The Adler Genus Unicompartmental Knee Prosthesis post-marketing surveillance study
| ISRCTN | ISRCTN14119313 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14119313 |
| Protocol serial number | 042C/2014/EOC/D5 |
| Sponsor | Adler Ortho srl |
| Funder | Adler Ortho srl (Italy) |
- Submission date
- 25/02/2015
- Registration date
- 11/03/2015
- Last edited
- 21/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Public
Marketing & Technology Manager
Adler Ortho SpA
Via dell’Innovazione 9
Cormano
Milan
20032
Italy
| Phone | +39 02 615437201 |
|---|---|
| cdottino@adlerortho.com |
Scientific
Marketing & Technology Manager
Adler Ortho SpA
Via dell’Innovazione 9
Cormano
Milan
20032
Italy
| Phone | +39 02 615437201 |
|---|---|
| cdottino@adlerortho.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicentre prospective clinical surveillance study |
| Secondary study design | Cohort study |
| 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. |
| Study objectives | 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(s) | NRES Committee London - Stanmore, 14/10/2014, ethics committee reference: 14/LO/1640, protocol number: 1/191113 |
| Health condition(s) or problem(s) studied | Osteoarthritis of the knee treated with knee arthroplasty (knee replacement surgery) |
| 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 | Not Applicable |
| Drug / device / biological / vaccine name(s) | Genus Unicompartmental knee prosthesis |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Patients Oxford Knee score |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 350 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 22/01/2015 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
- France
Study participating centre
Epsom
KT18 7EG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | Under the terms of their contract, the individual participant data will only be available to the healthcare professionals involved in the study and the study sponsor. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version v2 | 14/10/2014 | 28/07/2020 | No | No |
Additional files
- ISRCTN14119313_Protocol_v2_14Oct2014.pdf
- Uploaded 28/07/2020
Editorial Notes
21/08/2020: The IPD sharing statement has been added.
28/07/2020: The following changes have been made:
1. Uploaded protocol version 2 14 October 2014 (not peer-reviewed).
2. The publication and dissemination plan has been added.
3. The intention to publish date has been added.
20/07/2020: The public and scientific contacts have been changed.
23/03/2016: The public contact for the study has been changed from Mr Mahamed Elsherbiny to Mr Sas Maheswaran
