Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acromioclavicular Joint Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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AC repair with tendon graft

acromioclavicular repair with tendon graft.

Group Type EXPERIMENTAL

tendon graft

Intervention Type PROCEDURE

JRF Orthopedics Tendon Graft

AC repair with no tendon graft

acromioclavicular repair without tendon graft/no intervention

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type OTHER

No intervention

Interventions

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tendon graft

JRF Orthopedics Tendon Graft

Intervention Type PROCEDURE

No intervention

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Dr. Brian Lee

orthopedic surgeon specializing in arthroscopic and open surgery of all conditions of the shoulder and elbow including arthritis, tendon disorders, fractures, and instability

Responsibility Role SPONSOR_INVESTIGATOR