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NCT Number: NCT03315377

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Handsurgery SÖS

Stockholm, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lunate-Capitate Fusion (LCF)

Procedure

Operation with lunate-capitate-fusion (LCF)

Four Corner Fusion (4CF)

Procedure

Operation with four-corner-fusion (4CF)

Primary outcomes

  1. Grip strength

    Time frame: 1 year postoperatively

    Hand grip strength measured with Jamar dynamometer

Secondary outcomes

  1. DASH score

    Time frame: 1 year postoperatively

    Disability of the Arm, Hand and Shoulder (DASH) questionnaire

  2. PRWE score

    Time frame: 1 year postoperatively

    Patient Rated Wrist Evaluation (PRWE)

  3. Range of motion (ROM)

    Time frame: 1 year postoperatively

    Wrist ROM measured with a goniometer

  4. EQ5D (for analysis of health economy)

    Time frame: 1 year postoperatively

    Quality of life questionnaire

  5. Complications

    Time frame: 1 year postoperatively

    Infection, nonunion

  6. Progress of arthritis

    Time frame: 1 year postoperatively

    Radiological signs of radiocarpal arthritis on CT scans

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Skane University Hospital

Registry information

Official study title

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

Acronym: MIKA

Important dates

Study start
2017
Primary completion
2023
Study completion
2027
First posted
Oct 20, 2017
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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