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Anterior Cruciate Ligament InjuryACLLTFUNCT03182647

Long-term Follow-up of Anterior Cruciate Ligament Injury

An observational study of Anterior Cruciate Ligament Injury, run by Linkoeping University at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Anterior cruciate ligament (ACL) rupture is one of the most common sports-related knee injuries. Because it is such a significant injury - requiring a long period of rehabilitation before the injured person is ready to return to physical activity, the burden of injury is high. Read more about this study

Who is it for?
Ages 47 to 77 years
Conditions the study is for
Anterior Cruciate Ligament Injury
What is being tested?
Surgically treatment of the ACL and Non surgical initial ACL treatment
Type of treatment
Surgery or procedure
How many people
300 participants
Where
1 siteSweden
Study dates
9 Jun 2017to 30 Jun 2018
Phase
Observational
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 47 to 77 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Baseline data from the time for injury were collected consequently. The initial 167 patients were included in a randomised clinical trial of surgical vs. non-surgical treatment and the following patients were treated according to common practise at that time.

Who may be able to join

  • primary ACL injury between 1980 and 1985, age between 15 and 40 at injury

Who cannot join

  • all patients from the initial cohort will be invited for participation

Trial locations and contacts

1 site in 1 country.

Joanna Kvist, Professor contact

+4613284664

joanna.kvist@liu.se

Sweden1 site, 1 recruiting

  • Linkoping University

    Linköping, Östergötland County, 58183

    Joanna Kvist, Professor, +46 (0) 13 284664, joanna.kvist@liu.se

    Joanna Kvist, Professor

    Recruiting

Other trials in Sweden

About this study

Anterior cruciate ligament (ACL) rupture is one of the most common sports-related knee injuries. Because it is such a significant injury - requiring a long period of rehabilitation before the injured person is ready to return to physical activity, the burden of injury is high. This can help to explain why so much of orthopaedic research is devoted to evaluating the outcomes of ACL injury. However, while there has been extensive study of short-term (up to 5 years after injury) outcomes, few studies have followed patients beyond 15 years after their ACL injury. This is important because long-term follow-up can provide key insights to guide the information provided to newly injured patients (e.g. to help set realistic expectations of what the injured person can expect of their knee function in the future), and help us evaluate the efficacy of previous treatments.

The primary aim is to assess the influence of an acute ACL injury on knee function and quality of life, 32-37 years after the index injury. Approximately 300 patients injured between 1980 and 1985 will be invited to participate in the study. Patient- and clinician-reported outcomes, and radiographic osteoarthritis will be evaluated.

Read the detailed description

Patients injuring their ACL between 1980 and 1985 have periodically been followed since the injury. Now, we plan to contact all patients and invite them to participate. The patients will be asked to

  1. complete a questionnaire battery
  2. visit the movement laboratory at Linköping University for an objective assessment of knee function and
  3. have an x-ray of both knee joints.

Baseline information including associated injuries, treatment and activity level exist for all the patients. At that time, rehabilitation was normally completed after 4-6 months for non-operatively treated patients, and nine months after ACL surgery.

Being tested
Surgically treatment of the ACL, Non surgical initial ACL treatment
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.

  • Surgically treatment of the ACLProcedure or surgery

    Surgical initial ACL treatment

  • Non surgical initial ACL treatmentOther

    Non surgical initial ACL treatment

Study groups in NCT03182647
Study groupRoleWhat they receive
Non surgeryPatients were not treated with surgery initially
Receives: Other: Non surgical initial ACL treatment
SurgeryPatients had an initial surgical treatment
Receives: Procedure: Surgically treatment of the ACL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self reported knee function

    Knee Injury and Osteoarthritis Outcome Score, KOOS 4 (Pain, Symptoms, Sport/Rec, QOL subscales)

    Measured: 32-37 years after ACL injury

  2. Osteoarthritis

    Development of osteoarthritis examined with tibiofemoral and patellofemoral radiographs

    Measured: 32-37 years after ACL injury

Secondary outcomes (7)

  1. Quality of life

    ACL-Quality of Life scale (ACL-QoL)

    Measured: 32-37 years after ACL injury

  2. Physical activity

    Total time over the previous week spent doing moderate, and vigorous activity AND accelerometer measures

    Measured: 32-37 years after ACL injury

  3. Objective assessment of knee function

    Concentric isokinetic muscle strength

    Measured: 32-37 years after ACL injury

  4. Objective assessment of knee function

    Functional testing; stand-up test

    Measured: 32-37 years after ACL injury

  5. Objective assessment of knee function

    Functional testing; hopping performance in one leg hop for distance

    Measured: 32-37 years after ACL injury

  6. Objective assessment of knee function

    Postural control (one leg stand test)

    Measured: 32-37 years after ACL injury

  7. Associated injuries and additional surgery

    Patient reported

    Measured: 32-37 years after ACL injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2017
  2. Study start9 Jun 2017
  3. Primary completion31 Dec 2017 (estimated)
  4. Study completion30 Jun 2018 (estimated)

Resources

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
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03182647
Sponsor's protocol ID
ACL LTFU
Acronym
ACLLTFU
Status last verified
Jun 2017
First submitted
5 Jun 2017
Last updated
2 Jul 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Meunier A, Odensten M, Good L. Long-term results after primary repair or non-surgical treatment of anterior cruciate ligament rupture: a randomized study with a 15-year follow-up. Scand J Med Sci Sports. 2007 Jun;17(3):230-7. doi: 10.1111/j.1600-0838.2006.00547.x.

    PubMed 17501866

  • Andersson C, Odensten M, Gillquist J. Knee function after surgical or nonsurgical treatment of acute rupture of the anterior cruciate ligament: a randomized study with a long-term follow-up period. Clin Orthop Relat Res. 1991 Mar;(264):255-63.

    PubMed 1997243

  • Filbay S, Andersson C, Gauffin H, Kvist J. Prognostic Factors for Patient-Reported Outcomes at 32 to 37 Years After Surgical or Nonsurgical Management of Anterior Cruciate Ligament Injury. Orthop J Sports Med. 2021 Aug 11;9(8):23259671211021592. doi: 10.1177/23259671211021592. eCollection 2021 Aug.

    PubMed 34395684

  • Kvist J, Filbay S, Andersson C, Ardern CL, Gauffin H. Radiographic and Symptomatic Knee Osteoarthritis 32 to 37 Years After Acute Anterior Cruciate Ligament Rupture. Am J Sports Med. 2020 Aug;48(10):2387-2394. doi: 10.1177/0363546520939897.

    PubMed 32736511

Questions about this trial

What is this clinical trial studying?

An observational study of Anterior Cruciate Ligament Injury, run by Linkoeping University 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 1 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: status not confirmed, as of the sponsor's last update on 2 Jul 2017. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Joanna Kvist, Professor (+4613284664, joanna.kvist@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self reported knee function (time frame: 32-37 years after ACL injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03182647, which also lists 4 linked publications.

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 2017.

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