Multicenter, prospective, comparative study to assess the efficacy and safety of an anatomical total shoulder system.
Descrizione riassuntiva dello studio
In this study, a new anatomical shoulder prosthesis is implanted. The advantage of this prosthesis is that if your disease progresses and another surgery becomes necessary, it will be easier and require less effort. To assess the efficacy of the new prosthesis, clinical and functional evaluations, such as measuring shoulder mobility and muscle strength, will be conducted. Participants will be asked to complete questionnaires to assess satisfaction, symptoms, and function of the operated shoulder. The duration of follow-up is 24 months for each patient. To assess the safety of the new prosthesis, complications that may occur during the surgery and during the follow-up consultations of the patients will be analyzed to determine if there is a causal relationship with the prosthesis system. The X-rays of the shoulder performed during the follow-up consultations will be conducted according to normal clinical practice.
(BASEC)
Intervento studiato
All patients receive the same prosthesis. The data will be compared with those of a historical group that received a conventional anatomical shoulder prosthesis.
(BASEC)
Malattie studiate
Health conditions requiring prosthetic shoulder replacement, particularly in individuals with chronically inflamed shoulder joints or post-traumatic conditions.
(BASEC)
Patients, male and female, aged 18 years or older and with a shoulder condition requiring treatment with a total shoulder prosthesis. (BASEC)
Criteri di esclusione
You will be excluded from the study if you are not suitable for prosthetic treatment, if you currently have an infection, if mobility cannot be restored, or if you do not give consent to participate. (BASEC)
Luogo dello studio
Berna, San Gallo, Zurigo
(BASEC)
Sponsor
Medacta International SA
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Marco Viganò
0041 (0)91 696 6060
m.vigano@cluttermedacta.chMedacta International SA
(BASEC)
Informazioni scientifiche
Lindenhofgruppe AG (Bern),
+41 091 6966060
m.vigano@cluttermedacta.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
28.10.2021
(BASEC)
ID di studio ICTRP
NCT05062252 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Multicentric, prospective, comparative trial to assess the efficacy and safety of an anatomic total shoulder system. (BASEC)
Titolo accademico
Multicentric, Prospective, Comparative Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System. (ICTRP)
Titolo pubblico
Mirror Medacta Shoulder System Pivotal Trial (ICTRP)
Malattie studiate
Arthritis ShoulderPost-traumatic Arthrosis of Other Joints, Upper Arm (ICTRP)
Intervento studiato
Device: Mirror Medacta Shoulder SystemDevice: Medacta Shoulder System (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- Age = 18 yr
- Clinical indication for anatomic primary total shoulder replacement due to
osteoarthritis and/or posttraumatic arthritis
- Willingness and ability to comply with study protocol
Exclusion Criteria:
- Medical condition or balance impairment that could lead to falls
- Prior rotator cuff surgery
- Cuff tear arthropathy/insufficient rotator cuff
- Insufficient bone quality which may affect the stability of the implant
- Neuromuscular compromise of shoulder or other disabilities affecting the maximum
functional outcomes
- Weight bearing shoulder due to wheel chair, crutches, rollator at the time of
operation
- Active metastatic or neoplastic disease at the shoulder joint
- Chemotherapy treatment/radiotherapy within 6 mo before surgery
- >5 mg/day of corticosteroids, excluding inhalers, within 3 years before surgery
- Pregnancy or plan to become pregnant during study period
- Inability to understand study or a history of noncompliance with medical advice
- Alcohol or drug abuse
- Current enrollment in any clinical research study that might interfere with this
study
- Metal allergies or sensitivity.
- Previous or current infection at or near the site of implantation.
- Current distant or systemic infection
- Patient, whose infomed consent form should be taken in an emergency situation
- ONLY for women of childbearing age: a positive pregnancy test (urine / blood) (ICTRP)
non disponibile
Endpoint primari e secondari
Oxford Shoulder Score (ICTRP)
Device Success Rate;Oxford Shoulder Score;Constant score;Subjective Shoulder Value;Device parameters (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Matthias A Zumstein, Prof Dr. med;Marco Vigan?, PhD, m.vigano@medacta.ch, +41 091 6966060, Lindenhofgruppe AG (Bern), (ICTRP)
ID secondari
P06.003.01 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05062252 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile