The objective is to evaluate and compare the outcome of conventional open or arthroscopic rotator cuff surgery, by means of clinical scores and biomechanical studies (range of motion, scapulohumeral rhythm, muscle activation patterns).
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disabilities of Arm, Shoulder and Hand Score (DASH) at different follow up
visits (pre-op; 6 wk; 3 mth; 6 mth; 12 mth; 24 mth).
Addendum:
Standardized RoM*s before and after surgery
Secondary outcome
Visual Analogue Scale for pain (VAS pain), Simple Shoulder Test (SST),
Constant Murley score and clinical shoulder function 12 months post
operativally. Evauation of cuff quality by MR-arthrography 12 months post
operativally.
Addendum:
EMG shoulder muscle activation patterns during standardized tasks -->
Activation ratio
Background summary
Rotator cuff ruptures are one of the most prevalent medical conditions
concerning the musculoskeletal system with considerable morbidity. Operative
intervention in indicated when conservative treatment fails. This can be done
by the conventional open repair surgery of by an arthroscopic procedure. The
latter being a up and coming procedure with a lot of revolutionairy
developments in the last decade. The major advantage is its minimally invasive
character. A study on open versus arthroscopic shoulder stabilisation surgeries
showed an increase in cost effectiveness in favour of arthroscopy. A
disadvantage is an extended learing curve. Furthermore there is speculation on
the quality of the repair and the complication rate. At this point it is not
clear wether there is a difference with regard to pain and function after
conventional open or arthroscopic rotator cuff surgery.
Pathologic muscle activation patterns have been reported in patients with
rotator cuff ruptures: activation of ADductors during ABduction in order to
generate an increase in subacromial volume. It is unknown whether rotator cuff
repair leads to normalization of this pathologic muscle activation patterns.
Additionally, it is unknown whether rotator cuff repair is a useful procedure
from a biomechanical viewpoint. Therefore, we will include the last 40 patients
of the NRC-study for this addendum: a biomechanical study.
Study objective
The objective is to evaluate and compare the outcome of conventional open or
arthroscopic rotator cuff surgery, by means of clinical scores and
biomechanical studies (range of motion, scapulohumeral rhythm, muscle
activation patterns).
Study design
A prospective randomised clinical trial in which the outcomes of conventional
open or arthroscopic rotator cuff surgery performed by 1 orthopaedic surgeon
are being compared. Flow chart on page 11 of the protocol.
Intervention
Conventional open and arthroscopic rotator cuff surgery.
Study burden and risks
No additional risk or increased complication rate, because both surgical
procedures are standardised treatments in the orthopaedic practise.
Addendum:
2 visits at the LUMC for biomechanical studies (74 minutes). No additional
risks.
St. Antonius Ziekenhuis Nieuwegein. Tav dr. H. van der Hoeven, orthopaedisch chirurg, secretaris NVA
Postbus 2500 3530 EM Nieuwegein
NL
St. Antonius Ziekenhuis Nieuwegein. Tav dr. H. van der Hoeven, orthopaedisch chirurg, secretaris NVA
Postbus 2500 3530 EM Nieuwegein
NL
Listed location countries
Age
Inclusion criteria
* Full thickness cuff rupture proven on MR-arthrography
* Signed Informed Consent form
Exclusion criteria
* age < 18 year; > 75 year
* neurologic etiology
* glenohumeral instability
* traumatic shoulder/old fracture
* frozen shoulder
* reumatoïd arthritis
* history of shoulder infection
* history of (attempt) cuff repair
* history of wound healing problems (dehiscence, infections e.g.)
* acromionresection
* cuff arthropathy
* perioperativally not able to close defect or partial thickness rupture
* non compliance with regard to follow up
* not capable of speaking and writting dutch language
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL19378.098.07 |