Condition category
Musculoskeletal Diseases
Date applied
25/02/2015
Date assigned
11/03/2015
Last edited
23/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Knee replacement surgery (arthroplasty) involves replacing a damaged, worn or diseased knee with an artificial joint (knee prosthesis). It is a routine operation for knee pain most commonly caused by arthritis. The aim of this study is to test the safety and effectiveness of the Genus Unicompartmental knee prosthesis over a period of 10 years.

Who can participate?
Patients aged 18-80 undergoing knee arthroplasty for osteoarthritis.

What does the study involve?
Participants will undergo knee replacement surgery using the Genus Unicompartmental knee prosthesis. They will be required to fill in yearly questionnaires concerning their knee and general wellbeing. They will also be required to attend clinical assessments after 1, 3, 5, 7 and 10 years, where a clinical assessment of the knee will be performed and an x-ray will be taken.

What are the possible benefits and risks of participating?
Possible benefits include prolonged clinical follow-up to assess the outcome of the operation over 10 years. Possible risks include exposure to additional radiation that is not part of normal practice; however, this has been assessed by a radiology expert and deemed to be of minimal risk.

Where is the study run from?
The Elective Orthopaedic Centre (EOC), in Epsom, Surrey, will be the study coordinating centre. Six further centres will participate in the clinical study.

When is the study starting and how long is it expected to run for?
From June 2014 to December 2027.

Who is funding the study?
Adler Ortho srl (Italy).

Who is the main contact?
Mohamed Elsherbiny (Mohamed.Elsherbiny@eoc.nhs.uk)
Mark Rickman

Trial website

Contact information

Type

Public

Primary contact

Mr Sas Maheswaran

ORCID ID

Contact details

The Elective Orthopaedic Centre
Dorking Road
Epsom
KT18 7EG
United Kingdom
+44 1372 735 424
Sas.Maheswaran@eoc.nhs.uk

Type

Scientific

Additional contact

Mr Mark Rickman

ORCID ID

Contact details

The Elective Orthopaedic Centre
Dorking Road
Epsom
KT18 7EG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

042C/2014/EOC/D5

Study information

Scientific title

The clinical perfomances of the Genus Unicompartmental Knee Prosthesis manufactured by Adler Ortho srl will be evaluated by a multicentre prospective clinical surveillance study.

Acronym

Study hypothesis

New Orthopaedic Implants introduced in the market should be followed in order to check their safety and efficacy. The aim of this study would be to assess safety (as defined by NICE and ODEP rating guidelines) and clinical performances of the Genus Unicompartmental knee over 10 years time on a cohort of 350 patients.

The Elective Orthopaedic Centre (EOC), in Epsom, Surrey, will be the study coordinating centre. Six further centres will participate in the clinical study, for seven total centres. Each participating centre will recruit approximately 50 patients. Patient recruitment will cease when a cohort of 350 Genus Unicompartmental knee prosthesis have been implanted.

Ethics approval

NRES Committee London - Stanmore, 14/10/2014, ethics committee reference: 14/LO/1640, protocol number: 1/191113

Study design

Multicentre prospective clinical surveillance study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Unicompartmental knee arthrosis, and not otherwise treatable cartilage defects of the knee localized in one joint compartment.

Intervention

Each patient will be submitted to the following set of investigation tools:
Pre-op: patient’s demographic and radiological review; baseline questionnaire - EuroQol, Oxford Knee and Knee Society scores.
Peri-op: operation details including peri-operative and early post-operative complications (complications that occur before patient discharge).
Post-op: Clinical Knee Society Score and radiological review at 1, 3, 5, 7 and 10 years and postal Oxford Knee and EuroQol scores annually.

X-rays will be checked looking for prosthesis alignment and any sign of loosening or wear.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Implant survival rate keeping revision for any reason of any prosthetic component as an end point. Implant survival rate will be elaborated employing the Kapan-Meier statistical system.

Secondary outcome measures

1. Patients Oxford Knee score
2. Knee Society Score
3. EuroQol score
PROMs are being collected pre-op, 3 months, 6 months and annually after that. For clinical assessment it will be done at 1, 3, 5, 7 and 10 years post-operatively

Overall trial start date

01/06/2014

Overall trial end date

31/12/2027

Reason abandoned

Eligibility

Participant inclusion criteria

1. A primary osteoarthritis of one compartment (medial or lateral)
2. Patients must be between the age of 18 and 80 at the time of consent
3. Listed for unicompartmental knee arthroplasty
4. Patients who are willing to give informed written consent
5. Absence of any degenerative disease of a progressive nature (e.g. rheumatoid arthritis)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

350 patients in total will be enrolled in the study. 7 centres will be in total involved, performing at least 50 implants each

Participant exclusion criteria

1. Progressive local or systemic infection
2. Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable
3. Severe instability secondary to advanced destruction of chondral structures or loss of integrity of the medial, lateral or either cruciate ligament
4. Any patient who cannot or will not provide informed consent for participation in the study
5. Those whose prospects for a recovery to independent mobility would be compromised by known coexistent medical problems
6. Patient whose BMI exceeds 45
7. Any case not described in the inclusion criteria

Recruitment start date

22/01/2015

Recruitment end date

31/12/2017

Locations

Countries of recruitment

France, United Kingdom

Trial participating centre

The Elective Orthopaedic Centre
Dorking Road
Epsom
KT18 7EG
United Kingdom

Sponsor information

Organisation

Adler Ortho srl

Sponsor details

via dell'innovazione 9
Cormano
20032
Italy
+39 (0)2 615437221
cdottino@adlerortho.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Adler Ortho srl (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

23/03/2016: The public contact for the study has been changed from Mr Mahamed Elsherbiny to Mr Sas Maheswaran