Functional outcome of the P.F.C. Sigma® RP-F knee system and the P.F.C. Sigma® knee system
| ISRCTN | ISRCTN64287972 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64287972 |
| Secondary identifying numbers | MTO 001 |
- Submission date
- 24/07/2007
- Registration date
- 12/09/2007
- Last edited
- 13/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Knee osteoarthritis is a condition where the cartilage inside the knee joint is worn away, leading to the bones rubbing against each other and becoming damaged. In knee replacement surgery, the damaged knee joint is removed and replaced with an implant. Different knee implants are available. The aim of this study is to find out whether the P.F.C.®Sigma RP-F knee system provides patients with a higher range of motion than the P.F.C.®Sigma knee system.
Who can participate?
Patients aged 18 and over with knee osteoarthritis who require knee replacement surgery
What does the study involve?
Participants are randomly allocated to undergo knee replacement surgery with either a P.F.C. Sigma® RP-F or a P.F.C. Sigma® knee system. Range of motion is measured at 12 months.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
James Cook University Hospital (UK)
When is the study starting and how long is it expected to run for?
March 2008 to March 2019
Who is funding the study?
South Tees Hospitals NHS Trust (UK)
Who is the main contact?
Mr Anthony Hui
Contact information
Scientific
James Cook University Hospital
Division of Trauma
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Study information
| Study design | Prospective randomised controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Functional outcome of the P.F.C. Sigma® RP-F knee system and the P.F.C. Sigma® knee system: a prospective, randomised controlled trial |
| Study acronym | RP-F trial |
| Study objectives | The primary objective of this clinical trial is to test the hypothesis that the P.F.C.®Sigma RP-F knee system can deliver a higher post-operative Range Of Motion (ROM) than the P.F.C.®Sigma knee system. |
| Ethics approval(s) | County Durham & Tees Valley 1 Research Ethics Committee, 30/08/2007, ref: 07/H0905/67 |
| Health condition(s) or problem(s) studied | Osteoarthritis of the knee |
| Intervention | Eligible subjects will be randomised to primary total knee replacement with a P.F.C. Sigma® RP-F or a P.F.C. Sigma® knee system. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Measurement of the difference in the mean ROM between participants receiving a primary total knee replacement with either the P.F.C. Sigma® RP-F or the P.F.C. Sigma® knee system at 12 months. |
| Secondary outcome measures | Comparative evaluation of any post-operative variation between participants receiving a primary total knee replacement with either the P.F.C. Sigma® RP-F or the P.F.C. Sigma® knee system in change from baseline at each post operative time point (3, 12, 60 and 120 months) in terms of: 1. Functional recovery using the Oxford Knee Score 2. Quality of life assessed by the Short Form-12 (SF-12v2) questionnaire 3. American Knee Society Score 4. Survivorship analysis of the two groups at 60 and 120 months post-operatively |
| Overall study start date | 01/03/2008 |
| Completion date | 31/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 84 participants |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Male or female subjects, aged 18 years and older. 2. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. 3. Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. 4. Subjects who present with idiopathic or posttraumatic osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty and who are considered suitable for treatment with P.F.C. Sigma® RP-F and P.F.C. Sigma® knee systems. 5. Subjects, who in the opinion of the Clinical Investigator, are considered to be suitable for treatment with both investigational devices, according to the indications specified in the package insert leaflet. |
| Key exclusion criteria | 1. Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study. 2. Subjects with a Body Mass Index (BMI) >35. 3. Subjects with a known history of poor compliance to medical treatment. 4. Women who are pregnant. 5. Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. 6. Subjects involved in Medical-Legal claims. 7. Intra-operative use of augmentation devices. 8. Intra-operative decision to resurface the patella based on clinical indication. 9. Revision of an existing knee implant. |
| Date of first enrolment | 01/03/2008 |
| Date of final enrolment | 31/03/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
TS4 3BW
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Prof. Paul Gregg
James Cook University Hospital
Division of Trauma
Marton Road
Middlesbrough
TS4 3BW
England
United Kingdom
"ROR" |
https://ror.org/02js17r36 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/03/2010 | 13/04/2022 | Yes | No |
Editorial Notes
13/04/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
18/03/2016: Plain English summary added.
Please note that this trial actually started on 01/03/2008. The previous overall trial start date was 01/09/2007.
