Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft

NCT03060564 | Unknown

• 1 other identifier: Pro46696
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate patient function, radiographic changes and complication rates of acute coracoclavicular (CC) joint reconstruction with and without the use of tendon graft as an augmentation to repair.

Conditions

Acromioclavicular Joint Dislocation

Keywords

shoulder; orthopaedics

Outcome Measures

Primary Outcomes (7)

• Complication Rates with and without the use of graft tendons

  loss of radiographic reduction, infection, need for more surgery

  2 years

• (American Shoulder Elbow Society (ASES)

  Shoulder Function survey (17 multiple choice questions).

  2 years

• Instability Index Constant Score (ISIS)

  Shoulder Instability survey for last 4 weeks (yes/no and multiple choice). Score is graded poor, fair, good, excellent.

  2 years

• Simple Shoulder Test (SST)

  Shoulder Function survey (12 yes/no questions)

  2 years

• Short Form-12

  This survey assesses patient's health satisfaction. This information will help keep track of how patients feel and how well patients are able to do your usual activities. (12 multiple choice questions)

  2 years

• Single Assessment Numerical Evaluation (SANE)

  Patient assessment rating from 0-100 shoulder normality

  2 years

• Visual Analog Score (VAS)

  Measurement of shoulder pain from 0 (no pain) to 10 (unbearable distress)

  2 years

Study Arms (2)

AC repair with tendon graft

EXPERIMENTAL

acromioclavicular repair with tendon graft.

Procedure: tendon graft

AC repair with no tendon graft

ACTIVE COMPARATOR

acromioclavicular repair without tendon graft/no intervention

Other: No intervention

Interventions

tendon graft PROCEDURE

JRF Orthopedics Tendon Graft

AC repair with tendon graft

No intervention OTHER

No intervention

AC repair with no tendon graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Displaced acromioclavicular joint dislocation sustained within 3 weeks of surgery
• recommended for operative fixation
• age 18 years or older

You may not qualify if:

• Open dislocation
• previous acromioclavicular surgery
• unable to follow study protocol
• concomitant injury requiring surgery (rotator cuff repair, biceps tenotomy/tenodesis)
• active infection
• unable to follow postoperative rehabilitation guidelines
• reconstruction with coracoclavicular screw or hook plate.

Sponsors & Collaborators

• Dr. Brian Lee: lead
• Cedars-Sinai Medical Center: collaborator
• Kerlan-Jobe Institute: collaborator
• White Memorial Hospital: collaborator

Study Sites (1)

Cedars-Sinai Kerlan-Jobe Institute at White Memorial Hospital

Los Angeles, California, 90033, United States

RECRUITING

Study Officials

• Brian Lee, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

3104233198; Christopher.Klein@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: orthopedic surgeon specializing in arthroscopic and open surgery of all conditions of the shoulder and elbow including arthritis, tendon disorders, fractures, and instability

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 23, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: September 1, 2019
• Last Updated: January 29, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)