Accelerated Rehabilitation After Arthroscopic Bankart Repair Surgery

Bankart Lesion Clinical Trial

Official title:

Accelerated Rehabilitation After Arthroscopic Bankart Repair Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347019
• Other study ID #: GO 16/471-14
• Status: Completed
• Phase: N/A
• Start date: December 15, 2016
• Est. completion date: March 15, 2019

Study information

• Verified date: April 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to prospectively evaluate the efficacy of an accelerated rehabilitation regime for patients undergoing early arthroscopic stabilization for first-time anterior dislocation in terms of clinical outcome, return to play data and recurrence rates.

Description:

Traditional rehabilitation regimes post arthroscopic stabilization commonly stipulate a period of immobilization of between 2 weeks and 6 weeks.This is apparently embedded in practice and is reportedly based on tissue healing times. However early mobilisation would allow good clinical results in terms of clinical outcome, return to play data and recurrence rates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Patient were included based on their history of a clear mechanism of injury resulting in traumatic anterior dislocation, with clear evidence of labral injury confirmed on magnetic resonance imaging.

Exclusion Criteria:

• patients with inflammatory, autoimmune, endocrine or kidney diseases

• Recurrence

• Bony Bankart Lesion

Related Conditions & MeSH terms

• Bankart Lesion
• Bankart Lesions

Intervention

Other:
• Accelerated rehabilitation
advances in arthroscopic surgery have resulted in biomechanically stronger repairs that might allow for accelerated rehabilitation protocols and hence faster return to daily living activities and scapular control
• Delayed rehabilitation
Patients were not allowed to start rehabilitation programme first three weeks after surgery.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 Dimensional Kinematic Analysis	Scapular kinematic measurements were conducted by using three-dimensional electromagnetic system (Motion Monitor® Skeleton Analysis System, Innovative Sports Training Inc, Chicago, USA). The three-dimensional electromagnetic system consists of motion monitor software, transmitters and sensors integrated into this software (Flock of Birds System).	at sixth months after surgery
Secondary	Pain Assessment	Pain was assessed by using numeric Visual Analogue Scale at rest, at night and during daily living activities. In numeric Visual Analogue Scale 0 represents "no pain", 10 represents "unbearable pain"	at sixth months after surgery
Secondary	First Functional Assessment	1. The Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities and that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms.This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.DASH Questionnaire will be calculated by using DASH Scoring Formula	at sixth months after surgery
Secondary	Second Functional Assessment	2. The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is used to measure shoulder pain and functional limitations.The scores range from 0 to 100 and the highest score represents improvement in shoulder function after treatment interventions and to check the patient's ability to tolerate or perform the activities of daily living.	at sixth months after surgery
Secondary	Third Functional Assessment	3. Constant-Murley Shoulder Score (CONSTANT) is a 100-points scale composed of individual parameters.These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.The Constant Score was introduced to determine the functionality after the treatment of a shoulder injury.The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion (40 points).The higher the score, the higher the quality of the function.	at sixth months after surgery