NCT01871272

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
491

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 30, 2015

Status Verified

June 1, 2015

Enrollment Period

2.3 years

First QC Date

June 3, 2013

Last Update Submit

June 29, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up.

  • Patient Acceptable Symptom State (PASS)

    At 12 weeks and 52 weeks follow-up.

  • Treatment failure (TF)

    At 12 weeks and 52 weeks follow-up.

Other Outcomes (1)

  • Global perceived effect (GPE)

    At 12 weeks and 52 weeks follow-up.

Study Arms (1)

Meniscus Injury Patients

Patients having surgery for a meniscal tear.

Procedure: Arthroscopic Meniscus Surgery

Interventions

Surgery to the meniscus - resection or repair.

Meniscus Injury Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Orthopedics, Lillebaelt Hospital

Kolding, Southern Denmark, 6000, Denmark

Location

Department of Orthopedics and Traumatology, Odense University Hospital

Odense, Southern Denmark, 5000, Denmark

Location

Department of Orthopedics and Traumatology, Odense University Hospital

Svendborg, Southern Denmark, 5700, Denmark

Location

Department of Orthopedics, Lillebaelt Hospital

Vejle, Southern Denmark, 7100, Denmark

Location

Related Publications (5)

  • 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.

    PMID: 24127057BACKGROUND
  • Giladi 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.

  • Pihl 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.

  • Thorlund 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.

  • Thorlund 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.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jonas B Thorlund, PhD

    Department of Sports Science and Clinical Biomechanics, University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 6, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 30, 2015

Record last verified: 2015-06

Locations