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

NCT02677441 | Unknown DMC

• 1 other identifier: GE 15-235
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding ASES score.

  one year

• The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD with and without PICCAT, regarding ASES score.

  Will be considered as a secondary outcome if Outcome # 1 is not reached

  one year

Secondary Outcomes (20)

• Coracoclavicular distance

  one year

• Dynamic posterior shaft of the clavicle

  one year

• Coracoclaviclular ligament integrity

  one year

• Acromioclavicular ligament integrity

  one year

• Return to sports

  through study completion, an average of 1 year

Study Arms (2)

Conservative management

EXPERIMENTAL

Conservative management includes a sling for 10 days, followed by specific standardized validated rehabilitation that includes range of motion recovery and progressive reinforcement.

Procedure: Conservative management

Surgery

ACTIVE COMPARATOR

Surgical fixation of ACJD with coracoclavicular and acromioclavicular fixation, followed by specific standardized validated rehabilitation that includes range of motion recovery and progressive reinforcement.

Procedure: Surgery

Interventions

Conservative management PROCEDURE

Specific standardized rehabilitation protocol under Cote et al (2010)

Conservative management

Surgery PROCEDURE

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

Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute (less than 10 days) ACJD , with possibility to perform surgery within 10 days after the trauma

You may not qualify if:

• Rockwood grade I, II, or IV ACJD
• Significant other trauma of the involved upper member requiring surgery
• Associated scapula or clavicle fracture
• Polytrauma inducing significant limitation of rehabilitation process
• Inability to follow properly conservative management or post-surgery recommendations
• Patients suffering from symptomatic anaemia, or patients with severe cardiorespiratory insufficiency
• Known or suspected non-compliance, drug or alcohol abuse
• Patients incapable of judgement or under tutelage
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• Enrolment of the investigator, his/her family members, employees and other dependent persons

Sponsors & Collaborators

• La Tour Hospital: lead
• Swiss Shoulder and Elbow Surgeons Expert Group: collaborator

Study Sites (1)

La Tour Hospital

Meyrin, Canton of Geneva, 1217, Switzerland

RECRUITING

Related Publications (5)

• Smith TO, Chester R, Pearse EO, Hing CB. Operative versus non-operative management following Rockwood grade III acromioclavicular separation: a meta-analysis of the current evidence base. J Orthop Traumatol. 2011 Mar;12(1):19-27. doi: 10.1007/s10195-011-0127-1. Epub 2011 Feb 23.

  PMID: 21344264 BACKGROUND

• Tamaoki MJ, Belloti JC, Lenza M, Matsumoto MH, Gomes Dos Santos JB, Faloppa F. Surgical versus conservative interventions for treating acromioclavicular dislocation of the shoulder in adults. Cochrane Database Syst Rev. 2010 Aug 4;2010(8):CD007429. doi: 10.1002/14651858.CD007429.pub2.

  PMID: 20687087 BACKGROUND

• Beitzel K, Mazzocca AD, Bak K, Itoi E, Kibler WB, Mirzayan R, Imhoff AB, Calvo E, Arce G, Shea K; Upper Extremity Committee of ISAKOS. ISAKOS upper extremity committee consensus statement on the need for diversification of the Rockwood classification for acromioclavicular joint injuries. Arthroscopy. 2014 Feb;30(2):271-8. doi: 10.1016/j.arthro.2013.11.005.

  PMID: 24485119 BACKGROUND

• Cote MP, Wojcik KE, Gomlinski G, Mazzocca AD. Rehabilitation of acromioclavicular joint separations: operative and nonoperative considerations. Clin Sports Med. 2010 Apr;29(2):213-28, vii. doi: 10.1016/j.csm.2009.12.002.

  PMID: 20226315 BACKGROUND

• Ladermann A, Grosclaude M, Lubbeke A, Christofilopoulos P, Stern R, Rod T, Hoffmeyer P. Acromioclavicular and coracoclavicular cerclage reconstruction for acute acromioclavicular joint dislocations. J Shoulder Elbow Surg. 2011 Apr;20(3):401-8. doi: 10.1016/j.jse.2010.08.007.

  PMID: 20888260 BACKGROUND

MeSH Terms

Interventions

Conservative Treatment; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Adrien Schwitzguébel, MD

  La Tour Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Lädermann, PD

CONTACT

+41227197555; secretariat.laedermann@latour.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 9, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

CH (1)