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Arthroscopic Rotator Interval Closure in Shoulder Instability Repair

T

Tel Aviv Sourasky Medical Center

Status

Unknown

Conditions

Recurrent Shoulder Dislocations

Treatments

Procedure: Arthroscopic Bankart repair
Procedure: ABR+ARIC

Study type

Interventional

Funder types

Other

Identifiers

NCT00901797
Dr. Maman

Details and patient eligibility

About

Study Title: Arthroscopic rotator interval closure in shoulder instability repair - a prospective study

Objective: To evaluate the effect of arthroscopic rotator interval closure (ARIC) on patients with recurrent shoulder dislocations undergoing arthroscopic bankart repair (ABR) in terms of recurrence, rehabilitation and function.

Hypothesis:

  1. Although Hyperlax patients undergoing ABR have higher incidence of recurrent shoulder dislocations than those without hyperlaxity, adding ARIC will lower the recurrent dislocation rate.
  2. Patients with arthroscopic bankart repair (ABR) and ARIC are slower in gaining the range of motion (ROM) but within 6 months are equal to those with ABR only.

Enrollment

100 estimated patients

Sex

All

Ages

16 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 16-40 years old
  • Anterior Shoulder instability
  • Hyperlaxity (general and shoulder laxity)

Exclusion criteria

  • Previous humerus/glenoid fracture
  • large bony "Bankart"
  • Previous shoulder operation
  • Adhesive capsulitis-Habitual dislocations

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Arthroscopic Bankart repair
Active Comparator group
Treatment:
Procedure: Arthroscopic Bankart repair
ABR+ARIC
Active Comparator group
Treatment:
Procedure: ABR+ARIC

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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