Acromioclavicular Joint DislocationAC Cons ChirNCT02677441
Conservative or Surgical Management of Rockwood Type III to V Acromioclavicular Dislocations
A study testing Conservative management and Surgery in people with Acromioclavicular Joint Dislocation and Conservative Versus Surgical Management, run by La Tour Hospital at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acromioclavicular Joint Dislocation, Conservative Versus Surgical Management
- What is being tested?
- Conservative management and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2016to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute (less than 10 days) ACJD , with possibility to perform surgery within 10 days after the trauma
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
La Tour Hospital
Meyrin, Canton of Geneva, 1217
Alexandre Lädermann, MD, +41227197555, alexandre.laedermann@gmail.com
About this study
Official title: Conservative or Surgical Management of Rockwood Type III to V Acromioclavicular Dislocations: A Non-inferiority Randomized Study
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:
Read more
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.
Read the detailed description
Background and rationale:
ACJD can be either managed conservatively or surgically. Concerning functional outcomes, it usually accepted that ACJD Rockwood state I and II should be treated conservatively.It is still debated whether grade III should be treated surgically or not, and only experts opinion suggest that grade IV and V has better surgical outcome than conservative. The main literature failed to demonstrate the superiority of the surgical management for functional outcomes. Despite this, operative management results in a better cosmetic outcome, but conservative management is associated with a lower duration of sick leave and lesser costs. It has been purposed by a worldwide expert consensus (ISAKOS consensus) that dynamic posterior clavicle impaction into the trapezius muscle (PICCAT) could be a predictive factor of poor functional outcome in case of conservative management.
Hypothesis:
H0: ASES score at one year of follow-up is better with surgical management than with conservative management.
H1: one year ASES score after conservative management is not inferior as after surgical management. H1 will be first tested without PICCAT. If H1 is validated, it will then be tested again including all patients, PICCAT or not.
Study design:
This multicentric case-control study is randomized 1:1 between conservative and surgical treatment of ACJD. It is a non-inferiority trial that includes 176 patients that suffers from acute ACJD Rockwood grade III-V. Conservative management will consist of a sling for 10 days followed by a standardized physical therapy program, (Cote et al. 2010) and surgical management will consist of coracoclavicular and acromioclavicular fixation and specific rehabilitation. Clinical follow-up will last one year.
Statistical analysis
Non-inferiority statistical analysis will be performed upon appropriate unilateral 95% confidence interval margin (Z = -1.645), with a non-inferiority margin of 6.4, corresponding to ASES minimal clinically important difference. Analysis is planned in case of "intention to treat" method, but, if patients of the conservative management group undergo surgery because they are unsatisfied, ASES score will be measured prior surgery instead of at one year of follow-up. No statistical adjustments on potential confounders are planned.
Sample size calculation:
ASES score minimal clinically important difference has been estimated to 6.4. ASES standard deviation after surgical management of ACJD has been estimated to 9.7. If there is truly no difference between the surgical and conservative treatments, then 80 patients are required to be 90% sure that the lower limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will be above the non-inferiority limit of -6.4. Mazzoca, one of the main authors of ISAKOS consensus (ISAKOS), has reported operating 50% of Rockwood type III-V ACJD. From this, we can strongly suppose that 50% of Rockwood type III-V ACJD presents PICCAT. Considering a 10% of drop-outs, we therefore need 80/(50%)*110% = 176 patients.
- Being tested
- Conservative management, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative managementProcedure or surgery
Specific standardized rehabilitation protocol under Cote et al (2010)
SurgeryProcedure or surgery
Coracoclavicular and acromioclavicular fixation as described ly Lädermann et al (2011), followed by specific standardized rehabilitation protocol under Cote et al (2010).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding ASES score.
