|- candidate number||21604|
|- NTR Number||NTR5051|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-jan-2015|
|- Secondary IDs||14-T-112, METC NL50468.096.14, CCMO|
|- Public Title||Verkalkende tendinitis van de schouder:
Is er een te prefereren chirurgische behandeling?|
|- Scientific Title||Calcifying tendinitis of the shoulder:
Is there a preferrable surgical treatment?
A Prospective, Multicentre, Randomized, Clinical, Single blind study|
|- ACRONYM||calcifying, tendinitis, surgical treatment, randomized controlled trial|
|- hypothesis||Our hypothesis is that all three surgical treatments (Arthroscopic Neer, Arthroscopic debridement of calcifications or Arthroscopic Neer + debridement of calcifications) will lead to a significant pain reduction and all three surgical procedures shows to the same reduction, both in the short term (6 weeks, ± 1 week) and in the midterm (6 months, ± 2 weeks). |
|- Healt Condition(s) or Problem(s) studied||Shoulder pain, Chronic, Calcific tendonitis, Non-responders|
|- Inclusion criteria||•Age: 30-60 years|
•Full range of motion of the affected shoulder (>120o abduction and anteflexion, unrestricted external rotation of >80o)
•Calcifications on the x-rays
o Type I and II calcifications according to the Gärtner classification (chapter 4.1.3)
oMinimal diameter of 5 mm on AP view
•Unsuccessful conservative therapy for at least 6 months
•Ability and willingness to fill out the necessary questionnaires
|- Exclusion criteria||•Clinical signs of a frozen shoulder or adhesive capsulitis|
•Operations of the affected shoulder in personal medical history
•Clinical and radiologic signs of full-thickness lesion of, one of, the rotator cuff tendons.
•Clinical and radiologic signs of acromioclavicular osteoarthritis
•History of rheumatic arthritis or fibromyalgia
•Type III calcifications according to the Gärtner classification
•Not able or willing to participate in this trial
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2015|
|- planned closingdate||1-nov-2016|
|- Target number of participants||114|
|- Interventions||There are three main surgical procedures of calcifying tendinitis of the shoulder. The first one is to perform an acromioplasty according to Neer (including the removal of the anterior edge and undersurface of the anterior part of the acromion with the attached coraco-acromial ligament in combination with a bursectomy). The second procedure is the same acromioplasty but then in combination with debridement of the calcifications. This debridement will be done by localizing the calcifications by needling during shoulder arthroscopy, when the calcification is localized it will be debrided using a shaver and extensive rinsing. The last procedure is to solely debride the calcifications without an acromioplasty. |
|- Primary outcome||6.2.1 VAS for pain|
This pain score indicates on a scale from 1 till 100 their pain level. In this scale 1 is minor pain and 100 is the worst pain they ever experienced.
|- Secondary outcome||Questionnaires|
Impairment in daily living as determined by answers to patient outcomes questionnaires: DASH and ASES.
•ASES score 1 is the worst score and 100 the best score in which has an optimal functioning shoulder.
•DASH score 1 is no disabilities in daily living and 100 the worst impairments in daily living.
The functional outcome will be assessed by measuring the schoulder functional accoording to the Constant Murley Score.
•Constant Murley Score, this is score in which patients and medical assessors report the functional outcome. In this score 1 is the worst score and 100 the best score in which has an optimal functioning shoulder.
In order to measure the radiological outcome conventional X-rays of the shoulder are made at all consultation moments. The X-rays are taken in three views (clear AP view, AP view with the upper arm in internal and one with the arm in external rotation). Internal rotation is to visualise the calcification and to be able to measure any changes in the size and Gärtner’s classification of the calcifications, and external rotation is to measure the acromio-humeral interval to be able to tell whether the Neer acromioplasty was done adequately.
|- Timepoints||•Start T=0 (>6 months of conservative treatment)|
•6 weeks post-operatively
•6 months post-operatively
|- Trial web site||NA|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. M.G.M. Schotanus|
|- CONTACT for SCIENTIFIC QUERIES||Drs. M.G.M. Schotanus|
|- Sponsor/Initiator ||Dr. E.J.P Jansen|
(Source(s) of Monetary or Material Support)
|- Brief summary||Calcifying tendinitis of the shoulder is a common disorder and has a large disease burden. The disease is first treated conservatively, including anti-inflammatory drugs, ice-therapy, physiotherapy, corticosteroid injections, extracorporeal shock wave therapy (ESWT) and/or needling. After a failed conservative treatment, surgery is often the next step treatment. However, there is no consensus about whether there is an preferred surgical procedure. Several studies have investigated different surgical procedures separately, but there are not any comparing studies available in current literature, especially no Randomized Controlled Trial (RCT). There are three main surgical procedures to treat calcifying tendinitis of the shoulder: The first one is to perform an acromioplasty according to Neer (including the removal of the anterior edge and undersurface of the anterior part of the acromion with the attached coraco-acromial ligament in combination with a bursectomy); The second procedure is the same acromioplasty but in combination with debridement of the calcification; The last procedure is to solely debride the calcifications without an acromioplasty. |
|- Main changes (audit trail)|
|- RECORD||22-jan-2015 - 18-apr-2015|