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‘Abduction brace versus sling after arthroscopic cuff repair‘.

‘Abduction brace versus sling after arthroscopic cuff repair‘.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22650
Enrollment
40
Registered
2012-08-01
Start date
2012-10-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

cuff lesion

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 exor

Sponsors

St. Antonius Ziekenhuis Postbus 2500 3430 EM Nieuwegein The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Age 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Contacts

Public ContactNienke Wolterbeek

Afdeling Orthopedie St. Antonius Ziekenhuis Postbus 2500

orthopedie-research@antoniusziekenhuis.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)