Meniscus InjuryKACSNCT01871272
Knee Arthroscopy Cohort Southern Denmark (KACS)
An observational study of Meniscus Injury and Knee Osteoarthritis, run by University of Southern Denmark at 4 sites in Denmark.
Trial summary
PURPOSE: To investigate the natural time course of patient-reported outcomes after meniscus surgery and identify factors associated with good and bad outcome after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniscus Injury, Knee Osteoarthritis
- What is being tested?
- Arthroscopic Meniscus Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 491 participants
- Where
- 4 sitesDenmark
- Study dates
- Feb 2013to Jun 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients assigned for arthroscopy on suspicion of a meniscus tear in the period from February 1st 2013 to January 31st 2014 will be consecutively recruited to the KACS cohort from 4 different hospitals (Lillebaelt Hospital - Kolding and Vejle and Odense University Hospital - Odense and Svendborg) in the Region of Southern Denmark.
Who may be able to join
- Assigned for arthroscopy on suspicion of a medial and/or lateral meniscus tear.
- Age >18 years at time of recruitment
- Having an email address
- Able to read and understand Danish
Who cannot join
- Patients who will or have previously undergone surgical reconstruction of the anterior or posterior cruciate ligament (ACL or PCL) in either knee
- Fracture to the lower extremities (i.e. hip, leg or foot) in either leg within the last 6 months prior to recruitment
- Not mentally able to reply to the questionnaire
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Department of Orthopedics, Lillebaelt Hospital
Kolding, Southern Denmark, 6000
Department of Orthopedics and Traumatology, Odense University Hospital
Odense, Southern Denmark, 5000
Department of Orthopedics and Traumatology, Odense University Hospital
Svendborg, Southern Denmark, 5700
Department of Orthopedics, Lillebaelt Hospital
Vejle, Southern Denmark, 7100
About this study
PURPOSE: To investigate the natural time course of patient-reported outcomes after meniscus surgery and identify factors associated with good and bad outcome after surgery.
- Conditions
- Meniscus Injury, Knee Osteoarthritis
- Being tested
- Arthroscopic Meniscus Surgery
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Meniscus SurgeryProcedure or surgery
Surgery to the meniscus - resection or repair.
| Study group | Role | What they receive |
|---|---|---|
| Meniscus Injury Patients | Patients having surgery for a meniscal tear. Receives: Procedure: Arthroscopic Meniscus Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee specific questionnaire. All domains on the KOOS. Primary end point is change from PRE surgery (assessed 1-14 days prior to surgery) to 52 weeks follow-up.
Measured: PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up
Secondary outcomes (3)
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
Generic health survey questionnaire.
Measured: PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up.
Patient Acceptable Symptom State (PASS)
Dichotomous outcome (y/n) to the question: "Considering your knee function, do you feel that your current state is satisfactory? With knee function you should take into account all activities you have during your daily life, sport and recreational activities, your level of pain and other symptoms, and also your knee related quality of life".
Measured: At 12 weeks and 52 weeks follow-up.
Treatment failure (TF)
Patients replying "no" to the PASS question will also be asked to answer (y/n) the following question: "Would you consider your current state as being so unsatisfactory that you think the treatment has failed?". Patients replying, "yes" to the second question will be defined as experiencing "treatment failure" (TF).
Measured: At 12 weeks and 52 weeks follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Meniscus InjuryStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Lillebaelt Hospital, Kolding and Vejle, Denmark
- Responsible party
- Principal investigator, Jonas Bloch Thorlund, University of Southern Denmark
- Investigators
- Jonas B Thorlund, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871272
- Sponsor's protocol ID
- 2012-41-1411
- Other IDs
- #12-125457, #12/6334
- Acronym
- KACS
- Status last verified
- Jun 2015
- First submitted
- 3 Jun 2013
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Thorlund JB, Christensen R, Nissen N, Jorgensen U, Schjerning J, Porneki JC, Englund M, Lohmander LS. Knee Arthroscopy Cohort Southern Denmark (KACS): protocol for a prospective cohort study. BMJ Open. 2013 Oct 14;3(10):e003399. doi: 10.1136/bmjopen-2013-003399.
PubMed 24127057Giladi JO, Holsgaard-Larsen A, Varnum C, Thorlund JB. Sports Participation and Performance 5 Years After Arthroscopic Partial Meniscectomy: A Retrospective Cohort Study of 288 Patients. J Orthop Sports Phys Ther. 2022 Apr;52(4):224-232. doi: 10.2519/jospt.2022.10785.
PubMed 35442751Pihl K, Ensor J, Peat G, Englund M, Lohmander S, Jorgensen U, Nissen N, Fristed JV, Thorlund JB. Wild goose chase - no predictable patient subgroups benefit from meniscal surgery: patient-reported outcomes of 641 patients 1 year after surgery. Br J Sports Med. 2020 Jan;54(1):13-22. doi: 10.1136/bjsports-2018-100321. Epub 2019 Jun 11.
