|- candidate number||13192|
|- NTR Number||NTR3554|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-aug-2012|
|- Secondary IDs||NL41658.100.12 CCMO|
|- Public Title||‘Abduction brace versus sling after arthroscopic cuff repair‘.|
|- Scientific Title||‘Abduction brace versus sling after arthroscopic cuff repair‘.|
|- hypothesis||Our hypothesize is that by using an abduction brace after arthroscopic rotator cuff repair, postoperative pain can be reduced compared with using a standard sling to immobilize te arm.|
|- Healt Condition(s) or Problem(s) studied||Cuff lesion|
|- Inclusion criteria||1. Cuff repair (primary procedure) for confirmed cuff lesion;|
2. Subacromial decompression (optional secondary procedure);
3. Sufficient understanding of the Dutch language;
4. Competent adults;
5. Willing and able to comply to the study protocol.
|- Exclusion criteria||1. Age <18, >75;|
2. BMI >35;
3. Diabetes mellitus;
4. Chronic pain diseases, fibromyalgia;
5. Current treatment with opiates;
6. Immunocompromized/ HIV+;
7. Labral repair;
8. Lateral clavicle resection;
9. Secondary suturing;
10. Psychiatric patients.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2012|
|- planned closingdate||1-mrt-2013|
|- Target number of participants||40|
|- Interventions||We will study the effect on pain in patients undergoing arthroscopic cuff repair comparing an abduction brace with a sling.
Group 1: Sling
The slings hold the elbow at 90 degrees, and restricts exorotation.
Group 2: Abduction brace
The brace holds the arm in 45 degrees of abduction and in neutral rotation.
Before surgery, the patient is randomized into one of the two groups, by the researcher.
The allocated group will be noted in the patient file and the orthopaedic surgeon will be informed. Surgery will be performed with the patient in the beach-chair position and under general anesthesia and a interscalene block. The surgery will be fully arthroscopic, and a double row suture bride technique will be used.
When the surgery is finished, before transferring the patient the brace of sling will be put on.
Directly after surgery, pain scores are determined at the PACU and ward. The patient is asked to keep a diary of the pain score at home on daily or weekly base in a diary.
The rehabilitation program for both groups is equal and will be communicated to their own physiotherapist by letter. The first 6 weeks they have to wear the sling or brace day and night and are advised to perform circumduction exercises at home. The physiotherapist will perform passive motions exercises to maximum 70 degrees of elevation and 20 degrees of exorotation. No active motion is allowed for six weeks or until complete recovery of passive motion had occurred. After six weeks, active motions exercises guided by the physiotherapist are allowed.
|- Primary outcome||The main parameter of this study will be the difference in pain between the patients receiving an abduction brace and patients receiving a sling. This will be measured once preoperatively, eight times in the first 48 hours postoperatively, twice a day in the remaining first week and then weekly up to three months. The participants will fill in the VAS score on a 10 cm wide horizontal scale. |
|- Secondary outcome||Secondary parameters are the Constant, ASES (only ROM part), WORC and EQ-5D score. Intra-operatively the orthopaedic surgeon will classify the size of the cuff tear according to the classification systems described by Thomazeau (stage 1-5) and by Boileau (A-F). |
|- Timepoints||1. Pre-op;|
2. Post-op: Day 1; Day 2-7; week 3; Week 6 Week 12.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Nienke Wolterbeek|
|- CONTACT for SCIENTIFIC QUERIES|| Nienke Wolterbeek|
|- Sponsor/Initiator ||St Antonius hospital|
(Source(s) of Monetary or Material Support)
|St Antonius Hospital, Nieuwegein|
|- Brief summary||Patients undergoing shoulder arthroscopy often complain of postoperative shoulder pain. There might be a correlation with the postoperative arm positioning and the pain experienced in the first postoperative weeks. In this study we compare an abduction brace with the currently used sling. Using this abduction brace, there will be less tension on the rotator cuff thereby reducing pain.|
|- Main changes (audit trail)|
|- RECORD||1-aug-2012 - 19-dec-2012|