NCT03060564

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Dr. Brian Lee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acromioclavicular Joint Dislocation

Interventions

Type	Name	Description
PROCEDURE	tendon graft	JRF Orthopedics Tendon Graft
OTHER	No intervention	No intervention

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-03-01
• Completion: 2019-09-01
• First posted: 2017-02-23
• Last updated: 2018-01-29

Locations

1 site across 1 country: United States