Multicenter, prospective, comparative study to assess the efficacy and safety of an anatomical total shoulder system.
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Bern, St Gallen, Zürich
(BASEC)
Sponsor
Medacta International SA
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Marco Viganò
0041 (0)91 696 6060
m.vigano@cluttermedacta.chMedacta International SA
(BASEC)
Wissenschaftliche Auskünfte
Lindenhofgruppe AG (Bern),
+41 091 6966060
m.vigano@cluttermedacta.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
28.10.2021
(BASEC)
ICTRP Studien-ID
NCT05062252 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Multicentric, prospective, comparative trial to assess the efficacy and safety of an anatomic total shoulder system. (BASEC)
Wissenschaftlicher Titel
Multicentric, Prospective, Comparative Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System. (ICTRP)
Öffentlicher Titel
Mirror Medacta Shoulder System Pivotal Trial (ICTRP)
Untersuchte Krankheit(en)
Arthritis ShoulderPost-traumatic Arthrosis of Other Joints, Upper Arm (ICTRP)
Untersuchte Intervention
Device: Mirror Medacta Shoulder SystemDevice: Medacta Shoulder System (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Oxford Shoulder Score (ICTRP)
Device Success Rate;Oxford Shoulder Score;Constant score;Subjective Shoulder Value;Device parameters (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Matthias A Zumstein, Prof Dr. med;Marco Vigan?, PhD, m.vigano@medacta.ch, +41 091 6966060, Lindenhofgruppe AG (Bern), (ICTRP)
Sekundäre IDs
P06.003.01 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05062252 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar