Results at 10 to 14 Years After Microfracture in the Knee

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Bergen Orthopedic Study Group
Sponsor:
Information provided by (Responsible Party):
Bergen Orthopedic Study Group
ClinicalTrials.gov Identifier:
NCT01747681
First received: December 10, 2012
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Articular Chondral Defect
Procedure: Microfracture

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Results at 10 to 14 Years After Microfracture in Articular Cartilage Defects in the Knee

Further study details as provided by Bergen Orthopedic Study Group:

Primary Outcome Measures:
  • Lysholm knee score [ Time Frame: 10 to 14 years after surgery (in 2012-2013) ] [ Designated as safety issue: No ]
    All patients operated with a microfracture chondroplasty in the knee in 1999-2002 are invited to complete a patient-administered Lysholm score form


Estimated Enrollment: 110
Study Start Date: December 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Microfracture
Microfracture of articular chondral defect
Procedure: Microfracture

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Exclusion criteria were joint space narrowing (< 4 mm) on standard antero-posterior x-ray films,
  • axial malpositioning,
  • ligament instabilities or inability to follow the rehabilitation protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747681

Contacts
Contact: Eirik J Solheim, MD, PhD +47-92220318 eirik.solheim@uib.no
Contact: Janne E Hegna, MM +47-90558699 janne.hegna@dagkirurgi.no

Locations
Norway
Deaconess University Hospital, Haraldsplass Recruiting
Bergen, Hordaland, Norway, 5009
Principal Investigator: Eirik J Solheim, MD, PhD         
Sponsors and Collaborators
Bergen Orthopedic Study Group
  More Information

No publications provided

Responsible Party: Bergen Orthopedic Study Group
ClinicalTrials.gov Identifier: NCT01747681     History of Changes
Other Study ID Numbers: 2012-Microfracture
Study First Received: December 10, 2012
Last Updated: December 11, 2012
Health Authority: Norway: Data Protection Authority
Norway: Regional Ethics Commitee

Keywords provided by Bergen Orthopedic Study Group:
chondral defect
microfracture
arthroscopy
cartilage repair
outcome study
Lysholm score

ClinicalTrials.gov processed this record on July 29, 2014