Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft

Dr. Brian Lee

Status: Unknown

Conditions: Acromioclavicular Joint Dislocation

Treatments: Other: No intervention; Procedure: tendon graft

Study type: Interventional

Funder types: Other

Identifiers

NCT03060564

Pro46696

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

AC repair with tendon graft

Experimental group

Description:

acromioclavicular repair with tendon graft.

Treatment:

Procedure: tendon graft

AC repair with no tendon graft

Active Comparator group

Description:

acromioclavicular repair without tendon graft/no intervention

Treatment:

Other: No intervention