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New treatment option for Scaphoid Fracture
Official title Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion
ClinicalTrials.gov ID: NCT05574582
What this study is testing
- What it's testing
- Single site, prospective, observer-blinded randomized controlled trial. Eighty-eight patients aged 18-68 years with scaphoid delayed/non-union, will be randomized, 1:1, to either open iliac crest cancellous graft reconstruction or arthroscopic assisted distal radius cancellous chips graft reconstruction.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 68
You may be able to join if
- Patients aged 18-68 years.
- A scaphoid fracture without healing 2-6 months since fracture (delayed union) for cases with either displacement \>1mm or comminution and failed...
- Scaphoid fracture without healing \>6 months since fracture (non-union) regardless of displacement, comminution and if previous non-operative...
- ASA 1-3.
You likely can't join if
- Open fractures
- Associated trans-scaphoid perilunate dislocation.
- Associated fracture in the hand/upper extremity.
- Previous failed surgical treatment for scaphoid delayed/non-union.
- Stage 2 SNAC or above.
- Avascular necrosis of the proximal pole as evaluated with MRI and absence of punctate bleeding intraoperatively.
See the full eligibility criteria
- Patients aged 18-68 years.
- A scaphoid fracture without healing 2-6 months since fracture (delayed union) for cases with either displacement \>1mm or comminution and failed non-operative treatment.
- Scaphoid fracture without healing \>6 months since fracture (non-union) regardless of displacement, comminution and if previous non-operative treatment has been tried.
- ASA 1-3.
- Open fractures
- Associated trans-scaphoid perilunate dislocation.
- Associated fracture in the hand/upper extremity.
- Previous failed surgical treatment for scaphoid delayed/non-union.
- Stage 2 SNAC or above.
- Avascular necrosis of the proximal pole as evaluated with MRI and absence of punctate bleeding intraoperatively.
- Patients with gross humpback deformity of HLR \>0.75 and/or DCA \<70⁰.
- Patients unable to understand instructions in Danish, complete the rehabilitation protocol, or answering the questionnaires because of physical or cognitive impairment, as evaluated by the surgeon at the first visit.
The study team makes the final eligibility decision.
Where it's taking place
- Hellerup, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 68 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hellerup, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.