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RCT Evaluating First Time Shoulder Dislocation (REDUCE)

Primary Purpose

Shoulder Dislocation, Sport Injury, Anterior Dislocation

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bankart + Remplissage Procedure
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation

Eligibility Criteria

14 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men and women ages 14-40 years; Diagnosis of first-time shoulder anterior dislocation having occurred within the past 3 months confirmed either by radiographic evidence or documented reduction of anterior shoulder dislocation as well as physical examination eliciting unwanted glenohumeral translation with reproduction of symptoms; Provision of informed consent. Exclusion Criteria: Patients that cannot undergo a surgery or undergo anesthesia; Patients with concomitant injuries (rotator cuff tear, fracture) or previous shoulder surgery; Patients that will likely have problems with maintaining follow-up; or are incarcerated. Epilepsy/seizure disorder, pregnancy Diagnosis of multidirectional instability, or glenoid bone loss as confirmed by radiographs; Dislocation without trauma, in a context of hyper laxity or atraumatic instability; Cases involving litigation or workplace insurance claims (e.g., WSIB).

Sites / Locations

  • St. Joseph's Healthcare HamiltonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bankart repair + Remplissage

Conservative treatment

Arm Description

Arthroscopic repair of anterior capsulo-labral structures

Non surgical intervention

Outcomes

Primary Outcome Measures

Recruitment Feasibility
Number of patients recruited
Follow-up
Proportion of participants followed at two years
Surgery within 3 months of enrollment
Ability to operate on patients within 3 months following enrollment
Blinded outcome adjudication of recurrent dislocation
Ability to perform blinded outcome adjudication of recurrent dislocation event (with collected source documents)
Rate of crossovers
Assessment of crossovers from control to intervention.

Secondary Outcome Measures

Rate of Recurrence Dislocation
Rate of recurrent dislocation between patients randomized to arthroscopic surgical repair and those receiving conservative treatment.
Rate of Instability
Rate of symptomatic instability/positive apprehension sign between patients randomized to arthroscopic surgical repair and those receiving conservative treatment.
Clinical Outcome - shoulder function
Measured by Western Ontario Shoulder Instability (WOSI) Index. 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).
Clinical Outcome
Measured by American Shoulder and Elbow Society (ASES) score. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Clinical Outcome - Quality of Life
Measured by EQ-5D (EuroQol-5 Dimension). The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem. A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Clinical Outcome - shoulder activity
Measured by Shoulder Activity Scale.The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points).
Clinical Outcome - pain
Measured by Visual Analog Scale (VAS) Pain Score. 0 - no pain, 10 - the worst pain
Clinical Outcome - patient satisfaction
Measured by Patient Satisfaction questionnaire. 0 - least satisfied, 10 - most satisfied
Rate of participants with full range of motion
Assessed in forward flexion, abduction, external rotation and internal rotation.
Rate of participants with risk of having recurrent shoulder instability
Measured by apprehension-relocation physical examination maneuver (positive or negative)
Rate of participants that return to previous level of activity
Return to previous level of activity and sport (self reported)
Return to work
Duration of work stoppage if applicable
Adverse events
Rate of major and minor shoulder-related complications and serious adverse events

