Accelerated Rehabilitation After Arthroscopic Bankart Repair Surgery

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.

Study Overview

• Status: Completed
• Conditions: Bankart Lesion
• Intervention / Treatment: Other: Accelerated rehabilitation; Other: Delayed rehabilitation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: accelerated rehabilitation after surgery; patients were included progressive rehabilitation programme first week after arthroscopic bankart repair consisting of passive shoulder range of motion exercises, scapular retraction exercises. The exercise programme progressed from active range of motion exercises to resistive and plyometric shoulder exercises. Patients were followed for six months.	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
Experimental: delayed rehabilitation after surgery; Patients were not allowed to start passive shoulder exercises first three weeks after surgery. Patients were included progressive rehabilitation programme third week after arthroscopic bankart repair consisting of passive shoulder range of motion exercises, scapular retraction exercises. The exercise programme progressed from active range of motion exercises to resistive and plyometric shoulder exercises. Patients were followed for six months.	Other: Delayed rehabilitation; Patients were not allowed to start rehabilitation programme first three weeks after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Actual): March 15, 2018
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: shoulder; bankart repair; accelerated rehabilitation
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Shoulder Injuries; Shoulder Fractures; Bankart Lesions
• Other Study ID Numbers: GO 16/471-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No