Research proposalTo find out what is the best surgical procedure for patients with conservative therapy resistent calcifying tendinitis of the shoulder. Objectives Our main objective is to compare the three different surgical procedures for the…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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)
Background summary
Calcifying tendinitis of the shoulder is a common disease in which calcium
particles are deposited in one or more tendons of the rotator cuff muscles
(Figure 1). This results in a typical pattern of pain, impairments in daily
living and decreased range of motion. In a population without shoulder
complaints the incidence of subacromial calcific deposits is about 3- 20%. When
considering patients with shoulder complaints the incidence rises to 7- 54%.
The disease mainly affects individuals between 30 and 60 years of age. Males
and females are equally
affected.1-3 The calcific material consists of a collection of calcium
hydroxyapatite in crystalline or amorphous form. About 80% of the calcium
deposits are located in the tendon of the supraspinatus, 15% are in the
infraspinatus- and about 5% are in the subscapular tendon. In the supraspinatus
tendon the most affected location is at 1.5 to 2.0 cm of its insertion at the
major tuberculum of the humeral bone.2, 4, 5, 8
The aetiology of calcifying tendinitis of the rotator cuff muscles is still a
matter of dispute. It has been suggested that it is related to decreased local
oxygen tension or hypoxia.2
The disease is at first treated conservatively, including anti-inflammatory
drugs, ice-therapy, physiotherapy, corticosteroid injections, extracorporeal
shock wave therapy and/or needling. This often shows good clinical results and
in some cases the disease is self-limiting. 2, 10, 11
However, when this fails the next step treatment is often surgery. If surgery
is chosen as a therapy there is not a consensus about which surgical procedure
should be carried out. 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 (Figure 2).
The last procedure is to solely debride the calcifications without an
acromioplasty.
Study objective
Research proposal
To find out what is the best surgical procedure for patients with conservative
therapy resistent calcifying tendinitis of the shoulder.
Objectives
Our main objective is to compare the three different surgical procedures for
the treatment of calcifying tendinitis of the shoulder and to determine if one
surgical treatment should be preferred, both in the short term (6 weeks, ± 1
week) and in the mid term (6 months, ± 2 weeks).
Hypothesis
Our hypothesis is that all three surgical treatments 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 mid term (6 months, ± 2
weeks).
Study design
Prospective, multicentre, randomised, single blind, controlled trial. The
additional centres will be contacted after METC approval.
Intervention
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 attached coraco-acromial ligament
in combination with a bursectomy). The second procedure we will include the
same acromioplasty but in combination with the debridement of the
calcifications. This debridement will be done by localizing the calcifications
by needling during shoulder arthroscopy (often an increased vascularisation
around the calcifications), when the calcification is localized it will be
debrided using a shaver and extensive rinsing (Figure 2).
The last procedure is solely debride the calcifications without a Neer
acromioplasty.
Study burden and risks
Nature and extent of the burden and risks associated with participation
All patients will receive standard preoperative care, including all above
mentioned conservative therapies. Possible risks are those associated with the
surgical procedure. All surgical procedures are part of the standard care in
many medical institutes.(bron 4, 5) As far as we know the risks are equal in
our whole study population. All patients will receive the standard
rehabilitation protocol after surgery of the shoulder (appendix 1).
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50468.096.14 |