Back to resultsAccelerated Rehabilitation After Arthroscopic Bankart Repair Surgery
Primary Purpose
Bankart Lesion
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Accelerated rehabilitation
Delayed rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Bankart Lesion focused on measuring bankart repair, accelerated rehabilitation, shoulder
Eligibility Criteria
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
Sites / Locations
- Hacettepe University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
accelerated rehabilitation after surgery
delayed rehabilitation after surgery
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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"
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03347019
Brief Title
Accelerated Rehabilitation After Arthroscopic Bankart Repair Surgery
Official Title
Accelerated Rehabilitation After Arthroscopic Bankart Repair Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 15, 2016 (Actual)
Primary Completion Date
March 15, 2018 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bankart Lesion
Keywords
bankart repair, accelerated rehabilitation, shoulder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
accelerated rehabilitation after surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
delayed rehabilitation after surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Accelerated rehabilitation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Delayed rehabilitation
Intervention Description
Patients were not allowed to start rehabilitation programme first three weeks after surgery.
Primary Outcome Measure Information:
Title
3 Dimensional Kinematic Analysis
Description
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).
Time Frame
at sixth months after surgery
Secondary Outcome Measure Information:
Title
Pain Assessment
Description
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"
Time Frame
at sixth months after surgery
Title
First Functional Assessment
Description
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
Time Frame
at sixth months after surgery
Title
Second Functional Assessment
Description
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.
Time Frame
at sixth months after surgery
Title
Third Functional Assessment
Description
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.
Time Frame
at sixth months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Accelerated Rehabilitation After Arthroscopic Bankart Repair Surgery
We'll reach out to this number within 24 hrs