Scapholunate DissociationNCT07667114
Scapholunate Ligament Reconstruction Using Modified Flexor Carpi Radialis Tenodesis
An observational study of Scapholunate Dissociation and Scapholunate Ligament Rupture, run by Waldfriede Hospital at 1 site in Germany.
Trial summary
Retrospective study of patients who underwent a modified flexor carpi radialis (FCR) tenodesis for scapholunate ligament injury at Waldfriede Hospital during the period 2016-2026. Primary outcome: Functionality of the operated wrist measured using the validated DASH questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scapholunate Dissociation, Scapholunate Ligament Rupture
- What is being tested?
- modified flexor carpi radialis tenodesis
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2026to 31 May 2027
- Phase
- Observational
- 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
Study population: Participation in the study is offered to all eligible patients who underwent a modified flexor carpi radialis (FCR) tenodesis for an SL ligament injury at Waldfriede Hospital between 2016 and 2026.
Who may be able to join
- Age: ≥ 18 years
- Capable of providing informed consent independently
- Availability of written informed consent for the study
Who cannot join
- Active malignant disease
- Pregnancy at the time of the examination
- Presence of SLAC arthritis
- Lack of capacity to provide independent consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Waldfriede Hospital
Berlin, State of Berlin, 14163
Markus Bock, Dr. med., +493081810201, m.bock@waldfriede.de
About this study
Official title: Clinical Outcomes of Scapholunate Ligament Reconstruction Using Modified Flexor Carpi Radialis Tenodesis - A Retrospective Study From 2016-2026
Retrospective study of patients who underwent a modified flexor carpi radialis (FCR) tenodesis for scapholunate ligament injury at Waldfriede Hospital during the period 2016-2026.
Primary outcome: Functionality of the operated wrist measured using the validated DASH questionnaire.
- Being tested
- modified flexor carpi radialis tenodesis
- Keywords
- Scapholunate ligament, modified flexor carpi radialis (FCR) tenodesis, wrist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified flexor carpi radialis tenodesisProcedure or surgery
Flexor carpi radialis (FCR) tenodesis for the reconstruction of the dorsal scapholunate (SL) ligament and the dorsal intercarpal ligament (DICL)
What is being measured
The primary outcome is the main question the study is designed to answer.
DISABILITIES OF THE ARM, SHOULDER AND HAND (DASH) questionnaire
DISABILITIES OF THE ARM, SHOULDER AND HAND; This questionnaire asks about symptoms as well as the ability to do certain activities regarding the upper limbs. Measure uses a 0 to 100 scoring scale, where lower scores (close to 0) represent no disability, and higher scores (close to 100) indicate maximum severity or inability to perform.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Jul 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scapholunate DissociationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waldfriede Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667114
- Sponsor's protocol ID
- BB 112/26
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data must remain within the clinic, and we are not permitted to share the raw data publicly or upon request with external researchers as this is the standard practice for retrospective data due to data protection/GDPR
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Scapholunate Ligament Reconstruction Using Modified Flexor Carpi Radialis Tenodesis - A Retrospective Study From 2016-2026
- ClinicalTrials.gov ID
- NCT07667114
- Acronym / sponsor ID
- BB 112/26
- Keywords
- Scapholunate ligament, modified flexor carpi radialis (FCR) tenodesis, wrist
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Waldfriede HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 24 Jun 2026 (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.
Retrospective study of patients who underwent a modified flexor carpi radialis (FCR) tenodesis for scapholunate ligament injury at Waldfriede Hospital during the period 2016-2026.
Primary outcome: Functionality of the operated wrist measured using the validated DASH questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participation in the study is offered to all eligible patients who underwent a modified flexor carpi radialis (FCR) tenodesis for an SL ligament injury at Waldfriede Hospital between 2016 and 2026.
Key inclusion criteria (3 listed)
- Age: ≥ 18 years
- Capable of providing informed consent independently
- Availability of written informed consent for the study
Key exclusion criteria (4 listed)
- Active malignant disease
- Pregnancy at the time of the examination
- Presence of SLAC arthritis
- Lack of capacity to provide independent consent
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 |
|---|---|---|
| modified flexor carpi radialis tenodesisFlexor carpi radialis (FCR) tenodesis for the reconstruction of the dorsal scapholunate (SL) ligament and the dorsal intercarpal ligament (DICL) | Procedure or surgery | – |
Primary outcome
DISABILITIES OF THE ARM, SHOULDER AND HAND (DASH) questionnaire
Time frame: At enrollment
DISABILITIES OF THE ARM, SHOULDER AND HAND; This questionnaire asks about symptoms as well as the ability to do certain activities regarding the upper limbs. Measure uses a 0 to 100 scoring scale, where lower scores (close to 0) represent no disability, and higher scores (close to 100) indicate maximum severity or inability to perform.
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 2 Jul 2026.
- Individual participant dataSharing planned: No. Data must remain within the clinic, and we are not permitted to share the raw data publicly or upon request with external researchers as this is the standard practice for retrospective data due to data protection/GDPR
Related trials for Scapholunate Dissociation
Active, not recruitingObservational study
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Scapholunate Interosseous Ligament Injury, Scaphoid-Lunate Instability
Not yet recruiting
Diagnosing Dynamic Scapholunate Instability with Computer Tomography
Scapholunate Dissociation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scapholunate Dissociation and Scapholunate Ligament Rupture, run by Waldfriede Hospital at 1 site in Germany.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Jul 2026. 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 Germany. 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?
Contact Markus Bock, Dr. med. (+493081810200, m.bock@waldfriede.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DISABILITIES OF THE ARM, SHOULDER AND HAND (DASH) questionnaire (time frame: At enrollment). 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 2 Jul 2026.