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Completed

NCT Number: NCT03986749

Bursa Augmentation in Arthroscopic Rotator Cuff Repair

The aim of this first study is to investigate in a case series through sequential sonographic imaging, using Doppler ultrasonography, the postoperative morphology, especially vascularity and findings of neovascularity, after bursa augmentation in arthroscopic rotator cuff repair.

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Key information

Conditions

Rotator Cuff Tear or Rupture, Not Specified as Traumatic Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schulthess Klinik

Zurich, Canton of Zurich, 8008, Switzerland

About this study

The outcome of rotator cuff (RC) reconstruction with and without bursa augmentation, considering also the inflammatory status of the bursa, will be systematically investigated for the first time. The influencing role of the inflammatory status of the bursa, of the RC tendon and the synovial membrane at the time of the operation on the tendinous healing rate, the patient-relevant outcome factors and the revision rate will be assessed. In a further approach, basic knowledge about the role of bursa inflammation and its influence in the development and regeneration of tendon pathologies shall be gained. The findings of the whole project could lead to improve tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient aged 18 years and older
  • Patient with C-shaped posterosuperior rotator cuff tear (SSP / ± ISP, ± SCP Tear Lafosse ≤ 1 (SCP no repair, only debridement))
  • Retraction ≤ 2 according to Patte
  • Fatty infiltration ≤ 2 according to Goutallier
  • Eligible for arthroscopic double row rotator cuff repair in Suture Bridge technique.
  • Written informed consent

Exclusion criteria

  • Legal incompetence
  • Last subacromial cortisone infiltration ≤ 6 months
  • Systemic rheumatologic-inflammatory disease
  • Diabetes Mellitus
  • Smoker

Treatment and study plan

Doppler ultrasonography after bursa augmentation

Procedure

Dynamic ultrasound examination with Grading of blood vessels using the modified Ohberg Score in the longitudinal scan in dynamic ultrasound of the rotator cuff tendon - primary to surgery and 3 weeks later.

Primary outcomes

  1. Dynamic ultrasound examination with grading of blood vessels

    Time frame: 3 months

    using the modified Ohberg Score

Secondary outcomes

  1. Tendon integrity

    Time frame: 6 months

    intact / partially ruptured / ruptured

  2. Tendon condition

    Time frame: 6 months

    Thickness of the repaired tendons (mm)

  3. Range of motion

    Time frame: 6 months

    Elevation (flexion), abduction, external rotation by 0° abduction, external-internal rotation by 90° abduction

  4. Shoulder muscle strength

    Time frame: 6 months

    Shoulder strength in 90° Abduction (kg) measured using a spring balance

  5. Oxford Shoulder Score (OSS)

    Time frame: 6 months

    Patient-reported Oxford Shoulder Score from 0 (worse) to 48 (best)

  6. Subjective shoulder value (SSV)

    Time frame: 6 months

    Patient-reported Subjective shoulder value from 0 (worse) to 100% (best)

  7. Constant Murley score (CMS)

    Time frame: 6 months

    Constant Murley functional score from 0 (worse) to 100 (best)

  8. Level of satisfaction

    Time frame: 6 months

    Level of satisfaction using Number Rating Scale from 0 (not satisfied) to 10 (highly satisfied)

  9. EQ-5D utilities

    Time frame: 6 months

    Patient-reported Quality of life (EuroQol EQ-5D-5L) as Utility index from 0 (worse) to 1 (best health)

  10. Adverse events

    Time frame: 6 months

    Number of patients with adverse events

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Registry information

Official study title

Biological Augmentation With Subacromial Bursa in Arthroscopic Rotator Cuff Repair - Postoperative Findings Using Doppler Ultrasonography

Acronym: ARCR-Bursa

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 14, 2019
Registry last updated
Jun 3, 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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