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NCT Number: NCT04460118

Clinical and Radiographic Outcomes in Arthroscopic "Inlay"Bristow Surgery With Screw Fixation vs Suture-button Fixation

Retrospective comparative case-cohort study to investigate the efficacy of the modified arthroscopic Bristow-Latarjet surgery and to compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.

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Key information

Conditions

Shoulder; Dislocation, Chronic Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Joint Diseases Joint Dislocations Lung Diseases Lung Diseases, Obstructive Musculoskeletal Diseases Organizing Pneumonia Respiratory Tract Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

PekingUTH

Beijing, Beijing Municipality, China

About this study

Background：Some studies have advocated the use of suture-button fixation during Bristow-latarjet surgery to reduce complications associated with screw fixation. However, these studies are not comparative studies, and their data are relatively incomplete.

Purpose: To compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.

Study Design: Retrospective comparative case-cohort study Methods: Patients who underwent the modified arthroscopic Bristow-Latarjet surgery between June 2015 and February 2018 were selected. Shoulders were separated into two groups based on surgical fixation method. Radiological results on 3D CT scan and clinical results were assessed preoperatively, immediately after operation, and postoperatively at 3 months, 6 months, 1 year and during the final follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • a glenoid defect ≥10%
  • contact sport athletes with a glenoid defect < 10%
  • failure after Bankart repair.

Exclusion criteria

  • epilepsy
  • multidirectional shoulder instability
  • concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps
  • Follow-up was less than 2 years or incomplete follow-up data.

Treatment and study plan

Bristow surgery fixed by the screw

Procedure

Bristow surgery fixed by the screw

Bristow surgery fixed by the suture button

Procedure

Bristow surgery fixed by the suture button

Primary outcomes

  1. VAS for pain score

    Time frame: 2 years after surgery

    The visual analog scale (VAS) for pain score is the most commonly used to describe pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.

  2. ASES score

    Time frame: 2 years after surgery

    The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.

Secondary outcomes

  1. Active shoulder ranges of motion

    Time frame: 2 years after surgery

    internal rotation at the side, and external and internal rotation at 90° of abduction,

  2. Bone block position

    Time frame: immediately after surgery.

    Bone block position was evaluated using postoperative CT scans.The ideal position of the bone block was defined as flush to the anterior glenoid rim in the axial view and 4 o'clock in the En face view. The bone block was considered too lateral if it went beyond the glenoid rim by more than 5 mm and it was judged to be too medial if it was medial to the rim by more than 5 mm.

  3. Bone union

    Time frame: 3 months after surgery, 6 months after surgery, 1 year after surgery and 2 years after surgery

    Graft union with the glenoid was assessed using postoperative CT scans. ''Bony union'' of the transplant was defined as no radiolucent zone; ''fibrous union,'' when the transplant had a radiolucent zone of less than 5 mm; and ''migration,'' when the zone was 5 mm or more.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 7, 2020
Registry last updated
Jul 7, 2020

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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