Ligament InjuryNCT04348253
Danish Multicenter Scapholunate Ligament Study
A study testing Berger and 3LT in people with Ligament Injury and Wrist Sprain, run by University of Aarhus at 2 sites in Denmark.
Trial summary
Comparison of two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. A randomized multicenter study. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ligament Injury, Wrist Sprain
- What is being tested?
- Berger and 3LT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Aug 2018to 30 Apr 2033
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years (both included).
- Symptomatic SL instability (VAS score ³3, QDASH score ³ 20).
- > 6 weeks since symptomatic hand trauma (chronic SL lesions).
- SL gapping on radiographic stress views or SL gapping (³2mm) on static PA views.
- Complete SL ligament lesion confirmed by wrist arthroscopy
Who cannot join
- Geissler grade 1-3 SLL injury (evaluated by arthroscopy).
- Concomitant complete luno-triquetral (LT) ligament injury (evaluated by arthroscopy).
- Lesion of TFCC leading to DRUJ instability (evaluated by arthroscopy).
- Radiocarpal or midcarpal arthritis evaluated by arthroscopy.
- Previous fracture in carpus or intraarticular radius fracture with step off (³2 mm), disposing to posttraumatic arthritis.
- Adverse effects after extra articular radial fractures (dorsal angulation ³10 grader).
- Peroperatively non-reducible scaphoid flexion/SL gap.
- Terminal illness or severe medical illness: ASA score higher than or equal to 3.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Maiken Stilling, Professor
- Recruiting
Hospital Unit Vest
Holstebro, 7500
Janni K Thillemann, Dr, +4528137303, teamjanni@gmail.com
About this study
Official title: Reconstruction of Chronic Scapholunate Ligament Injuries in the Wrist: A Randomized Controlled Trial Comparing The Berger Capsulodesis and Three-Ligament-Tenodesis (3LT)
Comparison of two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. A randomized multicenter study.
Read the detailed description
This multicentre study aim to compare two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. The investigators compare patient reported, clinical and radiological outcomes up to 10 years after treatment of complete dynamic or static but reducible SL ligament lesions. The participants are randomized to two treatments. Effect parameters before and after intervention are compared between groups.
- Conditions
- Ligament Injury, Wrist Sprain
- Being tested
- Berger, 3LT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BergerProcedure or surgery
Treatment 1
3LTProcedure or surgery
Treatment 2
| Study group | Role | What they receive |
|---|---|---|
| Berger | Active comparator | Bergers capsulodesis Receives: Procedure: Berger |
| 3LT | Active comparator | Three ligament tenodesis Receives: Procedure: 3LT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)
points
Measured: At all follow-ups (0-10 years)
Secondary outcomes (4)
Grip-strength
kg
Measured: At all follow-ups (0-10 years)
SL angle
degrees
Measured: At all follow-ups (0-10 years)
The Patient-Rated Wrist Evaluation (PRWE) score
points
Measured: At all follow-ups (0-10 years)
Wrist motion
degrees
Measured: At all follow-ups (0-10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Aug 2018
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ligament InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janni K Thillemann, Dr, Principal investigator, Hospitalsenheden Vest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348253
- Sponsor's protocol ID
- 1-10-72-169-18
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of Chronic Scapholunate Ligament Injuries in the Wrist: A Randomized Controlled Trial Comparing The Berger Capsulodesis and Three-Ligament-Tenodesis (3LT)
- ClinicalTrials.gov ID
- NCT04348253
- Acronym / sponsor ID
- 1-10-72-169-18
- Conditions
- Ligament Injury, Wrist Sprain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2033 (estimated)
- First posted
- 16 Apr 2020 (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.
Comparison of two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. A randomized multicenter study.
Detailed description
This multicentre study aim to compare two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. The investigators compare patient reported, clinical and radiological outcomes up to 10 years after treatment of complete dynamic or static but reducible SL ligament lesions. The participants are randomized to two treatments. Effect parameters before and after intervention are compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized trial
| Arm | Type | Receives |
|---|---|---|
| Berger | Active comparator | Procedure: BergerBergers capsulodesis |
| 3LT | Active comparator | Procedure: 3LTThree ligament tenodesis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-60 years (both included).
- Symptomatic SL instability (VAS score ³3, QDASH score ³ 20).
- > 6 weeks since symptomatic hand trauma (chronic SL lesions).
- SL gapping on radiographic stress views or SL gapping (³2mm) on static PA views.
- Complete SL ligament lesion confirmed by wrist arthroscopy
Key exclusion criteria (8 listed)
- Geissler grade 1-3 SLL injury (evaluated by arthroscopy).
- Concomitant complete luno-triquetral (LT) ligament injury (evaluated by arthroscopy).
- Lesion of TFCC leading to DRUJ instability (evaluated by arthroscopy).
- Radiocarpal or midcarpal arthritis evaluated by arthroscopy.
- Previous fracture in carpus or intraarticular radius fracture with step off (³2 mm), disposing to posttraumatic arthritis.
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 |
|---|---|---|
| BergerTreatment 1 | Procedure or surgery | Berger |
| 3LTTreatment 2 | Procedure or surgery | 3LT |
Primary outcome
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)
Time frame: At all follow-ups (0-10 years)
points
4 secondary outcomes
Grip-strength
Time frame: At all follow-ups (0-10 years)
SL angle
Time frame: At all follow-ups (0-10 years)
The Patient-Rated Wrist Evaluation (PRWE) score
Time frame: At all follow-ups (0-10 years)
Wrist motion
Time frame: At all follow-ups (0-10 years)
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 16 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Janni K Thillemann, Dr principal investigator
Hospitalsenheden Vest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berger and 3LT in people with Ligament Injury and Wrist Sprain, run by University of Aarhus at 2 sites in Denmark.
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 5 inclusion and 8 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 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 Janni K Thillemann, Dr (+45 28137303, teamjanni@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) (time frame: At all follow-ups (0-10 years)). 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 16 Apr 2020.