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Verkalkende tendinitis van de schouder: Is er een te prefereren chirurgische behandeling?

Calcifying tendinitis of the shoulder: Is there a preferrable surgical treatment? A Prospective, Multicentre, Randomized, Clinical, Single blind study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24524
Enrollment
114
Registered
2015-01-22
Start date
2015-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 unders

Sponsors

Dr. E.J.P Jansen, investigator initiated, with a financial sponsor
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
6.2.1VAS 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

MeasureTime frame
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. Functional outcome 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. Radiological outcome 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.

Contacts

Public ContactM.G.M. Schotanus

Department of Orthopedic Surgery, Orbis Medisch Centrum dr H vd Hoffplein 1

m.schotanus@orbisconcern.nl+31 (0)88 4597823

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)