Health TrialsbyHealthPanel

RCT Evaluating First Time Shoulder Dislocation

ConditionsShoulder DislocationSport InjuryAnterior Dislocation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-40
SponsorMcMaster University

About this trial

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-operative management on the risk of recurrent anterior dislocation rates and functional outcomes following in patients presenting with a first-time dislocation (FTD) over a 24-month period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 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.

Disqualifiers

Patients that cannot undergo surgery or anesthesia;

Patients with concomitant injuries (rotator cuff tear, fracture)

Previous shoulder surgery;

Patients that will likely have problems with maintaining follow-up or are incarcerated;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bankart + Remplissage Procedure

    Procedure/Surgery

    Participants will undergo arthroscopic stabilization.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Bankart repair + Remplissage (randomized cohort)Experimental treatment 1 intervention
Group B: Conservative treatment (randomized cohort)No intervention 0 interventions
Group C: Bankart repair + Remplissage (non-randomized cohort)Experimental treatment 1 intervention
Group D: Conservative treatment (non-randomized cohort)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recruitment Feasibility

Number of patients recruited

Time frame
10 months
2

Follow-up

Proportion of participants followed at two years

Time frame
2 years
3

Surgery within 3 months of enrollment

Ability to operate on patients within 3 months following enrollment

Time frame
3 months
4

Crossovers

Assessment of crossovers between groups

Time frame
2 years

Secondary outcomes

1

Rate of Recurrence Dislocation

Rate of recurrent dislocation between patients randomized to arthroscopic surgical repair and those receiving conservative treatment.

Time frame
2 years
2

Rate of Instability

Rate of symptomatic instability/positive apprehension sign between patients randomized to arthroscopic surgical repair and those receiving conservative treatment.

Time frame
2 years
3

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).

Time frame
2 years
4

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

Source ClinicalTrials.gov
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