterforsker:
          • Xavi Rius, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Adults aged ≥18 years undergoing arthroscopic soft-tissue stabilization for anterior shoulder instability (Bankart repair ± Hill-Sachs remplissage).
  • Ability and willingness to comply with the study protocol and scheduled follow-ups.
  • Provision of written informed consent.

Exclusion Criteria:

  • Significant glenoid bone loss requiring bony augmentation procedures (e.g., bone block procedures, Latarjet).
  • Concomitant rotator cuff repair or fracture fixation.
  • Contraindication to MRI (e.g., pacemaker, claustrophobia, incompatible implants).
  • Cognitive impairment, language barriers, or logistical inability to attend follow-up visits.
  • Previous ipsilateral shoulder surgery.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Dynamic Immobilizer
Continuous wear of the dynamic shoulder orthosis for 3 weeks post-surgery, followed by a standardized physiotherapy protocol.
Enhet: Dynamic Immobilizer
An adjustable strap system applied immediately post-surgery that permits movement of the shoulder joint while simultaneously limiting potentially harmful ranges of motion and translations. It is worn continuously for 3 weeks.
Andre navn:
  • medi® Shoulder action brace
Aktiv komparator: Standard Arm Sling
Continuous wear of a conventional fabric arm sling for 3 weeks post-surgery, followed by a standardized physiotherapy protocol.
Enhet: Conventional fabric arm sling
Static immobilization using a conventional fabric arm sling applied immediately post-surgery and worn continuously for 3 weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility composite (Recruitment, Retention, and Adherence)
Tidsramme: Up to 12 months post-surgery.
Evaluation of the feasibility of conducting a definitive randomized controlled trial by measuring the recruitment rate (percentage of eligible enrolled), retention/follow-up completion rates, and protocol adherence (self-reported and therapist-verified). Safety and device-related adverse events will also be recorded.
Up to 12 months post-surgery.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Western Ontario Shoulder Instability Index (WOSI)
Tidsramme: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Patient-reported functional outcome assessing quality of life related to shoulder instability.
Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Rowe Score
Tidsramme: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Clinical assessment of shoulder stability, mobility, and function.
Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Constant-Murley Score
Tidsramme: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Clinical assessment of general shoulder function, including pain, activities of daily living, range of motion, and strength.
Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Subjective Shoulder Value (SSV)
Tidsramme: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Patient-reported subjective function of the shoulder expressed as a percentage of a normal shoulder.
Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Range of Motion (ROM)
Tidsramme: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Active and passive flexion, abduction, and rotation measured via standardized goniometry by two blinded assessors.
Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Tidsramme: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Patient-reported outcome measure assessing physical function, symptoms, and related quality of life of the upper extremity.
Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
MRI Evaluation of Structural Healing
Tidsramme: Between 6 and 12 months post-surgery.
Assessment of capsulolabral integrity and bone defect remodeling, scored as intact, partial, or re-tear by two blinded physicians.
Between 6 and 12 months post-surgery.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hospital Universitari de Bellvitge

Etterforskere

  • Hovedetterforsker: Abdul-ilah Hachem, MD, Head of the Shoulder Unit, Department of Orthopaedics, Bellvitge Univeristy Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. juni 2026

Primær fullføring (Antatt)

15. desember 2027

Studiet fullført (Antatt)

15. juni 2028

Datoer for studieregistrering

Først innsendt

9. juni 2026

Først innsendt som oppfylte QC-kriteriene

9. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ICPS037/25 (Annen identifikator: Bellvitge Hospital Institutional Review Board (CEIm))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Data will be anonymized and stored in encrypted institutional servers in accordance with GDPR and HIPAA regulations. No data will be transferred to third parties outside the study team.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere