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Completed

NCT Number: NCT06316050

Retrovertion Assesment and Study in Elderly Patients With Reverse Total Shoulder Arthroplasty

Determine the optimal degree of retroversion (0-30º) to obtain the best rotational mobility, both internal and external, of the shoulder after implanting a reversed sghoulder arthroplasty (Comprehensive system), and analyze the functional and radiologic results based on humeral retroversion.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JM MORA

Terrassa, Barcelona, 08227, Spain

About this study

Methodology: Open randomized controlled clinical trial. It will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital from January 2019 to June 2021. The estimated sample will be 30 patients per group with diagnosis of massive rotator cuff rupture, rotator cuff arthropaty and primary osteoarthritis with cuff injury, with Walch's type B2 glena or in patients older than 80 years. A global study will be carried out preoperatively and postoperatively with radiographs, computerized tomography, magnetic resonance, and a biomechanical study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • men and women over 60 with the diagnosis rotator cuff massive break (Hamada 2 or more), arthrosis secondary to ruptures of the rotator cuff and primary osteoarthritis with lesion of the cuff, with full Walch B2 type or in patients older than 80 years. Inclusion criteria
  • Good functionality of the deltoid muscle.
  • Presence of minor round (Hornblower test - no muscle atrophy in nuclear magnetic resonance)
  • Accept informed consent

Exclusion criteria

  • - Review of hemiarthroplasty or anatomical proesis of the affected shoulder.
  • Fracture of shoulder in the upper extremity to intervene.
  • Central neurological diseases
  • Advanced cognitive impairment
  • Brachial plexus injuries
  • Local or systemic infection.
  • Oncological disease
  • Treatment with immunosuppressants.

Treatment and study plan

humeral retroversion

Procedure

REVERSED SHOULDER ARTHROPLASTY IN TWO DIFFERENT GROUPS. Group 0 humeral retroversion, Group 30º humeral retroversion

Primary outcomes

  1. INTERNAL ROTATION

    Time frame: 2 YEARS

    AT THE SIDE (HAND TO the BACK from CONSTANT TEST)

  2. INTERNAL ROTATION

    Time frame: 2 YEARS

    degrees

Secondary outcomes

  1. EXTERNAL ROTATION

    Time frame: 2 YEARS

    degrees

  2. FORWARD ELEVATION

    Time frame: 2 YEARS

    degrees

  3. Simple shoulder test

    Time frame: 2 years

    0-100

  4. Constant test

    Time frame: 2 years

    0-100

  5. ASES test

    Time frame: 2 years

    0-100

  6. Glenoid inclination angle

    Time frame: 2 years

    degrees

  7. glenoid retroversion angle

    Time frame: 2 years

    degrees

  8. abduction

    Time frame: 2 years

    degrees

  9. center of rotation

    Time frame: 2 years

    milimiters

  10. lateralizaiton offset

    Time frame: 2 years

    milimiters

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de Terrassa

Other

Registry information

Official study title

Retrovertion Assesment and Study of the Subscapularis Function in Elderly Patients With Reverse Total Shoulder Arthroplasty

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Mar 18, 2024
Registry last updated
Mar 18, 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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