Condition category
Musculoskeletal Diseases
Date applied
04/10/2020
Date assigned
06/10/2020
Last edited
06/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Total knee replacement (arthroplasty) is usually a successful procedure with excellent outcomes although 15% of patients report they are dissatisfied. Design differences between replacement knee parts (prostheses) continue to be developed in an effort to improve these outcomes. The aim of this study is to evaluate the effect of these new design features on the outcomes following total knee arthroplasty.

Who can participate?
Patients aged 22 to 90 years old, with osteoarthritis of the knee requiring replacement

What does the study involve?
Participants will be randomly allocated to undergo a total knee replacement with either the DePuy Synthes ATTUNETM or the DePuy Synthes PFC SigmaTM cruciate-retaining systems. Patients will be followed up for 1 year.

What are the possible benefits and risks of participating?
The possible benefits include active participation in a trial to improve patient outcomes, and playing an important part in improving patient outcomes whilst not compromising their own outcome.
The new implant may not necessarily improve outcomes, but there are several studies highlighting that the newer implant has at least equivalent outcomes and is not inferior which maintains patient safety. The longer-term outcomes are yet unknown - i.e. the longevity of implant, and the need for revision at an earlier stage.

Where is the study run from?
Wrightington Hospital (UK)

When is the study starting and how long is it expected to run for?
May 2014 to August 2017

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Sunil Panchani
sunil.panchani@wwl.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Sunil Panchani

ORCID ID

https://orcid.org/0000-0001-7297-9412

Contact details

Wrightington Hospital
Wigan
WN6 9EP
United Kingdom
+44 (0)1257 258251
sunil.panchani@wwl.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 160047

Study information

Scientific title

Early functional outcomes after evolutionary total knee arthroplasty: a randomized controlled trial

Acronym

Study hypothesis

This study investigates whether or not there is a difference between the PFC or the Attune Total Knee replacement systems in terms of functional and clinical outcomes.

Ethics approval

Approved 10/11/2014, NRES Committee North West - Greater Manchester South (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8063; gmsouth.rec@hra.nhs.uk), REC ref: 14/NW/1330

Study design

Single (patient) blinded single centre randomized 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 to request a patient information sheet

Condition

Osteoarthritis of knee

Intervention

The study is designed as a single-blinded randomized controlled trial with patients blinded to their treatment arm. Subjects will remain blinded as to their treatment arm for the duration of the trial period which will be 1 year for each subject. The patient population will comprise patients being referred to or currently under review for symptomatic knee osteoarthritis at Wrightington Hospital, United Kingdom.

Patients will be primarily recruited and consented during the clinic consultation. Enrolment and consent to the trial will only be performed by researchers with Good Clinical Practice (GCP) certification. Consent forms and patient information sheets have been devised using departmental guidance and protocols.

Procedure
Patients undergo a total knee replacement with either the DePuy Synthes ATTUNETM or the DePuy Synthes PFC SigmaTM cruciate-retaining system

Data collection
Both demographic and clinical data will be recorded throughout the trial period. Demographic data will include age, sex, height, weight, body mass index as well as co-morbidities. Clinical data will include implant sizes, wound closure methods, tourniquet time, ASA grade, Hospital Length of Stay, Pre and post-operative Haemoglobin and complications including but not limited to infection, deep vein thrombosis and further surgery to the operated or non operated limb within the trial period for any reason will be recorded.

Clinical and Functional Outcome measures
The outcomes of interest comprise general and disease-specific patient-reported outcome measures (PROMs). Disease-specific scores include the Oxford Knee Score (OKS)7, the Oxford Knee Score Activity and Participation Questionnaire (OKS-APQ)8 and the Patient Knee Implant Performance score (PKIP)9. The SF-3610 and EQ5D – 5L11 will also be completed as generic health measures.
The pre- and post-operative range of movement (ROM) as measured with a goniometer will also be assessed together with Visual Analogue Pain Scores (VAS).

Trial packs comprising a pre-operative pack, a 6-week post-operative pack, a 12-week post-operative pack and a 52-week post-operative pack will be devised comprising the relevant outcome measures to allow ease of completion for the subjects.

Randomization
Patients will be randomized using sealed envelopes based on lists prepared in advance of the first patient being randomised. Randomisation lists shall be produced by the trial statistician via randomly permuted blocks using the 'ralloc’ command within the statistical package Stata R. No stratification factors are to be included in the study.

The primary endpoint is the difference between pre-surgery and 6 weeks, 3 months and 1-year measurements of the Oxford Knee Score.

Intervention type

Device

Phase

Not Applicable

Drug names

PFC and ATTUNE Total Knee Replacement systems - DePuy Synthes

Primary outcome measure

Knee function measured using the Oxford Knee Score at baseline, 6 weeks, 3 months and 1 year

Secondary outcome measures

1. Knee function measured using the OKS-APQ Questionnaire at baseline, 6 weeks, 3 months and 1 year
2. Knee function measured using the PKIP Questionnaire at baseline, 6 weeks, 3 months and 1 year
3. General health measured using the SF-36 Questionnaire at baseline and 1 year
4. Quality of life measured using the EQ5D-5L Questionnaire at baseline, 6 weeks, 3 months and 1 year
5. Pain measured using VAS Questionnaire at baseline, 6 weeks, 3 months and 1 year
6. Range of movement measured using a Goniometer at baseline, 6 weeks, 3 months and 1 year

Overall trial start date

01/05/2014

Overall trial end date

01/08/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 22 to 90 years old inclusive
2. A diagnosis of non-inflammatory osteoarthritis of the knee
3. Primary varus osteoarthritic deformity
4. Stable collateral ligaments at the time of pre-operative clinical examination
5. Patient is a candidate for routine primary knee arthroplasty (cruciate retaining) in line with manufacturer guidelines
6. Subject is able to give consent to the procedure

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Total final enrolment

150

Participant exclusion criteria

1. A patient with a diagnosis of inflammatory osteoarthritis
2. Severe bone defects or deformity which will require augmentation with bone graft or augmented prosthesis or a constrained device
3. Valgus osteoarthritis
4. Previous patellectomy
5. Patient has a contralateral TKR which is a PFCTM or ATTUNETM implant
6. Patient has a poorly functioning or symptomatic contra-or ipsilateral total hip replacement
7. Previous lower limb amputation on either limb
8. Previous fractures, osteotomy or surgery to the knee which required metal implantation and/or ligament reconstruction
9. Neurogenic cause for arthritis in the knee or associated neurological symptoms in lower limb referred from spine

Recruitment start date

01/12/2014

Recruitment end date

01/08/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wrightington Hospital
Appley Bridge Hall Lane
Wigan
WN6 9EP
United Kingdom

Sponsor information

Organisation

Wrightington Hospital

Sponsor details

Hall Lane
Wigan
WN6 9EP
United Kingdom
+44 (0)1942 244 000
Tim.Board@wwl.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.wwl.nhs.uk/hospitals/wrightington/default.aspx

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal
JBJS - article
BOA, BASK - International Presentations

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. The data is stored in a secure password-protected file on a Hospital secured drive and only the research team have access to this.

Intention to publish date

01/04/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

2015 protocol in https://doi.org/10.15761/CRT.1000113 (added 06/10/2020)

Publication citations

Additional files

Editorial Notes

06/10/2020: Trial's existence confirmed by NRES Committee North West - Greater Manchester South.