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SMR Stemless Shoulder Arthroplasty Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679352
Recruitment Status : Active, not recruiting
First Posted : February 10, 2016
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Limacorporate S.p.a

Brief Summary:

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

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patients meeting all the following inclusion criteria will be considered for participation in the study:

  1. Both genders;
  2. Age ≥ 18 years old;
  3. Full skeletal maturity;
  4. Life expectancy over 5 years;
  5. Patient is requiring primary unilateral or bilateral anatomic or reverse arthroplasty based on physical examination and medical history;
  6. Good bone quality evaluated by the Investigator on the basis of a risk factors analysis (included MORES/SCORE questionnaires) and the intraoperative evaluation;
  7. 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.
  8. Patient submitted to previous conservative non-surgical treatments;
  9. Patient is willing and able to complete scheduled follow-up evaluations as described in the Patient Information Sheet;
  10. Patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee.

Patients will be excluded if they meet any of the following criteria:

  1. Patient requiring revision shoulder arthroplasty;
  2. Osteoporosis with a history of non-traumatic fractures;
  3. Steroid injections within the previous 3 months;
  4. Contralateral shoulder replacement within the previous 3 months;
  5. Extensive avascular necrosis (radiologically more than 20%);
  6. Meta-epiphyseal bony defect (including large cysts);
  7. Post-traumatic tuberosity non-union;
  8. Ongoing septicaemia;
  9. Significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the Investigator;
  10. Significant neurological or musculoskeletal disorders that may compromise functional recovery;
  11. Not recovered axillary nerve palsy;
  12. Non functioning deltoid muscle;
  13. Known or suspicious hypersensitivity to the metal or other components and materials of the implant;
  14. Recurrent medical history of immune-mediated reactions or other systemic immune disorders;
  15. Current treatment or treatment for any malignancy within the previous 2 years before the preoperative visit;
  16. Previous organ transplant;
  17. Any intercurrent chronic disease or condition and any significant finding that may interfere with the completion of the 60-month follow-up, such as liver disease, severe coronary disease, or other clinically significant condition that the Investigator feels may affect the study evaluation;
  18. Unwillingness or inability (alcoholism, infirmity) to comply with rehabilitation and to return for follow-up visits and any psychiatric illness that would prevent comprehension of the details and nature of the study;
  19. Participation in any experimental drug/device study within the 6 months prior to the preoperative visit;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679352


Locations
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Germany
St. Anna Hospital
Herne, Germany, 44649
Netherlands
Spaarne Hospital
Hoofddorp, Netherlands, 2134 TM
Zorgsaam Zorggroep Ziekhenhuis Terneuzen
Terneuzen, Netherlands, 4535
United Kingdom
North Bristol NHS
Bristol, United Kingdom, BS10 5NB
Sponsors and Collaborators
Limacorporate S.p.a
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Responsible Party: Limacorporate S.p.a
ClinicalTrials.gov Identifier: NCT02679352    
Other Study ID Numbers: S-08
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Osteoarthritis
Joint Diseases
Rotator Cuff Tear Arthropathy
Necrosis
Rotator Cuff Injuries
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Chondrocalcinosis
Crystal Arthropathies