Lunatocapitate Fusion Versus Four-corner Fusion for SNAC and SLAC Arthritis. (MIKA)
Primary Purpose
Wrist Arthritis
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Lunate-Capitate Fusion (LCF)
Four Corner Fusion (4CF)
Sponsored by
About this trial
This is an interventional treatment trial for Wrist Arthritis
Eligibility Criteria
Inclusion Criteria:
- SNAC or SLAC arthritis grade 2-3
Exclusion Criteria:
- SNAC or SLAC arthritis grade 4
- Inability to cooperate with the follow-up protocol
Sites / Locations
- Dept of Handsurgery SÖS
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lunate-Capitate Fusion (LCF)
Four Corner Fusion (4CF)
Arm Description
Operation with a Lunate-Capitate Fusion (LCF) for SLAC or SNAC arthritis.
Operation with a Four Corner Fusion (4CF) for SLAC or SNAC arthritis
Outcomes
Primary Outcome Measures
Grip strength
Hand grip strength measured with Jamar dynamometer
Secondary Outcome Measures
DASH score
Disability of the Arm, Hand and Shoulder (DASH) questionnaire
PRWE score
Patient Rated Wrist Evaluation (PRWE)
Range of motion (ROM)
Wrist ROM measured with a goniometer
EQ5D (for analysis of health economy)
Quality of life questionnaire
Complications
Infection, nonunion
Progress of arthritis
Radiological signs of radiocarpal arthritis on CT scans
Full Information
NCT ID
NCT03315377
First Posted
August 21, 2017
Last Updated
October 3, 2023
Sponsor
Karolinska Institutet
Collaborators
Skane University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03315377
Brief Title
Lunatocapitate Fusion Versus Four-corner Fusion for SNAC and SLAC Arthritis.
Acronym
MIKA
Official Title
Lunatocapitate Fusion Versus Four-corner Fusion for SNAC and SLAC Arthritis. A Randomized Comparison.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Skane University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypothesis: Lunate-capitate-fusion (LCF) results in comparable outcome (i.e. not worse) to four-corner-fusion (4CF) for Scaphoid Nonunion Advanced Collapse (SNAC) and Scapholunate Advanced Collapse (SLAC) arthritis regarding functional results (grip strength).
Design: Prospective randomised comparison. Inclusion criteria: SNAC or SLAC arthritis requiring a salvage procedure (grade 2-3).
Exclusion criteria: SNAC or SLAC arthritis grade 4 (panarthritis). Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder or drug addiction).
Detailed Description
Surgical method:
Patient will be operated in axially plexus with a dorsal approach through the 3d and 4th extensor tendon compartments. The wrist joint capsule will be opened with a Berger incision. After excision of the scaphoid and preparation of the articular surfaces to be fused, the bones will be fixated with k-wires. Bone autograft from the scaphoid, crista or radius will be used according to the surgeon's preference based on the condition of the fusion surfaces. The wrist be immobilized in a short arm plaster cast until the fusions are radiologically healed after10-12 weeks. The k-wires will be extracted in local anesthesia after another 2-6 weeks.
Sample size:
This study will have a power of 80% to show that the mean grip strength for LC fusion is as least as high as the mean for 4CF (non-inferiority). This assumes that the means for the LC fusion and the 4CF are equal (at 70% of the uninjured side) with a common within-group standard deviation of 14 (Salzman et al. 2015), that a difference of 10% or less is unimportant, that the sample size in the two groups will be 25 and 25, and the alpha (1 tailed) is set at 0,05.Formally, the null hypothesis is that the mean for lunocapitate fusion is 10% lower than the mean for 4CF, and that the study has power of 80,1% to reject this null. Equivalently, the likelihood is 80,1% that the 95% confidence interval for the mean difference will exclude a difference of 10% in favor of 4CF.
We aim to include 60 patients to cover for a certain loss to follow-up.
Assessment:
Patients will be assessed regarding range of motion and grip strength and complete the DASH and PRWE questionnaires before surgery (baseline) and 1 and 2 years postoperatively.
Radiology:
Plain anterior and lateral radiographs will be obtained 1 and 2 years postoperatively for purpose of the study. According to the standard treatment protocol, clinical and radiological healing assessment will be conducted 10-12 weeks postoperatively. Radiographs will be analyzed by a radiologist.
Complications will be recorded 1 and 2 years postoperatively.
Analyzes:
The Mann-Whitney and Chi-square tests will be used for non-parametric data (DASH, PRWE and presence of arthritis and complications). T-test will be used for numerical data (ROM, grip strength).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrist Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lunate-Capitate Fusion (LCF)
Arm Type
Active Comparator
Arm Description
Operation with a Lunate-Capitate Fusion (LCF) for SLAC or SNAC arthritis.
Arm Title
Four Corner Fusion (4CF)
Arm Type
Active Comparator
Arm Description
Operation with a Four Corner Fusion (4CF) for SLAC or SNAC arthritis
Intervention Type
Procedure
Intervention Name(s)
Lunate-Capitate Fusion (LCF)
Intervention Description
Operation with lunate-capitate-fusion (LCF)
Intervention Type
Procedure
Intervention Name(s)
Four Corner Fusion (4CF)
Intervention Description
Operation with four-corner-fusion (4CF)
Primary Outcome Measure Information:
Title
Grip strength
Description
Hand grip strength measured with Jamar dynamometer
Time Frame
1 year postoperatively
Secondary Outcome Measure Information:
Title
DASH score
Description
Disability of the Arm, Hand and Shoulder (DASH) questionnaire
Time Frame
1 year postoperatively
Title
PRWE score
Description
Patient Rated Wrist Evaluation (PRWE)
Time Frame
1 year postoperatively
Title
Range of motion (ROM)
Description
Wrist ROM measured with a goniometer
Time Frame
1 year postoperatively
Title
EQ5D (for analysis of health economy)
Description
Quality of life questionnaire
Time Frame
1 year postoperatively
Title
Complications
Description
Infection, nonunion
Time Frame
1 year postoperatively
Title
Progress of arthritis
Description
Radiological signs of radiocarpal arthritis on CT scans
Time Frame
1 year postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- SNAC or SLAC arthritis grade 2-3
Exclusion Criteria:
SNAC or SLAC arthritis grade 4
Inability to cooperate with the follow-up protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Wilcke, MD, PhD
Organizational Affiliation
Stockholm, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Dept of Handsurgery SÖS
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Lunatocapitate Fusion Versus Four-corner Fusion for SNAC and SLAC Arthritis.
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