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…
ID
Bron
Verkorte titel
Aandoening
Our study population will include patients with chronic (>6 months) shoulder complaints with calcifications visible on conventional x-rays and not responded to conservative therapy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
6.2.1 VAS for pain<br>
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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).
Onderzoeksopzet
•Start T=0 (>6 months of conservative treatment)
•6 weeks post-operatively
•6 months post-operatively
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
Wetenschappers
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
•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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
•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
Opzet
Deelname
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In overige registers
Register | ID |
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NTR-new | NL4947 |
NTR-old | NTR5051 |
Ander register | NL50468.096.14, CCMO : 14-T-112, METC |