Recruiting

Coracoclavicular Reconstruction

Sponsor:

Dr. Brian Lee

Code:

NCT03060564

Conditions

Acromioclavicular Joint Dislocation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

tendon graft

No intervention

Study Details

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.

Conditions

Acromioclavicular Joint Dislocation

Study ID

NCT03060564

Start date

Mar 1, 2017

Status verified date

Jan, 2018

Completion date

Sep, 2019

Anticipated

Primary completion date

Mar, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: AC repair with tendon graft

acromioclavicular repair with tendon graft.

active comparator: AC repair with no tendon graft

acromioclavicular repair without tendon graft/no intervention

Interventions

tendon graft

JRF Orthopedics Tendon Graft

No intervention

No intervention

Primary outcome measure

  • Complication Rates with and without the use of graft tendons [ Time Frame: 2 years ]
  • (American Shoulder Elbow Society (ASES) [ Time Frame: 2 years ]
  • Instability Index Constant Score (ISIS) [ Time Frame: 2 years ]
  • Simple Shoulder Test (SST) [ Time Frame: 2 years ]
  • Short Form-12 [ Time Frame: 2 years ]
  • Single Assessment Numerical Evaluation (SANE) [ Time Frame: 2 years ]
  • Visual Analog Score (VAS) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Study Coordinator

3104233198Christopher.Klein@cshs.org

Locations

Cedars-Sinai Kerlan-Jobe Institute at White Memorial Hospital

Recruiting

Los Angeles, California, United States, 90033

Contacts

Chris Kelin

310-423-3198

More Information

Sponsor

Dr. Brian Lee

Last update posted

Jan 29, 2018

Last verified

Jan, 2018

Keywords

  • shoulder
  • orthopaedics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Brian Lee on 2018-01-29.