Preoperative Psychological Risk Factors for the Retractable Capsulitis of the Shoulder After Shoulder Rotator Cuff Repair Surgery
2 other identifiers
observational
77
1 country
2
Brief Summary
The main objective of our study is to determine whether preoperative anxiety, depression and kinesiophobia are risk factors for retractile capsulitis after arthroscopic rotator cuff repair to best support these patients. patients postoperatively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 31, 2019
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedOctober 29, 2020
October 1, 2020
1.8 years
July 31, 2019
October 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
retractile capsulitis
rate of patients with retractile capsulitis defined as active anterior elevation less than 100 °, external rotation elbow to body less than 10 °, internal rotation less than L5
6 months postoperatively
Secondary Outcomes (4)
Hospital Anxiety and Depression Scale (HADS)
preoperatively and 6 months after surgery
Tampa Scale for Kinesiophobia (TSK)
preoperatively and 6 months after surgery
Numeric Pain Rating Scale
preoperatively and 6 months after surgery
Constant shoulder score
preoperatively and 6 months after surgery
Interventions
Rotator cuff repair performed arthroscopically
Eligibility Criteria
Patient who undergo rotator cuff repair under arthroscopy
You may qualify if:
- Patient over 18 years old
- Patient with rotator cuff rupture or subacromial conflict.
- Free and enlightened non-opposition
You may not qualify if:
- Pregnancy and breast feeding
- Associated repair of the scapular tendon
- Risk factors for capsulitis: diabetes, thyroid pathology, hypercholesterolemia, dupuytren's disease, homolateral breast surgery, history of myocardial infarction
- Patient not affiliated to a social security scheme
- Refusal of the patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, 75020, France
Ambroise Paré Hospital
Boulogne-Billancourt, Île-de-France Region, 92100, France
Related Publications (1)
Aim F, Chevallier R, Marion B, Klouche S, Bastard C, Bauer T. Psychological risk factors for the occurrence of frozen shoulder after rotator cuff repair. Orthop Traumatol Surg Res. 2022 Apr;108(2):103212. doi: 10.1016/j.otsr.2022.103212. Epub 2022 Jan 22.
PMID: 35077897DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Bauer, MD, PhD
Orthopaedic surgery department
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Research director
Study Record Dates
First Submitted
July 31, 2019
First Posted
August 5, 2019
Study Start
May 1, 2018
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
October 29, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share