The Effect of Arthroscopic Bankart Repair on Anterior-posterior Glenohumeral Translation and Shoulder Proprioception in Patients With Traumatic Anterior Shoulder Instability: a Prospective Cohort Study

Sponsor

Catarina Malmberg (Other)

Overall Status

Recruiting

CT.gov ID

NCT05250388

Collaborator

Køge Hospital (Other), Herlev og Gentofte Hospital (Other), Adeas Hospitaler (Other), Gildhøj Privathospital (Other)

Enrollment

Location

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to investigate biomechanical and proprioceptive conditions in patients with symptomatic traumatic anterior shoulder instability undergoing arthroscopic Bankart repair. To determine these, non-invasive and non-irradiating examination methods that have been proven valid and reliable will be used in a combination that has not been reported before. The objective is to determine whether the anatomical reconstruction affects biomechanical and proprioceptive measures in the traumatic unstable shoulder. The study will also investigate the correlations between biomechanics and proprioception and patients' functional outcomes and range of motion.

The hypotheses are that the intervention improves biomechanical and proprioceptive conditions to the near-normal state, as measured after both 6 and 12 months. Further, hypotheses are that there are positive correlations between improved biomechanical and proprioceptive measures and both patients' functional outcomes and range of motion.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Dislocation	Procedure: Arthroscopic Bankart repair

Detailed Description

• Aim: To investigate the effect of arthroscopic Bankart repair on shoulder biomechanics and proprioception, and increase understanding of traumatic anterior shoulder instability.

• Main research questions: A (biomechanics): Does arthroscopic Bankart repair have a stabilising effect on the anterior-posterior glenohumeral translation in patients with traumatic anterior shoulder instability? B (proprioception): Does arthroscopic Bankart repair improve neuromuscular control in patients with traumatic anterior shoulder instability?

• Objectives and hypotheses research question A: In patients with symptomatic traumatic anterior shoulder instability treated with arthroscopic Bankart repair in combination with a standardized rehabilitation protocol, to: Primary: Investigate if Bankart repair affects anterior-posterior glenohumeral translation, measured during dynamic and isometric exercises 6 months after surgery. Further, whether the effect remains 12 months after surgery. Hypothesis: The treatment results in a ≥2.5 mm decrease in anterior-posterior glenohumeral translation, remaining both 6 and 12 months after surgery.

Secondary: Investigate if the treatment reduces anterior-posterior glenohumeral translation to the same range as the healthy opposite shoulder (±2.5 mm). Hypothesis: The treatment reduces anterior-posterior glenohumeral translation to the same range as measured in the healthy opposite shoulder (±2.5 mm).

Secondary: Investigate if other kinematic measures (superior-inferior glenohumeral translation and scapular rotations and tilt) are affected 6 months after surgery. Hypothesis: The treatment reduces superior-inferior glenohumeral translation while scapular rotations and tilt remain unchanged 6 months after surgery.

Secondary: Investigate if there is a correlation between the range of anterior-posterior glenohumeral translation and 1) patient-reported outcome measures (PROM) and 2) range of motion (ROM). Hypotheses: There is a positive correlation between smaller range of anterior-posterior translation and better PROM. There is a positive correlation between smaller range of anterior-posterior translation and reduced ROM.

• Objectives and hypotheses research question B: In patients with symptomatic traumatic anterior shoulder instability, treated with arthroscopic Bankart repair in combination with a standardized rehabilitation protocol, to: Primary: Investigate if the treatment improves neuromuscular control, measured using the Copenhagen Assessment of Neuromuscular Control in the Unstable Shoulder (CANCUS) test series 6 months after surgery, and whether the improvement remains 12 months after surgery. Hypothesis: The treatment improves neuromuscular control, remaining both 6 and 12 months after surgery.

Secondary: Investigate if the treatment improves neuromuscular control to the same range as the healthy opposite shoulder. Hypothesis: The treatment improves neuromuscular control to the same range as the healthy opposite shoulder.

Secondary: To investigate if there is a correlation between the degree of improvement of neuromuscular control and 1) PROM and 2) ROM. Hypotheses: There is a positive correlation between the degree of improvement of neuromuscular control and better PROM. There is a positive correlation between the degree of improvement of neuromuscular control and larger ROM.

• Type of study: Multi-clinical prospective cohort study including 55 patients. Patients' contralateral shoulders will be used as controls.

• Time schedule: Recruitment and inclusion is planned to begin 1 March 2022 and is expected to last for twelve months. With a one-year follow-up the complete study period is expected to last two years.

• Set-up: Five sports orthopaedics clinics in the Capital Region of Denmark will recruit patients for the study. While the responsibility for treatment remains at the recruiting center, all study-related activities will take place at the Copenhagen University Hospital Hvidovre. Patients who have signed an informed consent form will undergo examinations prior to, as well as six and twelve months after surgery. All examinations will include biomechanical and proprioceptive testing, accompanied by a clinical shoulder examination and two validated electronic questionnaires regarding shoulder-related function and quality of life. A pre-interventional 3D computed tomography scan will be performed to evaluate bone loss. Study participation will not influence the treatment course.

Study Design

Study Type:

Observational

Anticipated Enrollment :

55 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Effect of Arthroscopic Bankart Repair on Anterior-posterior Glenohumeral Translation and Shoulder Proprioception in Patients With Traumatic Anterior Shoulder Instability: a Prospective Cohort Study

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patient group Patients aged 18-40 years with symptomatic unilateral traumatic anterior shoulder instability, due to dislocation or subluxation, scheduled for arthroscopic Bankart repair. The study is not interventional but observational, examining biomechanical and proprioceptive conditions in patients' unstable shoulders before and after the surgical procedure.	Procedure: Arthroscopic Bankart repair Arthroscopic Bankart repair is a minimally invasive surgical procedure with the aim to reattach and tighten the detached labrum and ligaments within the shoulder joint.

Arm

Intervention/Treatment

Patient group

Patients aged 18-40 years with symptomatic unilateral traumatic anterior shoulder instability, due to dislocation or subluxation, scheduled for arthroscopic Bankart repair. The study is not interventional but observational, examining biomechanical and proprioceptive conditions in patients' unstable shoulders before and after the surgical procedure.

Procedure: Arthroscopic Bankart repair

Arthroscopic Bankart repair is a minimally invasive surgical procedure with the aim to reattach and tighten the detached labrum and ligaments within the shoulder joint.

Outcome Measures

Primary Outcome Measures

Change in anterior-posterior glenohumeral translation (range in millimeters) [baseline, 6 months]
The effect of Bankart repair on anterior-posterior glenohumeral translation, measured 6 months after intervention and compared to pre-interventional. The translation will be measured using ultrasound examination.
Change in neuromuscular control (as assessed with the Copenhagen Assessment of Neuromuscular Control in the Unstable Shoulder (CANCUS) protocol). [baseline, 6 months]
The effect of Bankart repair on neuromuscular control 6 months after intervention and compared to pre-interventional. Neuromuscular control will be assessed using the Copenhagen Assessment of Neuromuscular Control in the Unstable Shoulder (CANCUS) protocol.

Secondary Outcome Measures

Change in anterior-posterior glenohumeral translation (range in millimeters) [baseline, 12 months]
Longer-term effects of Bankart repair on anterior-posterior glenohumeral translation, as measured 12 months after intervention and compared to pre-interventional. The translation will be measured using ultrasound examination.
Change in neuromuscular control [baseline, 12 months]
Longer-term effects of Bankart repair on neuromuscular control, as measured 12 months after intervention and compared to pre-interventional. Neuromuscular control will be assessed using the Copenhagen Assessment of Neuromuscular Control in the Unstable Shoulder (CANCUS) protocol.
Change in superior-inferior glenohumeral translation (range in millimeters) [baseline, 6 months, 12 months]
Effects of Bankart repair on superior-inferior glenohumeral translation, measured 6 and 12 months after intervention and compared to pre-interventional.
Change in scapular rotations (degrees) [baseline, 6 months, 12 months]
Effects of Bankart repair on scapular rotations, measured 6 and 12 months after intervention and compared to pre-interventional.
Change in Western Ontario Shoulder Instability (WOSI) Index [baseline, 6 months, 12 months]
The Western Ontario Shoulder Instability (WOSI) Index is a patient-reported outcome measure (PROM). It consists of 21 items, each scored on a 100mm Visual Analogue Scale (VAS). Each item falls into one of the domains of physical function, sports/recreation/work, lifestyle and emotional well-being. Each question is scored between 0-100 points and the summation of all the questions results in a final WOSI score. The final score ranges from 0 (best possible score - the patient is experiencing no decrease in shoulder-related quality of life) to 2100 (worst score - signifies extreme distress in shoulder-related quality of life).
Change in EQ-5D(-5L) questionnaire on quality of life [baseline, 6 months, 12 months]
The EQ-5D-5L questionnaire on quality of life is a patient-reported outcome measure (PROM), with five components, which assess the severity of problems in three functional dimensions (mobility, self-care, and usual activities) and two somatic symptom dimensions (pain/discomfort and anxiety/depression). The response scales consist of a heading and five short statements, each describing a different level of severity within the dimensions.
Change in degrees of shoulder range of motion [baseline, 6 months, 12 months]
Range of motion will be assessed clinically as degrees from anatomical position in the following planes: flexion, extension, abduction, adduction, internal and external rotation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-40 years
Unilateral traumatic anterior shoulder instability booked for arthroscopic Bankart repair according to the department's guidelines (extent of symptoms, suffer recurrent dislocations, positive apprehension and relocation test, limited bone loss)
Willing to adhere to the study protocol, herein attend follow-up
The patient must be able to speak and understand Danish
The patient must be able to give written informed consent

Exclusion Criteria:

Traumatic instability in the opposite shoulder
For one or both shoulders: posterior, multi-directional or atraumatic instability
For one or both shoulders: traumatic rotator cuff or biceps tendon tear, Superior Labrum from Anterior to Posterior tear (SLAP-lesion)
For one or both shoulders: traumatic fracture of proximal humerus (other than Hill-Sachs lesion), clavicula, scapula (other than glenoid) or dislocation of sternoclavicular or acromioclavicular joints
For one or both shoulders: atraumatic shoulder pathologies (e.g. frozen shoulder, symptomatic osteoarthritis of the shoulder or acromioclavicular joints, acute calcific tendinitis)
Pregnancy
Terminal illness or severe medical illness: American Society of Anesthesiology (ASA) score ≥3.