Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft

A Randomized, Prospective Trial Comparing Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft

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.

Study Overview

• Status: Unknown
• Conditions: Acromioclavicular Joint Dislocation
• Intervention / Treatment: Other: No intervention; Procedure: tendon graft

Detailed Description

Acromioclavicular (AC) joint dislocations comprise up to 12% of shoulder girdle injuries. Many methods of reconstructing the coracoclavicular ligaments, which provide vertical stability of the acromioclavicular joint, have been described. The use of tendon graft to augment the reconstruction provides improved biomechanical stability, less radiographic changes postoperatively including loss of reduction, and improved function. However, the use of a tendon graft necessitates larger drill holes in the clavicle when compared to suture-only repair constructs. The size and placement of these tunnels in the clavicle have been associated with a higher rate of complications.

It has been shown that repairs in the setting of acute injury demonstrate less complications including loss of reduction when compared with chronic dislocations. However, other reports describing repair of acute AC joint dislocations without graft augmentation have described significant changes in coracoclavicular distance with routine follow up radiographs, and up to 90% implant migration rates. While use of tendon graft would be expected to provide further stability, they may in turn cause an increased complication rate.

1. To determine complication rates in the reconstruction of AC joint dislocations with and without the use of tendon graft.
2. Determine patient satisfaction, the ASES, Constant, SF-12, SANE, SST scores of shoulders that undergo reconstruction of acute AC joint dislocations with and without the use of graft.
3. The investigation aims to determine whether or not graft should be used in the reconstruction of acute AC joint dislocations.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Cedars-Sinai Kerlan-Jobe Institute at White Memorial Hospital
      • Contact: Chris Kelin; Phone Number: 310-423-3198

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AC repair with tendon graft; acromioclavicular repair with tendon graft.	Procedure: tendon graft; JRF Orthopedics Tendon Graft
Active Comparator: AC repair with no tendon graft; acromioclavicular repair without tendon graft/no intervention	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dr. Brian Lee
• Collaborators: Cedars-Sinai Medical Center; Kerlan-Jobe Institute; White Memorial Hospital
• Investigators: Principal Investigator: Brian Lee, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: shoulder; orthopaedics
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations
• Other Study ID Numbers: Pro46696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes