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Calcifying tendinitis of the shoulder: What is the best surgical treatment?

Calcifying tendinitis of the shoulder: What is the best surgical treatment? - Surgical treatment of calcifying tendinitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40852
Enrollment
90
Registered
2014-12-16
Start date
2015-06-23
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

calcific deposits in the rotator cuff tendons subacromial calcific tendonitis

Interventions

The first operative treatment is to perform an acromioplasty according to Neer (including the removal of the anterior edge and under surface of the anterolateral part of the acromion with the attach

Sponsors

Orbis Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age: 30-60 years Full range of motion of the affected shoulder (>120o abduction and anteflexion, unrestricted external rotation) Calcifications on the x-rays Type I en II calcifications according to the Gärtner classification (chapter 4.1.3) Minimal 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 radiological signs of full-thickness lesion of, one of, the rotator cuff tendons. Clinical and radiological signs of acromioclavicular osteoarthritis History of rheumatic arthritis or fibromyalgia Type III calcifications according to the Gärtner classification (chapter 4.1.3) Not able or willing to participate in this trial

Design outcomes

Primary

MeasureTime frame
Primary outcome (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

MeasureTime frame
Questionnaires Functional outcome and impairment in daily living as determined by answers to patient outcomes questionnaires: Constant Murley Score, DASH and ASES: • Functional outcome will be measured using the 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. • Patient Reported Outcome Measurements (PROMS); these are scores which are able to assess the impairments of patients in daily living. In the ASES score 1 is the worst score and 100 the best score in which has an optimal functioning shoulder. In the DASH score 1 is no disabilities in daily living and 100 the worst impairments in daily living. 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 x-ray with the arm external rotation). Internal rotation is to visualise the calcification, and external rotation is to be able to measure the acromio-humeral interval. (protocol, chapter 5 en bron12)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)