NCT00885729

Brief Summary

The purpose of this study is to:

  • Compare the treatment efficacy of autologous mesenchymal stem cells (Mesenchymal Stem Cells) versus chondrocytes implanted in a commercial available scaffold in a human clinical trial.
  • Determine the effects of specific three months strength training program preoperatively to improve knee function and possible postpone the need of cartilage repair surgery.
  • Determine if degenerative changes occur in the knee joints following cartilage repair. This question will be investigated in the proposed clinical trial.
  • Determine the characteristics of patients treated either by surgery or by rehabilitation in a long-term follow-up (1, 5 years).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

2.2 years

First QC Date

April 17, 2009

Last Update Submit

October 14, 2015

Conditions

Defect of Articular Cartilage

Keywords

Cartilage defectchondrocytesmesenchymal stem cells (MSC)femoral condyleknee

Outcome Measures

Primary Outcomes (1)

  • Lysholm score

    2018

Secondary Outcomes (1)

  • Radiographics

    Two and five years

Other Outcomes (1)

  • Return to work

    1 Year

Study Arms (2)

Stem cells

EXPERIMENTAL

Cartilage defect are treated surgical either with chondrocytes or stem cells

Procedure: stem cellsProcedure: Chondrocytes

Rehabilitation

ACTIVE COMPARATOR

Active rehabilitation program

Other: Rehabilitation program

Interventions

stem cellsPROCEDURE

Stem cells or chondrocytes under a commercial available membrane

Stem cells
ChondrocytesPROCEDURE

Implantation of chondrocytes

Stem cells
Rehabilitation programOTHER

Strength exercises, neuromuscular exercises

Rehabilitation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Norwegian citizens
  • A full-thickness cartilage lesion (diameter \> 15 mm, but less than 6 cm2 and Lysholm score \< 75 points) located on the femoral condyle

You may not qualify if:

  • Patients with malignment of the knee
  • Other knee pathology such as ACL injury or a nontreated meniscus injury will not be included in the study to avoid the impact of these knee pathologies on the final results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo UniversityHospital-Ullevaal

Oslo, Oslo County, 0481, Norway

Location

Related Publications (3)

  • Aroen A, Brogger H, Rotterud JH, Sivertsen EA, Engebretsen L, Risberg MA. Evaluation of focal cartilage lesions of the knee using MRI T2 mapping and delayed Gadolinium Enhanced MRI of Cartilage (dGEMRIC). BMC Musculoskelet Disord. 2016 Feb 11;17:73. doi: 10.1186/s12891-016-0941-y.

    PMID: 26868015DERIVED

  • Rotterud JH, Reinholt FP, Beckstrom KJ, Risberg MA, Aroen A. Relationship between CTX-II and patient characteristics, patient-reported outcome, muscle strength, and rehabilitation in patients with a focal cartilage lesion of the knee: a prospective exploratory cohort study of 48 patients. BMC Musculoskelet Disord. 2014 Mar 24;15:99. doi: 10.1186/1471-2474-15-99.

    PMID: 24661577DERIVED

  • Wondrasch B, Aroen A, Rotterud JH, Hoysveen T, Bolstad K, Risberg MA. The feasibility of a 3-month active rehabilitation program for patients with knee full-thickness articular cartilage lesions: the Oslo Cartilage Active Rehabilitation and Education Study. J Orthop Sports Phys Ther. 2013 May;43(5):310-24. doi: 10.2519/jospt.2013.4354. Epub 2013 Mar 13.

    PMID: 23485794DERIVED

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lars Engebretsen, MD,PhD

    Professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 17, 2009

First Posted

April 22, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2018

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations

NO(1)