Full Information

First Posted
January 18, 2023
Last Updated
October 18, 2023
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT05715021
Brief Title
RCT Evaluating First Time Shoulder Dislocation
Acronym
REDUCE
Official Title
Randomized Trial Evaluating First Time Shoulder Dislocation: Surgery vs Conservative Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2023 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster 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 primary objective of the pilot study is to assess the feasibility of a definitive trial to determine the effect of arthroscopic soft tissue stabilization vs. non-surgical intervention on the risk of recurrent anterior dislocation rates and functional outcomes following in patients presenting with a first-time dislocation (FSD) over a 24-month period.
Detailed Description
Background The shoulder is the most commonly dislocated joint in the body with a global incidence that ranges from 15 to 25 per 100 000 people. It is estimated that approximately 70 000 shoulder dislocations occur annually in the United States. In North America, a sampling of individuals presenting with shoulder dislocations to US emergency departments identified an overall incidence rate in the United States of 24 (95% confidence interval, 20.8 to 27.0) per 100,000 person-years and a maximum incidence rate (47.8 [95% confidence interval, 41.0 to 54.5]) occurring in those between the ages of twenty and twenty-nine years. A review of shoulder reductions performed in emergency rooms in Ontario, Canada between 2002 and 2010 identified 719 dislocations affecting primarily young patients with a median age of 35 years and 74% male. The incidence density rate of shoulder dislocations was found to be 23/100,000 person-years and highest among young males (98/100,000 person-years). Recurrence mainly occurs in the first 2 years after the first anterior shoulder dislocation event, and recurrent instability significantly affects quality of life, sport, and professional activities.4 Epidemiologic data suggests that younger patients are at significantly higher the risk of recurrence. In a prospective study of 252 patients by Robinson et al, the recurrence rate after 5 years reached 86.6% in patients aged 15 to 20 years, 73.8% in patients between 21 and 25 years of age, and 46.8% in patients between 26 and 30 years of age. Participation in contact and overhead throwing sports and higher sporting levels also increases the risk of recurrence. Management options in patients with a first-time shoulder dislocation include non-operative and operative approaches. Anterior dislocations often injure the anterior and inferior glenoid labrum, described as the Bankart lesion. This lesion was observed arthroscopically in 94% to 100% of patients and often result in long-term instability. Thus, there is debate as to whether arthroscopic Bankart repair should be routinely performed in patients after a first-time anterior shoulder dislocation. Historically, non-operative treatment has been the most common method of managing first-time dislocations. Additionally, for young athletes, non-operative treatment is often advocated in season to allow for rapid return to sport despite concerns regarding recurrent instability. Owens et al. demonstrated that non-operative management of an in-season shoulder dislocation can allow a return to sports in as little as 7 to 21 days, however early return increased the risk for further instability episodes, particularly in throwing or overhead athletes. Another study found that although 88.6% of 15- to 25- year-old athletes undergoing non-operative management returned to sport, 71.4% experienced recurrent dislocations. Given recent research and limited available evidence over the past 10 years, surgical management has been suggested as a potentially more reliable method to prevent further dislocations and improve patient outcomes when compared with non-operative management. Arthroscopic soft tissue repair (Bankart repair) has become increasingly popular given the advancement in surgical technique allowing for a minimally invasive and reliable improvement in instability with a low risk of complication. The high recurrence rate in younger patients may justify offering surgical treatment after the first episode of FTD. A recent systematic review by Hurley et al. found arthroscopic Bankart repair resulted in a 7-fold lower recurrence rate and a higher rate of return to play than conservative management. Current surgical practice however is generally consideration for surgical management only if further instability or recurrence has occurred. Recurrence however increases a patient's risk of further injury to the humeral head and glenoid - potentially resulting in poorer outcomes. Although some studies show arthroscopic treatment after first episodes of FTD in younger patients results in low dislocation rates, such treatment is not universally recognized or practiced. Additionally, concern regarding overtreatment exists - a network meta-analysis by Kavaja et al. found for patients 47% of patients receiving non-surgical management did not experience further shoulder dislocations. Significant controversy therefore exists regarding optimal management of this widespread condition. Need for a Pilot Study Prior to a Large Trial A pilot study is needed prior to a large trial to determine the feasibility of a larger trial in terms of ability to recruit across clinical sites, adherence to study protocol and ability to follow participants for 24 months. Primary objective is to examine the feasibility of a larger trial. Feasibility objectives include: Ability to recruit across multiple clinical sites. Ability to follow participants for 24 months. Ability to operate on patients within 3 months following enrollment. Ability to perform blinded outcome adjudication of recurrent dislocation event (with collected source documents) Assessment of crossovers from control to intervention. Secondary objectives: compare arthroscopic capsuloligamentous repair vs. non-surgical intervention on: Recurrent shoulder dislocations up to 24 months' post-treatment. Symptoms of instability without dislocation up to 24 months post treatment. Clinical outcomes measured by Western Ontario Shoulder Instability (WOSI) Index, American Shoulder and Elbow Society (ASES) score, Shoulder Activity Scale, EQ-5D, Visual Analog Scale (VAS) Pain Score, and Patient Satisfaction questionnaire. Physical examination: range of motion, stability, strength, presence