MedTrace Logo

Conservative or Surgical Management of Rockwood Type III to V Acromioclavicular Dislocations

NCT02677441 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2019-04-12

No results posted yet for this study

Summary

This study will evaluate the non-inferiority of conservative management for acromioclavicular clavicle disjunction, compared with surgical management. Half of patients will be treated with a specific standardized rehabilitation protocol, and the other half will be treated with coracoclavicular and acromioclavicular fixation, followed by a another specific standardized rehabilitation protocol.

Outcomes:

The primary outcome is the non-inferiority of the conservative management over surgical management of Rockwood III-V Acute acromioclavicular joint dislocation (ACJD) without PICCAT with American Shoulder and Elbow Surgeons (ASES score) at one year. If the non-inferiority is reached, the non-inferiority of the conservative management over surgical the management of Rockwood III-V ACJD with PICCAT using ASES score at one year will be evaluated.

Secondary outcomes were radiological criteria (i.e. comparison of ipsilateral and contralateral coracoclavicular distance on anterior view; and dynamic posterior shaft of the cross-body adduction Basamania/Alexander view) return to sports, work absenteeism, complication rate, cosmetic results, patients satisfaction, Constant score, Single Assesment Numeric Evaluation (SANE) score, Acromioclavicular Joint Instability (ACJI) score, ASES score at others timepoints, and range of motion of the implicated shoulder. Finally, multivariable regression analysis will be performed in order to evaluate the impact of predictors of interest on ASES score at one year.

Conditions

  • Acromioclavicular Joint Dislocation
  • Conservative Versus Surgical Management

Interventions

PROCEDURE

Conservative management

Specific standardized rehabilitation protocol under Cote et al (2010)

PROCEDURE

Surgery

Coracoclavicular and acromioclavicular fixation as described ly Lädermann et al (2011), followed by specific standardized rehabilitation protocol under Cote et al (2010).

Sponsors & Collaborators

  • Swiss Shoulder and Elbow Surgeons Expert Group

    collaborator UNKNOWN

  • La Tour Hospital

    lead OTHER

Principal Investigators

  • Adrien Schwitzguébel, MD · La Tour Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02677441 on ClinicalTrials.gov