- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07925788
Arthroscopy-Assisted Lower Trapezius Transfer Using Long Head of Biceps Tendon Autograft as an Interposition Graft for Massive Irreparable Rotator Cuff Tears (LHBT)
The aim of the study is To evaluate the clinical, functional, and radiological outcomes of arthroscopically assisted lower trapezius tendon transfer using LHBT autograft as an interposition graft for massive irreparable rotator cuff tears., in terms of pain relief, shoulder range of motion, external rotation strength, patient-reported functional scores, and structural integrity of the transfer.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Massive rotator cuff tears represent a major cause of shoulder pain and disability among middle-aged and older patients. In younger, active patients with symptomatic massive irreparable tears, joint-preserving reconstructive procedures are generally favored over arthroplasty in order to maintain native anatomy and delay the need for prosthetic replacement. Tendon transfer of latissmus dorsi is preferered with autograft like Achillis tendon or semitendonosus tendon in this study we will use Long head of biceps tendon as interposition graft and evaluate the result clinicaly radiologicaly and functionaly postoperative
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mahmoud M S Mahran, MD
- Telefonnummer: 00201018882565
- E-post: mahmoudmahran408@gmail.com
Studer Kontakt Backup
- Navn: Esraa S Kotb, Master
- Telefonnummer: 01009595394
- E-post: Esraasayed845@gmail.com
Studiesteder
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Asyut Governorate
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Asyut, Asyut Governorate, Egypt, 71524
- Al-Azhar University Hospital, Assiut
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria :
- symptomatic massive posterosuperior rotator cuff tear (involving ≥2 tendons and/or ≥5 cm in the anteroposterior dimension) confirmed by MRI
- Tear confirmed intraoperatively as irreparable despite maximal mobilization (medialized footprint repair not feasible)
- Intact or repairable subscapularis tendon
- Intact deltoid muscle function
- Failure of at least 3-6 months of conservative treatment (physiotherapy, analgesics, activity modification) or prior failed rotator cuff repair
- Preoperative active or passive forward elevation ≥ 0°-30° (i.e., not a pseudoparalytic shoulder with fixed loss of elevation, per surgeon's assessment) - to be defined per the surgical team's operative criteria
- Available and functioning lower trapezius muscle and long head of biceps tendon on preoperative examination/imaging
- Patient willing and able to comply with the postoperative rehabilitation protocol and scheduled follow-up visits
Exclusion criteria :
- Advanced glenohumeral osteoarthritis (Hamada grade ≥ 3)
- Irreparable subscapularis tear or anterosuperior tear pattern
- Deltoid dysfunction, paralysis, or previous deltoid detachment
- Lower trapezius dysfunction, atrophy, or prior denervation (e.g., spinal accessory nerve injury)
- Long head of biceps tendon absent, previously ruptured, or already tenotomized/tenodesed
- Axillary nerve palsy or brachial plexus injury
- Active glenohumeral or periprosthetic infection
- Uncontrolled systemic disease precluding surgery (e.g., uncontrolled diabetes mellitus, severe cardiopulmonary disease)
- Inflammatory arthropathy of the shoulder
- Previous ipsilateral shoulder arthroplasty
- Patients unable or unwilling to give informed consent or to comply with follow-up
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Long head of biceps tendon autograft
We asses the outcomes of Arthroscopy-Assisted Lower Trapezius Transfer Using Long Head of Biceps Tendon Autograft as an Interposition Graft for Massive Irreparable Rotator Cuff Tears |
Arthroscopy-Assisted Lower Trapezius Transfer Using Long Head of Biceps Tendon Autograft as an Interposition Graft for Massive Irreparable Rotator Cuff Tears |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
change in Constant-Murley Shoulder Score
Tidsramme: 6 weeks, 3, 6,9,months and 1 year
|
The Constant-Murley Shoulder Score (CMS) is a 100-point combined subjective and objective scoring system designed to assess overall shoulder function: Maximum Score: 100 points (indicates best possible shoulder function) Minimum Score: 0 points (indicates severe limitation/impairment) |
6 weeks, 3, 6,9,months and 1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual analog score VAS
Tidsramme: 6 weeks, 3, 6,9,months and 1 year
|
psychometric response scale used to measure subjective pain intensity, including shoulder pain: Standard Format: A 10 cm (100 mm) horizontal line anchored by two extreme descriptors at each end: 0 cm (0 mm): "No pain" 10 cm (100 mm): "Worst imaginable pain" (or "Worst pain ever felt") |
6 weeks, 3, 6,9,months and 1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
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
Andre studie-ID-numre
- Azhar university Assiut
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Data will be available with a corresponding offer on reasonable request
Legemiddel- og utstyrsinformasjon, studiedokumenter
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