NCT03315377

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Sep 2017Apr 2027

First Submitted

Initial submission to the registry

August 21, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Expected
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

5.7 years

First QC Date

August 21, 2017

Last Update Submit

August 31, 2025

Conditions

Wrist Arthritis

Outcome Measures

Primary Outcomes (1)

  • Grip strength

    Hand grip strength measured with Jamar dynamometer

    1 year postoperatively

Secondary Outcomes (6)

  • DASH score

    1 year postoperatively

  • PRWE score

    1 year postoperatively

  • Range of motion (ROM)

    1 year postoperatively

  • EQ5D (for analysis of health economy)

    1 year postoperatively

  • Complications

    1 year postoperatively

  • +1 more secondary outcomes

Study Arms (2)

Lunate-Capitate Fusion (LCF)

ACTIVE COMPARATOR

Operation with a Lunate-Capitate Fusion (LCF) for SLAC or SNAC arthritis.

Procedure: Lunate-Capitate Fusion (LCF)

Four Corner Fusion (4CF)

ACTIVE COMPARATOR

Operation with a Four Corner Fusion (4CF) for SLAC or SNAC arthritis

Procedure: Four Corner Fusion (4CF)

Interventions

Lunate-Capitate Fusion (LCF)PROCEDURE

Operation with lunate-capitate-fusion (LCF)

Lunate-Capitate Fusion (LCF)
Four Corner Fusion (4CF)PROCEDURE

Operation with four-corner-fusion (4CF)

Four Corner Fusion (4CF)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- SNAC or SLAC arthritis grade 2-3

You may not qualify if:

  • SNAC or SLAC arthritis grade 4
  • Inability to cooperate with the follow-up protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Handsurgery SÖS

Stockholm, Sweden

Location

Study Officials

  • Maria Wilcke, MD, PhD

    Stockholm, Sweden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 21, 2017

First Posted

October 20, 2017

Study Start

September 1, 2017

Primary Completion

April 30, 2023

Study Completion (Estimated)

April 30, 2027

Last Updated

September 8, 2025

Record last verified: 2025-08

Locations

SE(1)