of apprehension. Return to previous level of activity and work. Safety, shoulder-related complications and serious adverse events. The investigators propose a multi-centre pilot RCT of 50 participants across Canada, United States, South America and/or Europe to compare the effect of arthroscopic capsuloligamentous repair (Bankart procedure) and conservative treatment (non-surgical intervention) in patients with a post-traumatic first-time shoulder anterior dislocation. Eligible and consenting participants will be followed-up by the site for 24 months. Outcomes will be assessed at 6 weeks, 6 months, 12 months, and 24 months post-treatment. Eligible participants will be randomized to one of two treatment groups: Arthroscopic capsuloligamentous repair (Bankart + Remplissage Procedure) Conservative treatment (non surgical intervention) Once participants have provided informed consent, baseline demographics, relevant medical history, and details regarding their diagnosis will be collected from the participant, the attending surgeon, their medical record and through physical examination. Participants will also complete The Western Ontario Shoulder Instability Index (WOSI), the American Shoulder and Elbow Surgeons questionnaire (ASES), EQ-5D, patient satisfaction scale at the time of enrolment. After surgery, surgical and peri-operative details will be collected from the attending surgeon and the participant's medical records. Adverse events occurring during the surgical procedure or perioperative period will also be documented.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation, Sport Injury, Anterior Dislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bankart repair + Remplissage
Arm Type
Experimental
Arm Description
Arthroscopic repair of anterior capsulo-labral structures
Arm Title
Conservative treatment
Arm Type
No Intervention
Arm Description
Non surgical intervention
Intervention Type
Procedure
Intervention Name(s)
Bankart + Remplissage Procedure
Intervention Description
Participants will undergo arthroscopic stabilization.
Primary Outcome Measure Information:
Title
Recruitment Feasibility
Description
Number of patients recruited
Time Frame
10 months
Title
Follow-up
Description
Proportion of participants followed at two years
Time Frame
2 years
Title
Surgery within 3 months of enrollment
Description
Ability to operate on patients within 3 months following enrollment
Time Frame
3 months
Title
Blinded outcome adjudication of recurrent dislocation
Description
Ability to perform blinded outcome adjudication of recurrent dislocation event (with collected source documents)
Time Frame
2 years
Title
Rate of crossovers
Description
Assessment of crossovers from control to intervention.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Rate of Recurrence Dislocation
Description
Rate of recurrent dislocation between patients randomized to arthroscopic surgical repair and those receiving conservative treatment.
Time Frame
2 years
Title
Rate of Instability
Description
Rate of symptomatic instability/positive apprehension sign between patients randomized to arthroscopic surgical repair and those receiving conservative treatment.
Time Frame
2 years
Title
Clinical Outcome - shoulder function
Description
Measured by Western Ontario Shoulder Instability (WOSI) Index. 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).
Time Frame
2 years
Title
Clinical Outcome
Description
Measured by American Shoulder and Elbow Society (ASES) score. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Time Frame
2 years
Title
Clinical Outcome - Quality of Life
Description
Measured by EQ-5D (EuroQol-5 Dimension). The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem. A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Time Frame
2 years
Title
Clinical Outcome - shoulder activity
Description
Measured by Shoulder Activity Scale.The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points).
Time Frame
2 years
Title
Clinical Outcome - pain
Description
Measured by Visual Analog Scale (VAS) Pain Score. 0 - no pain, 10 - the worst pain
Time Frame
2 years
Title
Clinical Outcome - patient satisfaction
Description
Measured by Patient Satisfaction questionnaire. 0 - least satisfied, 10 - most satisfied
Time Frame
2 years
Title
Rate of participants with full range of motion
Description
Assessed in forward flexion, abduction, external rotation and internal rotation.
Time Frame
2 years
Title
Rate of participants with risk of having recurrent shoulder instability
Description
Measured by apprehension-relocation physical examination maneuver (positive or negative)
Time Frame
2 years
Title
Rate of participants that return to previous level of activity
Description
Return to previous level of activity and sport (self reported)
Time Frame
2 years
Title
Return to work
Description
Duration of work stoppage if applicable
Time Frame
2 years
Title
Adverse events
Description
Rate of major and minor shoulder-related complications and serious adverse events
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women ages 14-40 years; Diagnosis of first-time shoulder anterior dislocation having occurred within the past 3 months confirmed either by radiographic evidence or documented reduction of anterior shoulder dislocation as well as physical examination eliciting unwanted glenohumeral translation with reproduction of symptoms; Provision of informed consent. Exclusion Criteria: Patients that cannot undergo a surgery or undergo anesthesia; Patients with concomitant injuries (rotator cuff tear, fracture) or previous shoulder surgery; Patients that will likely have problems with maintaining follow-up; or are incarcerated. Epilepsy/seizure disorder, pregnancy Diagnosis of multidirectional instability, or glenoid bone loss as confirmed by radiographs; Dislocation without trauma, in a context of hyper laxity or atraumatic instability; Cases involving litigation or workplace insurance claims (e.g., WSIB).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Garrido Clua, MSc
Phone
905-522-1155
Ext
32953
Email
mgarrido@stjoes.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Moin Khan, MD
Phone
905-522-1155
Ext
32953
Email
khanmm2@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moin Khan, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Garrido Clua, MSc
Email
mgarrido@stjoes.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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RCT Evaluating First Time Shoulder Dislocation

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