Open Versus Arthroscopic Assisted Treatment of Acute Acromioclavicular Joint Disruption Using Suture Button Device

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-60
SponsorAssiut University

About this trial

Compare the clinical and radiological outcome between the arthroscopic and open surgical repair using suture button device method in cases with acute AC joint disruption

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age of 16 to 60 years

Definite radiographic diagnosis of isolated Rockwood type IIIb(unstable), IV and type v acromioclavicular joint dislocation

Time from injury to operation < 3 weeks

Patient with complete at least 12-month follow-up assessments

Disqualifiers

. Age outside the range

Open injury, old injury (≥ 3 weeks since injury)

Injury caused by other diseases (tendinitis, metabolic, et al.), concurrent shoulder osteoarthritis, arthropathy or any fracture

Any previous operation of the injured limb

Trial population

Patients meeting the inclusion criteria and willing to take part in the study will be included investigators conducted an a priori test for sample size calculation using the G\*Power 3.1.9.2 software. investigators assumed a CMS mean difference between the 2 groups of 16 points, a standard deviation of 20 points, an alpha of 0.05, and power (1 - b) of 80%; 21 subjects had to be included in each group. Our goal was to include 27 cases in each group to compensate for any lost subjects during the follow-up phase

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

54 Participants
are grouped into 2 trial groups
Group A: group 1
Group B: group 2

Trial outcomes

Primary outcomes

1

Radiological evaluation using the true anteroposterior view of the shoulder

Radiological evaluation using the true anteroposterior view of the shoulder and AC projection (10 cephalic tilt with the beam centered over the AC joint)

Time frame
preoperative, three month postoperative and six month postoperative

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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