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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01747681
Other study ID # 2012-Microfracture
Secondary ID
Status Completed
Phase N/A
First received December 10, 2012
Last updated January 26, 2015
Start date December 2012
Est. completion date February 2014

Study information

Verified date January 2015
Source Bergen Orthopedic Study Group
Contact n/a
Is FDA regulated No
Health authority Norway: Data Protection AuthorityNorway: Regional Ethics Commitee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date February 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Procedure:
Microfracture


Locations

Country Name City State
Norway Deaconess University Hospital, Haraldsplass Bergen Hordaland

Sponsors (1)

Lead Sponsor Collaborator
Bergen Orthopedic Study Group

Country where clinical trial is conducted

Norway, 

References & 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. 2014 Nov 23. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No