• Assessment of clinical, radiographic and subjective outcomes after anatomic or reverse shoulder arthroplasty with SMR stemless prosthesis;• Survival analysis;• Incidence of adverse events and identification of possible risk factors for failure.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint consist of the proportion of patients reaching a clinical
progression from
baseline to 24-month follow-up measured as:
• Constant score change of greater than 10;
• Adjusted Constant score greater than or equal to 54.
Secondary outcome
The secondary endpoints are:
• improvement from patient perspective from baseline to 24-month follow-up
measured as change of the ASES score, Oxford shoulder score and patient
satisfaction;
• stability of the humeral component, intended as rate of symptomatic
radiolucent lines, loosening and subsidence >=2 mm, from immediate postoperative
(baseline) to 24-month;
• Failure rate, intended as removal of the humeral component, from immediate
postoperative (baseline) to 24-month;
• Incidence of device-related AE/SAE (ADE/SADE) from immediate postoperative
(baseline) to 24-month.
Background summary
The SMR Stemless System was developed maintaining the modularity concept of the
SMR Shoulder System in order to provide solutions for wide variations of
indications encountered in shoulder arthroplasty surgery. It allows to perform
anatomic or reverse shoulder arthroplasty using the same SMR Stemless Core
which does not need to be replaced in case of revision surgery if it is stable
and well osseointegrated.
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.
Study objective
• Assessment of clinical, radiographic and subjective outcomes after anatomic
or reverse shoulder arthroplasty with SMR stemless prosthesis;
• Survival analysis;
• Incidence of adverse events and identification of possible risk factors for
failure.
Study design
Post-market, prospective, consecutive series, non randomized, open label,
internal control
Study burden and risks
Shoulder replacement is the routine treatment following diagnosis of
degenerative shoulder disease.
The possible risks and/or discomforts associated with this shoulder replacement
operation are identical to those for all standard total shoulder replacement
operations and are independent from the decision to participate in this study.
The patients will visit the clinic at regular follow-up moments up to one year,
and will receive a travel reimbursement for the additional visits. All visits
take ±15 min extra than regularly because at these moments the patient visits
also the research nurse for data collection. The questionnaires and physical
examinations of the shoulder do not bring any extra burden. The additional
radiographic assessments increase the total amount of radiation only slightly.
However, the total amount of radiation falls within the limits for medical
research.
Limacorporate S.p.A. Via Nazionale 52
Villanova di San Daniele del Friuli 33038
IT
Limacorporate S.p.A. Via Nazionale 52
Villanova di San Daniele del Friuli 33038
IT
Listed location countries
Age
Inclusion criteria
- Patient is requiring primary unilateral or bilateral anatomic or reverse
arthroplasty based on physical examination and medical history;
- Good bone quality evaluated by the Investigator on the basis of a risk
factors analysis (included MORES/SCORE questionnaires) and the intraoperative
evaluation;
- A diagnosis in the target shoulder of one or more of the following:
• Primary osteoarthritis;
• Secondary osteoarthritis;
• Post-traumatic arthritis;
• Rheumatoid arthritis;
• Avascular necrosis of the humeral head (radiologically less than 20%);
• Cuff tear arthropathy.
- Patient submitted to previous conservative non-surgical treatments;
- Patient is willing and able to complete scheduled follow-up evaluations as
described in the Informed Consent;
- Patient has participated in the Informed Consent process and has signed the
Informed Consent form previously approved by the Ethics Committee.
Exclusion criteria
- Patient requiring revision shoulder arthroplasty;
- Osteoporosis with a history of non-traumatic fractures;
- Steroid injections within the previous 3 months;
- Contralateral shoulder replacement within the previous 3 months;
- Extensive avascular necrosis (radiologically more than 20%);
- Meta-epiphyseal bony defect (including large cysts);
- Post-traumatic tuberosity non-union;
- Ongoing septicaemia;
- Significant proven or suspicious infection of the target shoulder or any
serious infectious disease before the study according to the Investigator;
- Significant neurological or musculoskeletal disorders that may compromise
functional recovery;
- Not recovered axillary nerve palsy;
- Non functioning deltoid muscle;
- Known or suspicious hypersensitivity to the metal or other components and
materials of the implant;
- Recurrent medical history of immune-mediated reactions or other systemic
immune disorders;
- Current treatment or treatment for any malignancy within the previous 2 years
before the preoperative visit;
- Previous organ transplant;
- Women of childbearing potential who are pregnant, nursing, or planning
to become pregnant.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54378.094.15 |