The Use of Proximal Carpal Row Versus Iliac Crest as Bone Graft in Total Wrist Fusion
NCT ID: NCT04403958
Last Updated: 2021-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2021-09-01
2024-12-31
Brief Summary
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Patients with radiologically and clinically confirmed advanced osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either total wrist arthrodesis with PRC or TWA with iliac crest bone grafting.
Baseline data is collected preoperatively and is a follow-up visits at every 6 weeks after the surgery is arranged until the wrist is fused. The primary end-point is 6 months and the primary outcome is fusion rate.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PRC
Total wrist arthrodesis with PRC and dorsal plate
PRC
Total wrist arthrodesis with dorsal plate using proximal row of the wrist as bone graft
TWA
Total wrist arthrodesis with dorsal plate
TWA
Total wrist arthrodesis with dorsal plate using iliac crest as bone graft
Interventions
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PRC
Total wrist arthrodesis with dorsal plate using proximal row of the wrist as bone graft
TWA
Total wrist arthrodesis with dorsal plate using iliac crest as bone graft
Eligibility Criteria
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Inclusion Criteria
* Symptom duration \> 3 months
* American Society of Anaesthesiologists physical status (ASA) I-III
* Fluent in written and spoken Finnish
Exclusion Criteria
* Rheumatoid arthritis
* Heavy smoking (\> 20 cigarettes per day)
* Condition or medication affecting bony healing (eg diabetes mellitus with poor glycemic control, malnutrition, use of per oral corticosteroids)
* Ulnar variance \> 1 mm
* Wrist pain treatable with partial wrist fusion
* Previous partial wrist fusion
* Alcohol or drug abuse
* Neurological condition affecting upper limb function
* Less than 6 months after another operation of the same upper limb
18 Years
75 Years
ALL
No
Sponsors
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Turku University Hospital
OTHER_GOV
Kymenlaakso Central Hospital Kotka Finland
OTHER
Töölö Hospital
OTHER
Responsible Party
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Samuli Aspinen
Principal investigator
Principal Investigators
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Samuli Aspinen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
HUS Töölö Hospital
Central Contacts
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Other Identifiers
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1467/2020
Identifier Type: -
Identifier Source: org_study_id
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