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OpenTrials
Completed

NCT Number: NCT05234385

Functional Outcome Following Surgical Treatment of Patients With Sternoclavicular Joint Infection

The Sternoclavicular joints (SCJ) represents an important factor in stability of shoulder joint. Its influence and its function is important for the functionality of the shoulder. SCJ infection is a rare condition and remains often mistreated and potentially life threatening.

This study is to assess the cases treated at the University Hospital Basel with a surgical approach of extended resection of the SCJ. One prospective follow-up visit inclusive one physical examination per patient will be performed to evaluate the long-term functional results of arm, shoulder, hand function with the QuickDASH questionnaire.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Thoracic Surgery, University Hospital of Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient assigned and treated at the Department of Thoracic Surgery, University Hospital Basel (USB)
  • At hospital admission diagnosed with clinical characteristics of sternoclavicular joint infection
  • Surgical treatment of extended SCJ resection received
  • Signed written informed consent according to ICH-GCP regulations prior to initiation of any protocol-specific activities/procedure
  • Patients who died will be included if a signed USB general research consent is available

Exclusion criteria

  • Isolated sternal or clavicular infection
  • Patients received other surgery than extended SCJ resection at USB thoracic surgery
  • Inability to follow procedures or insufficient knowledge of language (German/French) or inability to give consent
  • Patients who have clearly stated that they would not agree in providing their clinical data for scientific purposes

Treatment and study plan

Primary outcomes

  1. QuickDASH score

    Time frame: one time assessment at the prospective follow-up visit (timeframe of maximal 1 hour)

    QuickDASH score of the mobility of the arm, shoulder, hand and its function by using the QuickDASH questionnaire. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (4 items, scored 1-5). A higher score indicates greater disability.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: SCJ Infection

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2022
Registry last updated
Jun 5, 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.