Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/31/2018 |
| Start Date: | March 1, 2017 |
| End Date: | September 2019 |
| Contact: | Study Coordinator |
| Email: | Christopher.Klein@cshs.org |
| Phone: | 3104233198 |
A Randomized, Prospective Trial Comparing Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft
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.
coracoclavicular (CC) joint reconstruction with and without the use of tendon graft as an
augmentation to repair.
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.
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.
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.
We found this trial at
1
site
Los Angeles, California 90033
Phone: 310-423-3198
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