SMR Stemless Shoulder Arthroplasty Clinical Study
|ClinicalTrials.gov Identifier: NCT02679352|
Recruitment Status : Active, not recruiting
First Posted : February 10, 2016
Last Update Posted : February 28, 2020
Shoulder arthroplasty is a reliable procedure for the treatment of severe shoulder joint diseases to relieve pain and restore shoulder function.
Shoulder implants commonly used are characterised by a humeral stem and complications related to the stem are not infrequent. These include: bone stock loss, intraoperative and postoperative break around the implant, malpositioning of the humeral component and difficult eradication of infections inside the bone around the implant.
With the aim of reducing stem-related complications, a novel prosthesis characterised by a stem-less design has been developed.
The objective of this study is therefore to explore how well people recover after shoulder replacement with this novel stem-less shoulder prosthesis. This will be assessed over 5 years in three different countries in Europe using patient completed questionnaires and clinical and radiographic assessments.
|Condition or disease||Intervention/treatment||Phase|
|Primary Osteoarthritis Secondary Osteoarthritis Post-traumatic; Arthrosis Rheumatoid Arthritis Avascular Necrosis of the Head of Humerus Rotator Cuff Tear Arthropathy||Device: SMR Stemless||Not Applicable|
The hypothesis at the base of the study is that the SMR stemless system might contribute to ensure good clinical outcomes and an effective stability and might avoid the potential complications associated with a traditional stemmed implant.
The aim of this study is to assess clinical, radiographic and subjective outcomes after anatomic or reverse shoulder arthroplasty with a SMR stemless prosthesis, define the survivorship of the implant and identify possible risk factors that may lead to failure.
This is a post-marketing clinical study, because the study device is registered, CE marked and used according to the intended use.
It is an international, multi-centre, prospective case series. The assignment of any patient involved in the study is determined by the aetiology preoperatively evaluated by the Investigator and falls within current practice. The decision to use a specific prosthesis design is decided by the Investigators independently and clearly separated from the decision to include the patient in the study.
The evaluation has an internal control because the assessment of post-surgery data is compared to baseline measurements (pre-operative clinical analysis and radiographic analysis at discharge). It is open label.
The investigation will be carried out in 3 sites in Europe for a maximum total number of 78 treated patients. Accrual will be competitive until the required recruitment target is met. Equal numbers will be recruited at each of three centres (26 patients per site), but a deviation of 8 participants will be accepted (minimum of 18 and maximum of 34 participants recruited per site).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre, Prospective Clinical Study Analysing Outcomes of Shoulder Arthroplasty With SMR STEMLESS|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2024|
Experimental: SMR stemless
Patients requiring a primary anatomic or reverse shoulder arthroplasty, due to symptomatic painful degenerative joint diseases with good bone stock
Device: SMR Stemless
Total anatomic or reverse shoulder arthroplasty
- Efficacy as assessed by proportion of patients reaching a clinical progression measured as Constant score change [ Time Frame: 24 months ]Constant score change of greater than 10 points
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679352
|St. Anna Hospital|
|Herne, Germany, 44649|
|Hoofddorp, Netherlands, 2134 TM|
|Zorgsaam Zorggroep Ziekhenhuis Terneuzen|
|Terneuzen, Netherlands, 4535|
|North Bristol NHS|
|Bristol, United Kingdom, BS10 5NB|