Clinical trial NCT05232773: Rotator Cuff Surgery in Athletes: From Rehabilitation to Return to Sport
Official title: Rotator Cuff Surgery in Athletes: From Rehabilitation to Return to Sport
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rotator Cuff Tears
Athletes
Return to Sport
Keywords: Shoulder
Return to Sport
Rehabilitation
Athletes
Rotator Cuff
Rotator Cuff Injuries
Rotator Cuff Tears
Pilot Study
Assessment
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Competitive and non-competitive athletes undergoing rotator cuff repair surgery at the Unit of Orthopedics and Traumatology of the Campus Bio-Medico University Hospital will be considered eligible.

Brief summary: The main goal of this project is to study and define a rehabilitative flow-chart for athletes' rehabilitation and return to sport made by a set of objective shoulder evaluation indicators that are easy to use in clinical context. Enrolled patients will undergo supervised rehabilitation treatment for rotator cuff repair according to a standardized protocol (5 days/week) and will undergo four evaluation at different times. Healthy subjects will undergo evaluations with the same timing as patients.

Detailed description: Clinical, kinematic and shoulder muscle strength assessments to collect data useful to define objective criteria for progression between rehabilitation phases will be performed according to the following times:

* T1 - 4-6 weeks after surgery: PROM assessment, pain assessment at rest and during PROM, Constant-Murley score (CMS).
* T2 - 6-12 weeks after surgery: AROM assessment (flexion in scapular plane, abduction, external and internal rotation), pain assessment at rest and during PROM and AROM tasks, scapular humeral rhythm, CMS.
* T3 - 12-16 weeks after surgery: AROM assessment (flexion in scapular plane, abduction, external and internal rotation), pain assessment at rest and during PROM and AROM tasks, scapular humeral rhythm, isometric strength assessment, CMS; joint proprioception assessment (joint position sense).
* T4 - 16-24 weeks after surgery: AROM assessment (flexion in scapular plane, abduction, external and internal rotation), scapular humeral rhythm, isometric strength assessment, CMS, joint proprioception assessment (joint position sense), movement speed and smoothness.

Enrolled patients will undergo supervised rehabilitation treatment for rotator cuff repair according to a standardized protocol (5 days/week) and will undergo the evaluations. Healthy subjects will undergo evaluations with the same timing as patients.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years
* Mini Mental Status Examination (MMSE)\> 24
* Acceptance and signature of informed consent

Exclusion Criteria:

* Presence of other pathologies that can compromise the standard post-operative course (shoulder instability; reoperation for failed rotator cuff repair; neurological and cognitive problems)

Primary outcomes:
measure: To study and define a rehabilitative flow-chart for athletes' rehabilitation and return to sport
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Campus Bio-Medico
Study officials:
affiliation: Campus Bio-Medico University
name: Rocco Papalia, Professor
role: PRINCIPAL_INVESTIGATOR
References: