Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
03/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof James Richardson

ORCID ID

Contact details

Institute of Orthopaedics
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Oswestry
SY10 7AG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0196127381

Study information

Scientific title

Autologous chondrocyte implantation (ACI) in the treatment of early Osteoarthritis (OA)

Acronym

Study hypothesis

PRCT of ACI with osteotomy vs osteotomy alone.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Musculoskeletal Diseases: Osteoarthritis (OA)

Intervention

ACI and osteotomy vs osteotomy alone

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Knee function
2. Quality of life indicators

Secondary outcome measures

Not provided at time of registration

Overall trial start date

02/09/2003

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Symptomatic bone on bone cartilage defects

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

Inflammatory arthritis

Recruitment start date

02/09/2003

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Oswestry
SY10 7AG
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

03/11/2015: no publications found on PubMed.