Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft

Acromioclavicular Joint Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03060564
• Other study ID #: Pro46696
• Status: Recruiting
• Phase: N/A
• First received: February 7, 2017
• Last updated: January 26, 2018
• Start date: March 1, 2017
• Est. completion date: September 2019

Study information

• Verified date: January 2018
• Source: Cedars-Sinai Medical Center
• Contact: Study Coordinator
• Phone: 3104233198
• Email: Christopher.Klein[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acromioclavicular Joint Dislocation

Intervention

Procedure:
• tendon graft
JRF Orthopedics Tendon Graft

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
United States	Cedars-Sinai Kerlan-Jobe Institute at White Memorial Hospital	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
Dr. Brian Lee	Cedars-Sinai Medical Center, Kerlan-Jobe Institute, White Memorial Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication Rates with and without the use of graft tendons	loss of radiographic reduction, infection, need for more surgery	2 years
Primary	(American Shoulder Elbow Society (ASES)	Shoulder Function survey (17 multiple choice questions).	2 years
Primary	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
Primary	Simple Shoulder Test (SST)	Shoulder Function survey (12 yes/no questions)	2 years
Primary	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
Primary	Single Assessment Numerical Evaluation (SANE)	Patient assessment rating from 0-100 shoulder normality	2 years
Primary	Visual Analog Score (VAS)	Measurement of shoulder pain from 0 (no pain) to 10 (unbearable distress)	2 years