Condition category
Surgery
Date applied
21/11/2005
Date assigned
22/11/2005
Last edited
22/02/2008
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

Mr David Griffiths

ORCID ID

Contact details

HOSU Locomotor Directorate
City general UHNST
Stoke-on-Trent
ST4 6QG
United Kingdom
+44 (0)1782 553102
david.griffiths@uhns.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0158124154

Study information

Scientific title

Acronym

SMAK

Study hypothesis

In patients undergoing primary or tri-compartmental knee replacement the sub-vastus approach is significantly superior to the standard medial parapatelar approach in terms of short and long term knee function.

Ethics approval

Ethical approval was obtained from the local ethics committee for the trial.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Total knee replacement

Intervention

Standard medial parapatellar approach or sub-vastus approach for primary bi- or tri- compartmental total knee replacement.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Knee Society Score at 52 weeks.

Secondary outcome measures

1. EuroQol-5D
2. Western Ontario and McMaster Universities (WOMAC) osteoarthritis index
3. 36-item short form health survey (SF-36)
4. Time to normal activities/return to function
5. Pain
6. Complications
7. Surgeon's ease of exposure
8. Length of hospital stay

Overall trial start date

01/02/2001

Overall trial end date

01/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. They require a bi- or tri- compartmental knee replacement
2. They require a unilateral knee replacement
3. They have given their informed consent
4. The surgeon has no clear preference for either of the approaches

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

231

Participant exclusion criteria

1. They need a revision knee replacement
2. They have had, or will require a major arthrotomy in the other knee in a 12 month period
3. They have had previous open surgery in or around the knee in the previous 12 months e.g. high tibial osteotomy, femoal osteotmy, open reduction internal fixation (ORIF) for fracture, patellar realignment, patellectomy and open menisectomy
4. They require a bi-lateral knee replacement at a single visit
5. They have a valgus angle of degrees or more

Recruitment start date

01/02/2001

Recruitment end date

01/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

HOSU Locomotor Directorate
Stoke-on-Trent
ST4 6QG
United Kingdom

Sponsor information

Organisation

University Hospital of North Staffordshire NHS Trust (UK)

Sponsor details

Trust Headquarters
Princes Road
Hartshill
Stoke-on-Trent
ST4 7LN
United Kingdom
+44 (0)1782 715444
david.griffiths@uhns.nhs.uk

Sponsor type

Government

Website

http://www.uhns.nhs.uk/

Funders

Funder type

Government

Funder name

NHS R&D Support Funding (UK)

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

Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/16879741
2. http://www.ncbi.nlm.nih.gov/pubmed/16879744

Publication citations

  1. Ebinesan AD, Sarai BS, Walley G, Bridgman S, Maffulli N, Total knee arthroplasty: good agreement of clinical severity scores between patients and consultants., BMC Musculoskelet Disord, 2006, 7, 61, doi: 10.1186/1471-2474-7-61.

  2. Bridgman S, Walley G, MacKenzie G, Clement D, Griffiths D, Maffulli N, Sub-vastus approach versus the medial parapatellar approach in primary total knee: a randomised controlled trial [ISRCTN44544446]., Trials, 2006, 7, 23, doi: 10.1186/1745-6215-7-23.

Additional files

Editorial Notes