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CompletedNCT03347019Updated Apr 21, 2020

Accelerated Rehabilitation After Arthroscopic Bankart Repair Surgery

An interventional study of Accelerated rehabilitation and Delayed rehabilitation in Bankart Lesion, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-04-21.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bankart Lesion

Keywords

  • bankart repair
  • accelerated rehabilitation
  • shoulder
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • patients with inflammatory, autoimmune, endocrine or kidney diseases
  • Recurrence
  • Bony Bankart Lesion
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherAccelerated 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

  • OtherDelayed rehabilitation

    Patients were not allowed to start rehabilitation programme first three weeks after surgery.

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: at sixth months after surgery

Secondary outcomes

  1. 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"

    Time frame: at sixth months after surgery

  2. 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

    Time frame: at sixth months after surgery

  3. 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.

    Time frame: at sixth months after surgery

  4. 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.

    Time frame: at sixth months after surgery

06

Study locations

1 site
  • Hacettepe University
    Ankara, 06100, Turkey
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03347019
Lead sponsor
Hacettepe University
Responsible party
Irem Duzgun (associate professor, Hacettepe University) — Principal investigator
First posted
Nov 20, 2017
Start date
Dec 15, 2016
Primary completion
Mar 15, 2018
Completion
Mar 15, 2019
Last update
Apr 21, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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