NCT01747681

Brief Summary

Articular cartilage lesions are commonly occurring. In a prospective study of 1,000 knee arthroscopies focal chondral or osteochondral defects were found in 19% of the patients (Hjelle 2002). Chronic articular cartilage defects do not heal spontaneously. However, acute traumatic osteochondral lesions or surgically inflicted lesions extending into subchondral bone, e.g. by drilling (Pridie 1959), spongialization, abrasion or microfracture with an angled awl (Rodrigo 1994) causing the release of pluripotent mesenchymal stem cells from the bone marrow, may heal with repair tissue consisting of fibrous tissue, fibrocartilage or hyaline-like cartilage. The microfracture technique causes little damage to the subchondral bone plate and the risk of heat necroses caused by drilling or abrasion is eliminated. The quality of the repair tissue after these bone marrow stimulating techniques depends on various factors including the species and age of the individual, the size and localization of the defect, the surgical technique, e.g., how the subchondral bone plate is treated, and the postoperative rehabilitation protocol. Microfracture has been used in small traumatic defects in young sporting individuals (Steadman 2003) as well as in larger osteoarthritic lesions in older patients (Miller 2004, Steadman 2007). The purpose of the present study was to investigate the long-term clinical outcome 10 to 14 years after microfracture of articular cartilage defects in the knee and possible predictors of good and poor outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

December 10, 2012

Last Update Submit

January 26, 2015

Conditions

Keywords

chondral defectmicrofracturearthroscopycartilage repairoutcome studyLysholm score

Outcome Measures

Primary Outcomes (1)

  • Lysholm knee score

    All patients operated with a microfracture chondroplasty in the knee in 1999-2002 are invited to complete a patient-administered Lysholm score form

    10 to 14 years after surgery (in 2012-2013)

Study Arms (1)

Microfracture

Microfracture of articular chondral defect

Procedure: Microfracture

Interventions

MicrofracturePROCEDURE
Microfracture

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients operated with a microfracture of articular chondral defects in the knee at the Deaconess University Hospital from 1999 to 2002.

You may qualify if:

  • Patients with symptomatic focal full-thickness chondral lesions verified by arthroscopic examination and a minimum of 10-year follow-up.

You may not qualify if:

  • axial malpositioning,
  • ligament instabilities or inability to follow the rehabilitation protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deaconess University Hospital, Haraldsplass

Bergen, Hordaland, 5009, Norway

Location

Related Publications (1)

  • Solheim E, Hegna J, Inderhaug E, Oyen J, Harlem T, Strand T. Results at 10-14 years after microfracture treatment of articular cartilage defects in the knee. Knee Surg Sports Traumatol Arthrosc. 2016 May;24(5):1587-93. doi: 10.1007/s00167-014-3443-1. Epub 2014 Nov 23.

MeSH Terms

Conditions

Fractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Eirik Eirik, MD, PhD

    Professor

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2012

First Posted

December 12, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations