Clinical trial NCT00901797: Arthroscopic Rotator Interval Closure in Shoulder Instability Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Shoulder Dislocations
Keywords: ABD
ABDuction
ABR
Arthroscopic Bankart Repair
ACJ
AcromioClavicular Joint
AD
Anterior Drawer
ARIC
Arthroscopic Rotator Interval Closure
BL
Bankart Lesion
CHL
CoracoHumeral Ligament
ER
External Rotation
FF
Forward Flexion
GHJ
GlenoHumeral Joint
HSL
HillSacs Lesion
IR
Internal Rotation
ISP
InfraSPinatus
PD
Posterior Drawer
RI
Rotator Interval
ROM
Range Of Motion
SGHL
Superior GlenoHumeral Ligament
SSC
SubSCapularis
SSP
SupraSPinatus
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-05-14
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recurrent shoulder dislocation or instability symptoms
timeFrame: Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up.
Secondary outcomes:
measure: Post operative range of motion (ROM)
timeFrame: Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up.
measure: Activity level
timeFrame: Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up.
measure: Need for recurrent surgery
timeFrame: Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up.
measure: Pain
timeFrame: Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up.
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Shoulder Unit, Orthopedics B Department, Tel Aviv medical center
city: Tel-Aviv
country: Israel
facility: TelAviv Suraski Medical Center
Study officials:
References:
citation: Stokes DA, Savoie FH 3rd, Field LD, Ramsey JR. Arthroscopic repair of anterior glenohumeral instability and rotator interval lesions. Orthop Clin North Am. 2003 Oct;34(4):529-38. doi: 10.1016/s0030-5898(03)00091-9.
citation: Provencher MT, Mologne TS, Hongo M, Zhao K, Tasto JP, An KN. Arthroscopic versus open rotator interval closure: biomechanical evaluation of stability and motion. Arthroscopy. 2007 Jun;23(6):583-92. doi: 10.1016/j.arthro.2007.01.010.