The Short Musculoskeletal Function Assessment (SMFA) questionnaire.
Nerys Williams
https://pubmed.ncbi.nlm.nih.gov/27994082/Actively Recruiting
Led by Region Skane · Updated on 2025-06-25
200
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are investigating treatments for stable but displaced fractures of the elbow tip olecranon, specifically Mayo type 2a and 2b fractures. The study compares two surgical methods tension band wiring TBW, which uses pins and metal wire, and cerclage fixation CF, which uses metal wire alone. Previous studies suggest CF may result in fewer re-operations and complications than TBW, so this trial aims to test that hypothesis in a randomized controlled setting. Participants will be randomly assigned to receive either cerclage fixation or tension band wiring surgery. Both procedures involve surgical open reduction and internal fixation of the fracture, with cerclage using two 1.0mm wires and TBW using a 1.0mm wire plus two 1.6mm k-wires. The study will follow 200 patients for 36 months after surgery, with follow-up visits at 2 weeks, 6 weeks, 3 months, 12 months, and 36 months. These visits include physiotherapist assessments and a radiograph at 6 months. During the study, researchers will monitor re-operation rates, complications, patient-reported outcomes using tools like Quick-DASH and SMFA scores, pain levels, elbow motion range, grip strength, and time to return to work. Physiotherapists conducting assessments will not know which surgery was performed. Operation details such as surgery time and radiation exposure will also be recorded. This comprehensive follow-up aims to provide clear results on the benefits and risks of each surgical method.
CONDITIONS
The With Or Without Olecranon K-wires Trial
D
Daniel Wenger, MD, PhD
G
Gustav Cornefjord, MD
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Region Skane
Lead Sponsor
Lund University
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - Up to 14 days before surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and consent
Duration - Surgery day and immediate recovery
Participants undergo surgery to fix the olecranon fracture using either cerclage fixation or tension band wiring.
1 surgical procedure (in-person)
Duration - Up to 36 months after surgery
Participants attend follow-up visits with a physiotherapist to assess recovery, complications, pain, arm function, and satisfaction after surgery.
Visits at 2 weeks, 6 weeks, 3 months, 6 months (radiograph), 12 months, and 36 months
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Nerys Williams
https://pubmed.ncbi.nlm.nih.gov/27994082/Sari Ponzer, Anne Skoog, Gunnar Bergström
https://pubmed.ncbi.nlm.nih.gov/14763711/M W Gries
https://pubmed.ncbi.nlm.nih.gov/6709254/Gustav Cornefjord, Ioannis Kostogiannis, Cecilia Rogmark...
https://pubmed.ncbi.nlm.nih.gov/37641082/P L Hudak, P C Amadio, C Bombardier
https://pubmed.ncbi.nlm.nih.gov/8773720/Daniel Wenger, Gustav Cornefjord, Cecilia Rogmark
https://pubmed.ncbi.nlm.nih.gov/34236459/Region Skane
Lead Sponsor
Lund University
Collaborating Sponsor