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Status unknownNCT03060564Updated Jan 29, 2018

Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft

An interventional study of tendon graft and No intervention in Acromioclavicular Joint Dislocation, sponsored by Dr. Brian Lee. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-29.

Sponsored by Dr. Brian Lee · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Acromioclavicular Joint Dislocation

Keywords

  • shoulder
  • orthopaedics
03

In context

Lead sponsor

This is the only study on the registry with Dr. Brian Lee as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Displaced acromioclavicular joint dislocation sustained within 3 weeks of surgery
  • recommended for operative fixation
  • age 18 years or older

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    AC repair with tendon graft

    acromioclavicular repair with tendon graft.

    Procedure: tendon graft

  • Active comparator
    AC repair with no tendon graft

    acromioclavicular repair without tendon graft/no intervention

    Other: No intervention

Interventions

  • Proceduretendon graft

    JRF Orthopedics Tendon Graft

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. Complication Rates with and without the use of graft tendons

    loss of radiographic reduction, infection, need for more surgery

    Time frame: 2 years

  2. (American Shoulder Elbow Society (ASES)

    Shoulder Function survey (17 multiple choice questions).

    Time frame: 2 years

  3. Instability Index Constant Score (ISIS)

    Shoulder Instability survey for last 4 weeks (yes/no and multiple choice). Score is graded poor, fair, good, excellent.

    Time frame: 2 years

  4. Simple Shoulder Test (SST)

    Shoulder Function survey (12 yes/no questions)

    Time frame: 2 years

  5. 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)

    Time frame: 2 years

  6. Single Assessment Numerical Evaluation (SANE)

    Patient assessment rating from 0-100 shoulder normality

    Time frame: 2 years

  7. Visual Analog Score (VAS)

    Measurement of shoulder pain from 0 (no pain) to 10 (unbearable distress)

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Cedars-Sinai Kerlan-Jobe Institute at White Memorial Hospital
    Los Angeles, California 90033, United States
    Recruiting
    • Chris Kelin · Contact310-423-3198
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2017 (actual). Primary completion is estimated for Mar 2019, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2017
First posted
Feb 23, 2017
StartActual
Mar 1, 2017
Primary completionEst.
Mar 2019
CompletionEst.
Sep 2019
Last update
Jan 29, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03060564
Lead sponsor
Dr. Brian Lee
Collaborators
Cedars-Sinai Medical Center, Kerlan-Jobe Institute, White Memorial Hospital
Responsible party
Dr. Brian Lee (orthopedic surgeon specializing in arthroscopic and open surgery of all conditions of the shoulder and elbow including arthritis, tendon disorders, fractures, and instability, Cedars-Sinai Medical Center) — Sponsor-investigator
First posted
Feb 23, 2017
Start date
Mar 1, 2017
Primary completion
Mar 2019 (estimated)
Completion
Sep 2019 (estimated)
Last update
Jan 29, 2018

Study contacts

Study Coordinator
Contact
Christopher.Klein@cshs.org
3104233198
Brian Lee, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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