Clinical trial NCT03060564: Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft
Official title: A Randomized, Prospective Trial Comparing Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acromioclavicular Joint Dislocation
Keywords: shoulder
orthopaedics
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Cedars-Sinai Medical Center
name: Kerlan-Jobe Institute
name: White Memorial Hospital
First posted: 2017-02-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complication Rates with and without the use of graft tendons
timeFrame: 2 years
measure: (American Shoulder Elbow Society (ASES)
timeFrame: 2 years
measure: Instability Index Constant Score (ISIS)
timeFrame: 2 years
measure: Simple Shoulder Test (SST)
timeFrame: 2 years
measure: Short Form-12
timeFrame: 2 years
measure: Single Assessment Numerical Evaluation (SANE)
timeFrame: 2 years
measure: Visual Analog Score (VAS)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Kerlan-Jobe Institute at White Memorial Hospital
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Brian Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: