Clinical trial NCT05146791: Clinical and Radiographic Outcomes in Arthroscopic Cuistow Procedure and Arthroscopic Modified Bristow Procedure
Official title: Clinical and Radiographic Outcomes in Arthroscopic Cuistow Procedure and Arthroscopic Modified Bristow Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Dislocation
Keywords: Bristow
shoulder dislocation
Inlay
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients undergoing the Cuistow procedure and modified Bristow procedure in our hospital between Jan 2017 and Mar 2018.

Brief summary: To evaluate the clinical and radiographic outcomes of arthroscopic Chinese Unique Inlay Bristow procedure (Cuistow procedure) and arthroscopic Bristow procedure in treating recurrent anterior shoulder instability.

Detailed description: Aim: To compare the clinical and radiographic outcomes following the arthroscopic Chinese Unique Inlay Bristow (Cuistow) procedure and the arthroscopic Bristow procedure.

Background: The Cuistow procedure is a modified Bristow surgery in which a Mortise and Tenon structure was added to the contact surface between the coracoid tip and the glenoid. In previous study, patients received Cuistow procedure have satisfying clinical performance and excellent postoperative bone healing rate (96.1%). However, no comparative studies was performed.

Study Design: Retrospective comparative case-cohort study

Methods: Patients who underwent the arthroscopic Cuisotw procedure and modified Bristow procedure between Jan 2017 and Mar 2018 were selected. 70 patients with recurrent anterior shoulder instability were included. Radiological evaluations with 3D CT scan were performed preoperatively, immediately after the operation, and postoperatively at three months and during the final follow-up (more than 2 years). Clinical assessment for a minimum of 24 months including the 10-point visual analog scale for pain and subjective instability, University of California at Los Angeles scoring system (UCLA score), American Shoulder and Elbow Surgeons score (ASES score), ROWE score, Subjective Shoulder Value (SSV) and active range of motion were completed by independent observers and analyzed.

Eligibility criteria: Inclusion Criteria:

1. a glenoid defect ≥10% but \<25%,
2. participation in high-demand (collision and overhead) sports combined with the presence of a glenoid defect \<25% of the glenoid or without defect
3. failure after Bankart repair.

Exclusion Criteria:

1. multidirectional shoulder instability (MDI),
2. uncontrolled epilepsy
3. pathological involvement of other soft tissue such as the long head of the biceps or a rotator cuff tear
4. previous shoulder stability surgery other than Bankart repair
5. Follow-up was less than 2 years or incomplete follow-up data.

Primary outcomes:
measure: Bone union rate
timeFrame: 3-month postoperatily
measure: Bone union rate
timeFrame: 2-year postoperatily
measure: ASES score
timeFrame: 2-year postoperatively
Secondary outcomes:
measure: dislocation rate
timeFrame: 2-year postoperatively
measure: VAS for pain score
timeFrame: 2-year postoperatively
measure: Active shoulder ranges of motion
timeFrame: 2-year postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: PekingUTH
state: Beijing
Study officials:
References: