Clinical Research Directory

Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis

The present study try to evaluate the effectivenness of an early intervention program based on multimodal physiotherapy and focused on therapeutic exercise to improve the results of patients with a reverse shoulder phrostesis. This trial will be a randomized controlled trial with parallel groups, and outcomes variables will include psychometric properties through the use of specific questionnaries, and laboratory variables such as strength with a dynamometer, range of movement with a goniometer, muscle mass with an ultrasound, and kinematic parameters with inertial sensors. This study aims to develop an original intervention program in order to try to establish new protocols in the management of these patients.

OsseoFit Stemless Shoulder System (Anatomic)

The purpose of this clinical research protocol is to evaluate the safety, efficacy, and long-term outcomes of the OsseoFit Stemless Shoulder System (Anatomic) in patients with a primary diagnosis of osteoarthritis. The study aims to assess the intraoperative characteristics, postoperative complications, functional outcomes, and radiographic findings associated with the use of the stemless implant system. Ultimately, this research aims to improve patient outcomes, enhance surgical techniques, and inform clinical decision-making in the treatment of shoulder pathology.

MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

The objective of this retrospective/prospective consecutives series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7, and 10- year follow-up\* to meet EU Medical Device and other Regulatory Requirements for Post-Market Surveillance. Because Comprehensive Versa-Dial Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well to collect long-term data. \*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point.

Zimmer Biomet Shoulder Arthroplasty PMCF Study

This is a multicenter, prospective, non-controlled post market surveillance study. The objectives of this study are to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems in primary anatomic shoulder arthroplasty and its instrumentation. Safety of the systems will be assessed by monitoring the frequency and incidence of adverse events. The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, qualify of life, and radiographic parameters of all enrolled study subjects.

MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head

The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,3,5,7 and 10 years\*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will be utilized in order to collect long-term data.

Zimmer Biomet Shoulder Arthroplasty PMCF

The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty. These objectives will be assessed using standard scoring systems, radiographic evidence, and adverse event records. Safety of the system will be assessed by monitoring the frequency an incidence of adverse events.

Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years

The goal of this clinical trial is to study whether surgery results in better functional outcomes than non-surgical treatment among patients aged 50-65 with a displaced proximal humerus fracture. The main questions it aims to answer are: • Does osteosynthesis result in better patient-reported functional outcomes compared to non-surgical treatment at 12 months follow-up? Aim is also to characterize the patient group aged 50-65 regarding fracture morphology, osteoporosis, and clinical frailty scale. The study compare operation with either plate or nail fixation to non-surgical treatment. Participants will: * Receive either surgical treatment or non-surgical treatment. * At 6 months, 1 year, and 2 years, the patient will answer two short questionnaires (Oxford Shoulder Score and Eq-5D-3L). The primary outcome will be Oxford Shoulder Score at 12 months. The secondary outcome will be OSS at 6 and 24 months and EQ-5D-3L score measured at the same time-points. Adverse events and conversion to surgery will be registered. OSS and EQ-5D-3L will be completed just before the 6 months visit.

MDR - Comprehensive Primary Revision Stems PMCF

The objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary Revision Stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.

Management of Proximal Humerus Fractures in Adults: a Clinical Trial

Prospective patient registry examining the outcome of three different treatment methods for proximal humerus fractures in elderlies: conservative treatment, open and minimal invasive surgical treatment.