Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cedars-Sinai Medical Center | OTHER |
| Kerlan-Jobe Institute | UNKNOWN |
| White Memorial Hospital | UNKNOWN |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC repair with tendon graft | Experimental | acromioclavicular repair with tendon graft. |
|
| AC repair with no tendon graft | Active Comparator | acromioclavicular repair without tendon graft/no intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tendon graft | Procedure | JRF Orthopedics Tendon Graft |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rates with and without the use of graft tendons | loss of radiographic reduction, infection, need for more surgery | 2 years |
| (American Shoulder Elbow Society (ASES) | Shoulder Function survey (17 multiple choice questions). | 2 years |
| Instability Index Constant Score (ISIS) | Shoulder Instability survey for last 4 weeks (yes/no and multiple choice). Score is graded poor, fair, good, excellent. | 2 years |
| Simple Shoulder Test (SST) | Shoulder Function survey (12 yes/no questions) | 2 years |
| Short Form-12 | This survey assesses patient's health satisfaction. This information will help keep track of how patients feel and how well patients are able to do your usual activities. (12 multiple choice questions) | 2 years |
| Single Assessment Numerical Evaluation (SANE) | Patient assessment rating from 0-100 shoulder normality | 2 years |
| Visual Analog Score (VAS) | Measurement of shoulder pain from 0 (no pain) to 10 (unbearable distress) | 2 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 3104233198 | Christopher.Klein@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Brian Lee, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Kerlan-Jobe Institute at White Memorial Hospital | Recruiting | Los Angeles | California | 90033 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| No intervention |
| Other |
No intervention |
|