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Lunatocapitate Fusion Versus Four-corner Fusion for SNAC and SLAC Arthritis.

Lunatocapitate Fusion Versus Four-corner Fusion for SNAC and SLAC Arthritis. A Randomized Comparison.

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03315377
Acronym
MIKA
Enrollment
64
Registered
2017-10-20
Start date
2017-09-01
Completion date
2027-04-30
Last updated
2025-09-08

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

Conditions

Wrist Arthritis

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).

Interventions

PROCEDURELunate-Capitate Fusion (LCF)

Operation with lunate-capitate-fusion (LCF)

PROCEDUREFour Corner Fusion (4CF)

Operation with four-corner-fusion (4CF)

Sponsors

Skane University Hospital
CollaboratorOTHER
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Grip strength1 year postoperativelyHand grip strength measured with Jamar dynamometer

Secondary

MeasureTime frameDescription
PRWE score1 year postoperativelyPatient Rated Wrist Evaluation (PRWE)
Range of motion (ROM)1 year postoperativelyWrist ROM measured with a goniometer
DASH score1 year postoperativelyDisability of the Arm, Hand and Shoulder (DASH) questionnaire
Complications1 year postoperativelyInfection, nonunion
Progress of arthritis1 year postoperativelyRadiological signs of radiocarpal arthritis on CT scans
EQ5D (for analysis of health economy)1 year postoperativelyQuality of life questionnaire

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026