Clinical trial NCT04388306: Shoulder Functional Performance After Shoulder Surgery
Official title: Functional Performance of Shoulder After Arthroscopic Rotator Cuff Repair and Investigation of Performance Related Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tears
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group consists of participants with undergone arthroscopic RC repair at Bolu Abant İzzet Baysal University, Department of Orthopedics and Traumatology.

Brief summary: Rotator Cuff (RC) injuries are a progressive clinical condition that starts with an acute tendonitis, continues with partial thickness rupture and results in a full thickness rupture in the advanced period.

Arthroscopic RC repair is effective in the acute RC ruptures treatment caused by traumatic events. In the acute period after arthroscopic RC repair, shoulder joint range of motion (ROM), muscle strength and shoulder functionality are decreased and daily activities are adversely affected. In the long-term, many studies have reported that these symptoms gradually decreaced.

Many studies investigating postoperative treatment of RC rupture have mostly focused on parameters such as postoperative pain, functionality, muscle strength, ROM and quality of life.Evaluation of these clinical parameters is necessary for patient follow-up in the early period. However, it is unclear whether the biomechanical etiologic factors continue that lead to RC rupture in the advanced period after surgery.

Therefore, the objective of this study was functional performance of shoulder after arthroscopic Rotator Cuff repair and ınvestigation of performance related factors.

Detailed description: Design: observational Cross-sectional study.

Eligibility criteria: Inclusion Criteria:

* With the same RC surgical procedure and technique,
* With acromioplasty and/or tenodesis with RC repair,
* Undergoing arthroscopic RC repair from the upper extremity of the dominant side,
* Having completed the 12th week after surgery,
* Performing 90° and above active shoulder elevation movement

Exclusion Criteria:

* Having undergone revision surgery or previous shoulder surgery, a history of fracture of the upper extremity
* Having undergone surgery causing limitation of motion in the spine,
* Having a neurological and/or vestibular and/or rheumatologic disease,
* Participants with diabetes mellitus, hypertension, cardiovascular and chronic respiratory disease that may cause problems during the test

Primary outcomes:
measure: Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)
timeFrame: Three months
Secondary outcomes:
measure: Modified Constant Murley Score
timeFrame: Three months
measure: Scapular Muscle Endurance Test
timeFrame: Three months
measure: Total Upper Extremity Muscle Strength
timeFrame: Three months
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal University
state: Central
Study officials:
affiliation: Abant Izzet Baysal University
name: Beyza YAZGAN DAĞLI
role: PRINCIPAL_INVESTIGATOR
References: