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

NCT05250388 | Recruiting

• 1 other identifier: H-21027799
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 patient-reported and clinical outcomes. 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 the intervention leads to improved patient-reported and clinical outcomes.

Conditions

Shoulder Dislocation

Keywords

Traumatic anterior shoulder instability; Shoulder dislocation; Glenohumeral instability; Glenohumeral biomechanics; Shoulder biomechanics; Glenohumeral translation

Outcome Measures

Primary Outcomes (1)

• Change in anterior-posterior glenohumeral translation (range in millimeters)

  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.

  baseline, 6 months

Secondary Outcomes (4)

• Change in anterior-posterior glenohumeral translation (range in millimeters)

  baseline, 12 months

• Change in neuromuscular control (as assessed with the Copenhagen Assessment of Neuromuscular Control in the Unstable Shoulder (CANCUS) protocol).

  baseline, 6 months, 12 months

• Change in superior-inferior glenohumeral translation (range in millimeters)

  baseline, 6 months, 12 months

• Change in scapular rotations (degrees)

  baseline, 6 months, 12 months

Other Outcomes (6)

• Instability tests

  baseline, 6 months, 12 months

• Change in Western Ontario Shoulder Instability (WOSI) Index

  baseline, 6 months, 12 months

• Change in EQ-5D(-5L) questionnaire on quality of life

  baseline, 6 months, 12 months

Study Arms (1)

Patient group

Patients aged 18-40 years with symptomatic unilateral traumatic anterior shoulder instability, following radiographically confirmed or manually reduced dislocation (first-time or recurrent), scheduled for arthroscopic Bankart repair, and with no pathology in the contralateral shoulder. 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

Interventions

Arthroscopic Bankart repair PROCEDURE

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.

Patient group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients aged 18-40 years with unilateral symptomatic traumatic anterior shoulder instability undergoing arthroscopic Bankart repair

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catarina Malmberg: lead
• Køge Hospital: collaborator
• Herlev og Gentofte Hospital: collaborator
• Adeas Hospitaler: collaborator
• Gildhøj Privathospital: collaborator

Study Sites (1)

Dept. of Orthopedic Surgery, Copenhagen University Hospital Hvidovre

Hvidovre, Denmark

RECRUITING

Related Publications (2)

• Malmberg C, Andreasen KR, Bencke J, Kjaer BH, Holmihc P, Barfod KW. Reliability of ultrasound measurement of glenohumeral instability. Dan Med J. 2025 Oct 15;72(11):A11240835. doi: 10.61409/A11240835.

  PMID: 41133330 DERIVED

• Malmberg C, Andreasen KR, Bencke J, Kjaer BH, Holmich P, Barfod KW. Biomechanical and neuromuscular characteristics in patients with traumatic anterior shoulder instability undergoing arthroscopic Bankart repair: a clinical prospective cohort study protocol. BMJ Open. 2024 Mar 1;14(3):e078376. doi: 10.1136/bmjopen-2023-078376.

  PMID: 38431300 DERIVED

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Officials

• Catarina Malmberg, MD

  Dept. of Orthopedic Surgery, Copenhagen University Hospital Hvidovre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catarina Malmberg, MD

CONTACT

+45 27519524; catarina.anna.evelina.malmberg.02@regionh.dk

Kristoffer W Barfod, MD, Ph.d.

CONTACT

kbarfod@dadlnet.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 22, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)