Measured: 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
Measured: one year
Secondary outcomes (20)
Coracoclavicular distance
Will be measured by comparing ipsilateral and controlateral X-ray
Measured: one year
Dynamic posterior shaft of the clavicle
Will be measured on the cross-body adduction Basamania/Alexander view
Measured: one year
Coracoclaviclular ligament integrity
Will be assessed on MRI, and scaled with grade 1 (tendinopathy), grade 2 (partial tear), and grade 3 (full tear) injury scale
Measured: one year
Acromioclavicular ligament integrity
Will be assessed on MRI, and scaled with grade 1 (tendinopathy), grade 2 (partial tear), and grade 3 (full tear) injury scale
Measured: one year
Return to sports
Measured: through study completion, an average of 1 year
Work absenteeism
Measured: through study completion, an average of 1 year
Complication rate
Measured: through study completion, an average of 1 year
cosmetic result
will be scaled on a visual analogue scale, from 0 to 10
Measured: one year
patients satisfaction
will be scaled on a visual analogue scale, from 0 to 10
Measured: one year
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding Constant score.
Measured: 3, 6, and 12 months
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD with and without PICCAT, regarding Constant score.
Measured: 3, 6, and 12 months
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding ASES score.
Measured: 3, and 6 months
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD with and without PICCAT, regarding ASES score.
Measured: 3, and 6 months
SANE score
Measured: 3, 6, and 12 months
ACJI score
Measured: 3, 6, and 12 months
pain VAS score
Measured: 3, 6, and 12 months
Range of motion: elevation of the involved shoulder
Measured: 3, 6, and 12 months
Ranges of motion: lateral rotation of the involved shoulder
Measured: 3, 6, and 12 months
Ranges of motion: medial rotation of the involved shoulder
Measured: 3, 6, and 12 months
Impact of predictors of interest on ASES score
Will be performed my multivariable regression analysis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acromioclavicular Joint DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- La Tour Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Shoulder and Elbow Surgeons Expert Group
- Responsible party
- Principal investigator, Adrien Schwitzguebel, La Tour Hospital
- Investigators
- Adrien Schwitzguébel, MD, Principal investigator, La Tour Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677441
- Sponsor's protocol ID
- GE 15-235
- Acronym
- AC Cons Chir
- Status last verified
- Apr 2019
- First submitted
- 2 Feb 2016
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21344264Tamaoki 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.
PubMed 20687087Beitzel 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.
PubMed 24485119Cote 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.
PubMed 20226315Ladermann 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.
PubMed 20888260
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative or Surgical Management of Rockwood Type III to V Acromioclavicular Dislocations: A Non-inferiority Randomized Study
- ClinicalTrials.gov ID
- NCT02677441
- Acronym / sponsor ID
- AC Cons Chir / GE 15-235
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- La Tour HospitalUniversity, hospital or other
- Collaborators
- Swiss Shoulder and Elbow Surgeons Expert Group
- Study start
- Feb 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and rationale:
ACJD can be either managed conservatively or surgically. Concerning functional outcomes, it usually accepted that ACJD Rockwood state I and II should be treated conservatively.It is still debated whether grade III should be treated surgically or not, and only experts opinion suggest that grade IV and V has better surgical outcome than conservative. The main literature failed to demonstrate the superiority of the surgical management for functional outcomes. Despite this, operative management results in a better cosmetic outcome, but conservative management is associated with a lower duration of sick leave and lesser costs. It has been purposed by a worldwide expert consensus (ISAKOS consensus) that dynamic posterior clavicle impaction into the trapezius muscle (PICCAT) could be a predictive factor of poor functional outcome in case of conservative management.
Hypothesis:
H0: ASES score at one year of follow-up is better with surgical management than with conservative management.
H1: one year ASES score after conservative management is not inferior as after surgical management. H1 will be first tested without PICCAT. If H1 is validated, it will then be tested again including all patients, PICCAT or not.
Study design:
This multicentric case-control study is randomized 1:1 between conservative and surgical treatment of ACJD. It is a non-inferiority trial that includes 176 patients that suffers from acute ACJD Rockwood grade III-V. Conservative management will consist of a sling for 10 days followed by a standardized physical therapy program, (Cote et al. 2010) and surgical management will consist of coracoclavicular and acromioclavicular fixation and specific rehabilitation. Clinical follow-up will last one year.
