Sub-vastus versus Medial parapatellar Arthrotomy for total Knee replacement

ISRCTN	ISRCTN44544446
DOI	https://doi.org/10.1186/ISRCTN44544446
Protocol serial number	N0158124154
Sponsor	University Hospital of North Staffordshire NHS Trust (UK)
Funder	NHS R&D Support Funding (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr David Griffiths
Scientific

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

Phone	+44 (0)1782 553102
Email	david.griffiths@uhns.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Sub-vastus versus Medial parapatellar Arthrotomy for total Knee replacement
Study acronym	SMAK
Study objectives	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(s)	Ethical approval was obtained from the local ethics committee for the trial.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Knee Society Score at 52 weeks.
Key secondary outcome measure(s)	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
Completion date	01/08/2004

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	231
Key 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
Key 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
Date of first enrolment	01/02/2001
Date of final enrolment	01/08/2004

HOSU Locomotor Directorate

Stoke-on-Trent
ST4 6QG
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		31/07/2006		Yes	No
Protocol article		31/07/2006		Yes	No

27/10/2022: Internal review.