Ligament; Laxity, KneeNCT03800225
Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study.
A study testing Repair in people with Ligament; Laxity, Knee and Anterior Cruciate Ligament Injury, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether anterior cruciate ligament injury in patients wishing to return to sports activities may be treated with repair supplemented with internal brace compared with a standard operation using a patella tendon autograft. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ligament; Laxity, Knee, Anterior Cruciate Ligament Injury
- What is being tested?
- Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jan 2019to 4 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anterior cruciate ligament rupture
Who cannot join
- Current malignant disease
- Rheumatoid arthritis
- Other knee ligament instability
- Obesity BMI >30
- Morbus Bechterew
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
Aarhus N, 8200
About this study
Official title: Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study Comparing Internal Brace Repair and a Patella Tendon Autograft Reconstruction.
The purpose of this study is to determine whether anterior cruciate ligament injury in patients wishing to return to sports activities may be treated with repair supplemented with internal brace compared with a standard operation using a patella tendon autograft.
- Being tested
- Repair
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RepairProcedure or surgery
Anterior ligament repair with internal brace.
| Study group | Role | What they receive |
|---|---|---|
| Repair | Experimental | Anterior cruciate ligament repair with internal brace after anterior ligament rupture. Receives: Procedure: Repair |
| Patella tendon graft | Active comparator | The Patella tendon graft is harvested and used as a knew anterior cruciate ligament after rupture. Receives: Procedure: Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Laxity
KT-1000 arthrometer
Measured: 12 Months
Secondary outcomes (3)
Patient reported outcome scores
Koos (Knee injury and Osteoarthritis Outcome Score)
Measured: 12 Months
Patient reported outcome scores
IKDC (International Knee Documentation Committee)
Measured: 12 Months
Pain measurement
NRS-pain score (Numeric rating scale) (10 worst pain - 0 No pain)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start3 Jan 2019
- Primary completion4 Sep 2019
- Study completion4 Sep 2019
Why it stopped: A new scientific study shows that surgery with internal brace is worse than convensional surgery tecnic. This new knowledge stops this trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ligament; Laxity, KneeStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Lind, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800225
- Sponsor's protocol ID
- Danish EC - 1-10-72-223-18.
- Status last verified
- Sep 2019
- First submitted
- 9 Jan 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study Comparing Internal Brace Repair and a Patella Tendon Autograft Reconstruction.
- ClinicalTrials.gov ID
- NCT03800225
- Acronym / sponsor ID
- Danish EC - 1-10-72-223-18.
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A new scientific study shows that surgery with internal brace is worse than convensional surgery tecnic. This new knowledge stops this trial.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 4 Sep 2019 (actual)
- Study completion
- 4 Sep 2019 (actual)
- First posted
- 11 Jan 2019 (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.
The purpose of this study is to determine whether anterior cruciate ligament injury in patients wishing to return to sports activities may be treated with repair supplemented with internal brace compared with a standard operation using a patella tendon autograft.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repair | Experimental | Procedure: RepairAnterior cruciate ligament repair with internal brace after anterior ligament rupture. |
| Patella tendon graft | Active comparator | Procedure: RepairThe Patella tendon graft is harvested and used as a knew anterior cruciate ligament after rupture. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anterior cruciate ligament rupture
Key exclusion criteria (5 listed)
- Current malignant disease
- Rheumatoid arthritis
- Other knee ligament instability
- Obesity BMI >30
- Morbus Bechterew
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 |
|---|---|---|
| RepairAnterior ligament repair with internal brace. | Procedure or surgery | Patella tendon graft, Repair |
Primary outcome
Knee Laxity
Time frame: 12 Months
KT-1000 arthrometer
3 secondary outcomes
Patient reported outcome scores
Time frame: 12 Months
Patient reported outcome scores
Time frame: 12 Months
Pain measurement
Time frame: 12 Months
Results and safety
The study was stopped early (reason given: A new scientific study shows that surgery with internal brace is worse than convensional surgery tecnic. This new knowledge stops this trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
Related trials for Ligament; Laxity, Knee
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty
Not yet recruitingObservational study
AI-Based Video Assessment of Anterior Knee Laxity
ACL - Anterior Cruciate Ligament Deficiency
RecruitingObservational study
Reference Values for Knee Rotational Amplitudes in a Population of Athletes
Knee Ligament Injury
Not yet recruitingObservational study
Measuring Knee Laxity and Pivot Shift in ACL-Deficient Patients
Anterior Cruciate Ligament (ACL) Tear
Recruiting
Ligament Balancing in Total Knee Arthroplasty
Ligament; Laxity, Knee, Knee Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair in people with Ligament; Laxity, Knee and Anterior Cruciate Ligament Injury, run by Aarhus University Hospital at 1 site 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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 2 Oct 2019. 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 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?
The study was stopped early (reason given: A new scientific study shows that surgery with internal brace is worse than convensional surgery tecnic. This new knowledge stops this trial.). Results are not available in the source record.
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?
Knee Laxity (time frame: 12 Months). 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 Oct 2019.