Skip to content

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03060564
Enrollment
150
Registered
2017-02-23
Start date
2017-03-01
Completion date
2019-09-30
Last updated
2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromioclavicular Joint Dislocation

Keywords

shoulder, orthopaedics

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.

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.

Interventions

PROCEDUREtendon graft

JRF Orthopedics Tendon Graft

OTHERNo intervention

No intervention

Sponsors

Cedars-Sinai Medical Center
CollaboratorOTHER
Kerlan-Jobe Institute
CollaboratorUNKNOWN
White Memorial Hospital
CollaboratorUNKNOWN
Dr. Brian Lee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Score (VAS)2 yearsMeasurement of shoulder pain from 0 (no pain) to 10 (unbearable distress)
Complication Rates with and without the use of graft tendons2 yearsloss of radiographic reduction, infection, need for more surgery
(American Shoulder Elbow Society (ASES)2 yearsShoulder Function survey (17 multiple choice questions).
Instability Index Constant Score (ISIS)2 yearsShoulder Instability survey for last 4 weeks (yes/no and multiple choice). Score is graded poor, fair, good, excellent.
Simple Shoulder Test (SST)2 yearsShoulder Function survey (12 yes/no questions)
Short Form-122 yearsThis 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)
Single Assessment Numerical Evaluation (SANE)2 yearsPatient assessment rating from 0-100 shoulder normality

Countries

United States

Contacts

Primary ContactStudy Coordinator
Christopher.Klein@cshs.org3104233198

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026