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NCT Number: NCT04529798

Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless

The objectives of this study are the assessment of the clinical, radiographical and patient-reported outcomes of SMR Stemless Reverse Shoulder Arthroplasty (LimaCorporate S.p.A.) used as standard of care over a period of at least 2 years of follow-up and the evaluation of the incidence of any complication.

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Key information

Conditions

Rotator Cuff Tear Arthropathy Arthritis Chondrocalcinosis Crystal Arthropathies Joint Diseases Musculoskeletal Diseases Osteo Arthritis Shoulders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arthro Medics AG

Basel, Canton of Basel-City, 4054, Switzerland

Location status: Recruiting

Location contact

Claudio Rosso, PD Dr. med.

CONTACT

[email protected]

+41 61 301 26 26

About this study

The focus of this study is the evaluation on clinical, patient-reported and radiographical outcomes of SMR Stemless Reverse Shoulder Arthroplasty. There is a retrospective and prospective study population.

The follow up time-points are (as of standard of care and not different for this study):

  • Baseline
  • 6 weeks postop
  • 6 months postop
  • 12 months postop
  • 24 months postop

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • rotator-cuff arthropathy, osteoarthritis
  • approving written informed consent

Exclusion criteria

  • Female patients who are pregnant, nursing, or planning a pregnancy.
  • All adult patients with any of the SMR Stemless contraindication for use for the reverse configuration as reported in the current local Instruction for use.
  • not consenting in participating in this study

Treatment and study plan

Primary outcomes

  1. Subjective Shoulder Value score

    Time frame: 5 years

    Evaluation of the change of the Subjective Shoulder Value score from pre-operative to the last follow-up visit.

Secondary outcomes

  1. ASES Shoulder Score

    Time frame: 5 years

    Evaluation of the change of the ASES shoulder score from pre-operative to the last follow-up visit.

  2. Quick-Dash score

    Time frame: 5 years

    Evaluation of the change of the Quick-Dash score from pre-operative to the last follow-up visit.

  3. VAS pain

    Time frame: 5 years

    Evaluation of the change of the VAS pain score from pre-operative to the last follow-up visit.

  4. UCLA shoulder score

    Time frame: 5 years

    Evaluation of the change of the UCLA shoulder score from pre-operative to the last follow-up visit.

  5. Loosening, implant stability, radiolucent lines

    Time frame: 1 year

    Radiographic evaluation of the implant stability as rate and progression of symptomatic radiolucent lines and loosening.

Study contacts

Contact information is provided by the study sponsor or research team.

Claudio Rosso, PD Dr. med

CONTACT

[email protected]

+41 61 301 26 26

Sponsors and collaborators

Lead sponsor

Arthro Medics AG

Other

Registry information

Official study title

A Monocentric Clinical Study Evaluating Clinical and Patient-reported Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless

Acronym: SSPR

Important dates

Study start
2016
Primary completion
2024
Study completion
2025
First posted
Aug 28, 2020
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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