Development of Knee Osteoarthritis After Arthroscopic Par... | NCT01052233

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jan 2016Estimated

Completion Date

Jan 2024Estimated

First Submitted Date

Jan 19, 2010

First Submission Date that Met QC Criteria

Jan 19, 2010

First Posted Date

Jan 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2015

Last Update Posted Date

Jan 21, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Teppo Jarvinen, Principal Investigator, Tampere UniversityPrincipal Investigator

Lead Sponsor

Tampere UniversityOTHER

Collaborators

Name	Class
Helsinki University Central Hospital	OTHER
Turku University Hospital	OTHER_GOV
Kuopio University Hospital	OTHER
Central Finland Hospital District

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

It has been previously demonstrated that the risk for the development of knee osteoarthritis is increased after both meniscus tear and meniscectomy. However, it is still unclear whether this is due to the meniscus tear per se, the surgery, or whether the development of knee osteoarthritis is completely independent of the two. Accordingly, the aim of the study is to investigate the effect of arthroscopic partial meniscectomy on the development of knee osteoarthritis 2 to 10 years after the procedure.

Detailed Description

It has been previously demonstrated that the risk for the development/progression of knee osteoarthritis is increased after both meniscus tear and meniscectomy. However, it is still unclear whether this is due to the meniscus tear per se (i.e., adverse mechanical effect on knee cartilage), the surgery (resection of the meniscus, and subsequent loss of cushion within the knee), or whether the development of knee osteoarthritis is completely independent of the two.

Accordingly, the aim of the study is to investigate the effect of Arthroscopic partial meniscectomy on the development of knee osteoarthritis 2 to 10 years after the procedure.

Patients included in the study will be randomized into one of two groups: arthroscopic partial meniscectomy and diagnostic arthroscopy (sham-surgery). The presence of knee osteoarthritis will be assessed preoperatively and 2, 5, and 10 years after the operation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arthroscopic partial meniscectomy	Active Comparator	Arthroscopic partial resection of degenerative tear of medial meniscus	Procedure: Arthroscopic partial meniscectomy
Arthroscopy (diagnostic)	Sham Comparator	Diagnostic arthroscopy of the knee	Procedure: Arthroscopy (diagnostic)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arthroscopic partial meniscectomy	Procedure	Arthroscopic partial meniscectomy of the degenerative tear of medial meniscus	Arthroscopic partial meniscectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiological assessment of OA of the knee (Kellgren-Lawrence -classification)		2 and 10 years postoperatively

Secondary Outcomes

Measure	Description	Time Frame
ACR (The American College of Rheumatology) clinical criteria for Osteoarthritis of the knee		2 and 10 years postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 35 to 65 years of age.
A pain located on the medial joint line of the knee that has persistent at least for 3 months.
Pain that can be provoked by palpation or compression of the joint line or a positive McMurray sign.
Tear of the medial meniscus on MRI.
Degenerative rupture of the medial meniscus confirmed at arthroscopy.

Exclusion Criteria:

Acute, trauma-induced onset of symptoms.
Locking or painful snapping of the knee joint.
A surgical operation performed on the affected knee.
Osteoarthritis of the medial compartment of the knee (determined by clinical criteria of the ACR).
Osteoarthritis on knee radiographs (Kellgren-Lawrence > 1).
Acute (within the previous year) fractures of the knee.
Decreased range of motion of the knee.
Instability of the knee.
MRI assessment showing a tumor or any other complaint requiring surgical or other means of treatment.
Arthroscopic assessment showing anything other than a degenerative tear of the medial meniscus requiring surgical intervention.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raine Sihvonen, MD	Tampere City Hospital	Study Chair
Teppo Järvinen, MD, PhD	Tampere University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki Central Hospital		Helsinki			Finland
Central Finland Hospital District

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39277028	Derived	Sillanpaa N, Iivanainen M, Turkiewicz A, Sihvonen R, Paavola M, Taimela S, Jarvinen TLN, Englund M. Effect of arthroscopic partial meniscectomy on structural degeneration of the knee - A 5-year MRI-based follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial. Osteoarthritis Cartilage. 2025 Feb;33(2):276-282. doi: 10.1016/j.joca.2024.09.003. Epub 2024 Sep 12.
32855201

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D019060	Minimally Invasive Surgical Procedures
D013514	Surgical Procedures, Operative
D019637	Orthopedic Procedures