Statistical analysis
Non-inferiority statistical analysis will be performed upon appropriate unilateral 95% confidence interval margin (Z = -1.645), with a non-inferiority margin of 6.4, corresponding to ASES minimal clinically important difference. Analysis is planned in case of "intention to treat" method, but, if patients of the conservative management group undergo surgery because they are unsatisfied, ASES score will be measured prior surgery instead of at one year of follow-up. No statistical adjustments on potential confounders are planned.
Sample size calculation:
ASES score minimal clinically important difference has been estimated to 6.4. ASES standard deviation after surgical management of ACJD has been estimated to 9.7. If there is truly no difference between the surgical and conservative treatments, then 80 patients are required to be 90% sure that the lower limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will be above the non-inferiority limit of -6.4. Mazzoca, one of the main authors of ISAKOS consensus (ISAKOS), has reported operating 50% of Rockwood type III-V ACJD. From this, we can strongly suppose that 50% of Rockwood type III-V ACJD presents PICCAT. Considering a 10% of drop-outs, we therefore need 80/(50%)*110% = 176 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative management | Experimental | Procedure: Conservative managementConservative management includes a sling for 10 days, followed by specific standardized validated rehabilitation that includes range of motion recovery and progressive reinforcement. |
| Surgery | Active comparator | Procedure: SurgerySurgical fixation of ACJD with coracoclavicular and acromioclavicular fixation, followed by specific standardized validated rehabilitation that includes range of motion recovery and progressive reinforcement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- acute (less than 10 days) ACJD , with possibility to perform surgery within 10 days after the trauma
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative managementSpecific standardized rehabilitation protocol under Cote et al (2010) | Procedure or surgery | Conservative management |
| SurgeryCoracoclavicular and acromioclavicular fixation as described ly Lädermann et al (2011), followed by specific standardized rehabilitation protocol under Cote et al (2010). | Procedure or surgery | Surgery |
Primary outcome
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding ASES score.
Time frame: one year
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD with and without PICCAT, regarding ASES score.
Time frame: one year
Will be considered as a secondary outcome if Outcome # 1 is not reached
20 secondary outcomes
Coracoclavicular distance
Time frame: one year
Dynamic posterior shaft of the clavicle
Time frame: one year
Coracoclaviclular ligament integrity
Time frame: one year
Acromioclavicular ligament integrity
Time frame: one year
Return to sports
Time frame: through study completion, an average of 1 year
Work absenteeism
Time frame: through study completion, an average of 1 year
Complication rate
Time frame: through study completion, an average of 1 year
cosmetic result
Time frame: one year
patients satisfaction
Time frame: one year
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding Constant score.
Time frame: 3, 6, and 12 months
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD with and without PICCAT, regarding Constant score.
Time frame: 3, 6, and 12 months
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding ASES score.
Time frame: 3, and 6 months
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD with and without PICCAT, regarding ASES score.
Time frame: 3, and 6 months
SANE score
Time frame: 3, 6, and 12 months
ACJI score
Time frame: 3, 6, and 12 months
pain VAS score
Time frame: 3, 6, and 12 months
Range of motion: elevation of the involved shoulder
Time frame: 3, 6, and 12 months
Ranges of motion: lateral rotation of the involved shoulder
Time frame: 3, 6, and 12 months
Ranges of motion: medial rotation of the involved shoulder
Time frame: 3, 6, and 12 months
Impact of predictors of interest on ASES score
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Background: PubMed 21344264Smith 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.
- Background: PubMed 20687087Tamaoki 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.
- Background: PubMed 24485119Beitzel 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.
- Background: PubMed 20226315Cote 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.
- Background: PubMed 20888260Ladermann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrien Schwitzguébel, MD principal investigator
La Tour Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative management and Surgery in people with Acromioclavicular Joint Dislocation and Conservative Versus Surgical Management, run by La Tour Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Lädermann, PD (+41227197555, secretariat.laedermann@latour.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding ASES score. (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02677441, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.