PubMed 31186258Thorlund JB, Pihl K, Nissen N, Jorgensen U, Fristed JV, Lohmander LS, Englund M. Conundrum of mechanical knee symptoms: signifying feature of a meniscal tear? Br J Sports Med. 2019 Mar;53(5):299-303. doi: 10.1136/bjsports-2018-099431. Epub 2018 Aug 31.
PubMed 30170997Thorlund JB, Englund M, Christensen R, Nissen N, Pihl K, Jorgensen U, Schjerning J, Lohmander LS. Patient reported outcomes in patients undergoing arthroscopic partial meniscectomy for traumatic or degenerative meniscal tears: comparative prospective cohort study. BMJ. 2017 Feb 2;356:j356. doi: 10.1136/bmj.j356.
PubMed 28153861
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Arthroscopy Cohort Southern Denmark (KACS)
- ClinicalTrials.gov ID
- NCT01871272
- Acronym / sponsor ID
- KACS / 2012-41-1411
- Conditions
- Meniscus Injury, Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Lillebaelt Hospital, Kolding and Vejle, Denmark
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Jun 2013 (estimated)
- 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.
PURPOSE: To investigate the natural time course of patient-reported outcomes after meniscus surgery and identify factors associated with good and bad outcome after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meniscus Injury Patients | – | Procedure: Arthroscopic Meniscus SurgeryPatients having surgery for a meniscal tear. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients assigned for arthroscopy on suspicion of a meniscus tear in the period from February 1st 2013 to January 31st 2014 will be consecutively recruited to the KACS cohort from 4 different hospitals (Lillebaelt Hospital - Kolding and Vejle and Odense University Hospital - Odense and Svendborg) in the Region of Southern Denmark.
Key inclusion criteria (4 listed)
- Assigned for arthroscopy on suspicion of a medial and/or lateral meniscus tear.
- Age >18 years at time of recruitment
- Having an email address
- Able to read and understand Danish
Key exclusion criteria (3 listed)
- Patients who will or have previously undergone surgical reconstruction of the anterior or posterior cruciate ligament (ACL or PCL) in either knee
- Fracture to the lower extremities (i.e. hip, leg or foot) in either leg within the last 6 months prior to recruitment
- Not mentally able to reply to the questionnaire
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 |
|---|---|---|
| Arthroscopic Meniscus SurgerySurgery to the meniscus - resection or repair. | Procedure or surgery | Meniscus Injury Patients |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up
Knee specific questionnaire. All domains on the KOOS. Primary end point is change from PRE surgery (assessed 1-14 days prior to surgery) to 52 weeks follow-up.
3 secondary outcomes
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
Time frame: PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up.
Patient Acceptable Symptom State (PASS)
Time frame: At 12 weeks and 52 weeks follow-up.
Treatment failure (TF)
Time frame: At 12 weeks and 52 weeks follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
- Background: PubMed 24127057Thorlund JB, Christensen R, Nissen N, Jorgensen U, Schjerning J, Porneki JC, Englund M, Lohmander LS. Knee Arthroscopy Cohort Southern Denmark (KACS): protocol for a prospective cohort study. BMJ Open. 2013 Oct 14;3(10):e003399. doi: 10.1136/bmjopen-2013-003399.
- Derived from this study: PubMed 35442751Giladi JO, Holsgaard-Larsen A, Varnum C, Thorlund JB. Sports Participation and Performance 5 Years After Arthroscopic Partial Meniscectomy: A Retrospective Cohort Study of 288 Patients. J Orthop Sports Phys Ther. 2022 Apr;52(4):224-232. doi: 10.2519/jospt.2022.10785.
- Derived from this study: PubMed 31186258Pihl K, Ensor J, Peat G, Englund M, Lohmander S, Jorgensen U, Nissen N, Fristed JV, Thorlund JB. Wild goose chase - no predictable patient subgroups benefit from meniscal surgery: patient-reported outcomes of 641 patients 1 year after surgery. Br J Sports Med. 2020 Jan;54(1):13-22. doi: 10.1136/bjsports-2018-100321. Epub 2019 Jun 11.
- Derived from this study: PubMed 30170997Thorlund JB, Pihl K, Nissen N, Jorgensen U, Fristed JV, Lohmander LS, Englund M. Conundrum of mechanical knee symptoms: signifying feature of a meniscal tear? Br J Sports Med. 2019 Mar;53(5):299-303. doi: 10.1136/bjsports-2018-099431. Epub 2018 Aug 31.
- Derived from this study: PubMed 28153861Thorlund JB, Englund M, Christensen R, Nissen N, Pihl K, Jorgensen U, Schjerning J, Lohmander LS. Patient reported outcomes in patients undergoing arthroscopic partial meniscectomy for traumatic or degenerative meniscal tears: comparative prospective cohort study. BMJ. 2017 Feb 2;356:j356. doi: 10.1136/bmj.j356.
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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. This study is not recruiting at the moment.
Jonas B Thorlund, PhD principal investigator
University of Southern Denmark
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus Injury and Knee Osteoarthritis, run by University of Southern Denmark at 4 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Injury and Osteoarthritis Outcome Score (KOOS) (time frame: PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up). 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 NCT01871272, which also lists 5 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 30 Jun 2015; AzTrials last refreshed its copy on 2 Nov 2026.