Wrist ArthritisMIKANCT03315377
Lunatocapitate Fusion Versus Four-corner Fusion for SNAC and SLAC Arthritis.
A study testing Lunate-Capitate Fusion (LCF) and Four Corner Fusion (4CF) in people with Wrist Arthritis, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Arthritis
- What is being tested?
- Lunate-Capitate Fusion (LCF) and Four Corner Fusion (4CF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2017to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SNAC or SLAC arthritis grade 2-3
Who cannot join
- SNAC or SLAC arthritis grade 4
- Inability to cooperate with the follow-up protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lunatocapitate Fusion Versus Four-corner Fusion for SNAC and SLAC Arthritis. A Randomized Comparison.
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).
Read the 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).
- Conditions
- Wrist Arthritis
- Being tested
- Lunate-Capitate Fusion (LCF), Four Corner Fusion (4CF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lunate-Capitate Fusion (LCF)Procedure or surgery
Operation with lunate-capitate-fusion (LCF)
Four Corner Fusion (4CF)Procedure or surgery
Operation with four-corner-fusion (4CF)
| Study group | Role | What they receive |
|---|---|---|
| Lunate-Capitate Fusion (LCF) | Active comparator | Operation with a Lunate-Capitate Fusion (LCF) for SLAC or SNAC arthritis. Receives: Procedure: Lunate-Capitate Fusion (LCF) |
| Four Corner Fusion (4CF) | Active comparator | Operation with a Four Corner Fusion (4CF) for SLAC or SNAC arthritis Receives: Procedure: Four Corner Fusion (4CF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
Hand grip strength measured with Jamar dynamometer
Measured: 1 year postoperatively
Secondary outcomes (6)
DASH score
Disability of the Arm, Hand and Shoulder (DASH) questionnaire
Measured: 1 year postoperatively
PRWE score
Patient Rated Wrist Evaluation (PRWE)
Measured: 1 year postoperatively
Range of motion (ROM)
Wrist ROM measured with a goniometer
Measured: 1 year postoperatively
EQ5D (for analysis of health economy)
Quality of life questionnaire
Measured: 1 year postoperatively
Complications
Infection, nonunion
Measured: 1 year postoperatively
Progress of arthritis
Radiological signs of radiocarpal arthritis on CT scans
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start1 Sep 2017
- Primary completion30 Apr 2023
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist ArthritisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Skane University Hospital
- Responsible party
- Principal investigator, Thorsten Schriever, Karolinska Institutet
- Investigators
- Maria Wilcke, MD, PhD, Study director, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315377
- Sponsor's protocol ID
- MIKA1
- Acronym
- MIKA
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2017
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lunatocapitate Fusion Versus Four-corner Fusion for SNAC and SLAC Arthritis. A Randomized Comparison.
- ClinicalTrials.gov ID
- NCT03315377
- Acronym / sponsor ID
- MIKA / MIKA1
- Conditions
- Wrist Arthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Skane University Hospital
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lunate-Capitate Fusion (LCF) | Active comparator | Procedure: Lunate-Capitate Fusion (LCF)Operation with a Lunate-Capitate Fusion (LCF) for SLAC or SNAC arthritis. |
| Four Corner Fusion (4CF) | Active comparator | Procedure: Four Corner Fusion (4CF)Operation with a Four Corner Fusion (4CF) for SLAC or SNAC arthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- SNAC or SLAC arthritis grade 2-3
Key exclusion criteria (2 listed)
- SNAC or SLAC arthritis grade 4
- Inability to cooperate with the follow-up protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lunate-Capitate Fusion (LCF)Operation with lunate-capitate-fusion (LCF) | Procedure or surgery | Lunate-Capitate Fusion (LCF) |
| Four Corner Fusion (4CF)Operation with four-corner-fusion (4CF) | Procedure or surgery | Four Corner Fusion (4CF) |
Primary outcome
Grip strength
Time frame: 1 year postoperatively
Hand grip strength measured with Jamar dynamometer
6 secondary outcomes
DASH score
Time frame: 1 year postoperatively
PRWE score
Time frame: 1 year postoperatively
Range of motion (ROM)
Time frame: 1 year postoperatively
EQ5D (for analysis of health economy)
Time frame: 1 year postoperatively
Complications
Time frame: 1 year postoperatively
Progress of arthritis
Time frame: 1 year postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Wilcke, MD, PhD study director
Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lunate-Capitate Fusion (LCF) and Four Corner Fusion (4CF) in people with Wrist Arthritis, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip strength (time frame: 1 year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.