Functional outcome in two different designs of knee replacements
| ISRCTN | ISRCTN05635855 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05635855 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/05/2008
- Registration date
- 24/07/2008
- Last edited
- 09/11/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Marietta van der Linden
Scientific
Scientific
School of Health Sciences
Queen Margaret University
Queen Margaret University Drive
Musselburgh
EH21 6UU
United Kingdom
| Phone | +44 (0)131 4740000 |
|---|---|
| mvanderlinden@qmu.ac.uk |
Study information
| Study design | Prospective, double blind randomised controlled trial, single centre study |
|---|---|
| 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 | A randomised controlled trial to compare the functional outcome between the PFC Sigma fixed bearing posterior cruciate ligament (PCL) preserving implant with the PFC Sigma posterior stabilised mobile bearing implant |
| Study objectives | The aim of this study is to compare the functional outcome of the cruciate substituting PFC Sigma rotating platform flexion (RPF) implant with the cruciate retaining PFC Sigma cruciate retaining (CR) in patients with osteoarthritis. |
| Ethics approval(s) | Ethics approval received from the Lothian Research Ethics Committee 2 on the 22nd May 2007 (ref: 07/S1102/12). |
| Health condition(s) or problem(s) studied | Total knee replacement surgery |
| Intervention | Two groups of patients will be compared. The only difference in treatment between the two groups will be the use of the PFC Sigma RPF which has a mobile bearing and requires sacrificing of the posterior cruciate ligament and the posterior cruciate ligament retaining PFC Sigma implant which has a fixed bearing. Follow-up will be one year after surgery when the primary and secondary outcome measures are collected. |
| Intervention type | Other |
| Primary outcome measure | Knee excursion during functional activities as measured using electrogoniometry. Primary and secondary outcome measures are collected around one to three weeks before surgery and one year after surgery for both groups. |
| Secondary outcome measures | 1. The passive range of motion of the knee 2. Flexor and extensor strength as measured using a MIE myometer 3. Function as measured by the American Knee Society Score 4. Function, stiffness and pain as measured by the Western Ontario and McMaster Universities (WOMAC) questionnaire 5. Quality of life, using the 36-item short form health survey, version 2 (SF-36 v2) 6. Pain, using the Visual Analogue Score (0 = no pain to 10 = unbearable pain) 7. Walking speed 8. Physical mobility as measured by an activity monitor (activPAL) 9. Canadian Occupational Performance Measure Primary and secondary outcome measures are collected around one to three weeks before surgery and one year after surgery for both groups. |
| Overall study start date | 01/09/2007 |
| Completion date | 01/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | Ninety suitable men and women (no age limits) with osteoarthritis undergoing a Total Knee Replacement (TKR) at the New Royal Infirmary, Edinburgh who are able to actively flex the knee more than 90 degrees will be recruited from the waiting list of three orthopaedic surgeons. Suitable patients will be identified from medical records and will be living in the Lothian region. All subjects will be medically fit for testing and have no other lower limb impairments. |
| Key exclusion criteria | 1. Inflammatory polyarthritis 2. Disorders of the feet, ankles or hips or spine causing abnormal gait or significant pain 3. Dementia 4. Severe visual impairment 5. Neurological conditions affecting movement 6. Inability to give informed consent 7. Any other disorders of the contra-lateral knee causing abnormal gait or significant pain. Subjects with radiological evidence of osteoarthritis of the contra-lateral knee will be included provided the patient does not report significant pain or restriction in motion of the contra-lateral knee. Similarly patients with total knee arthroplasty of the contra-lateral knee will be included provided the patient does not report significant pain or restriction in motion of the contra-lateral knee. |
| Date of first enrolment | 01/09/2007 |
| Date of final enrolment | 01/09/2009 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
School of Health Sciences
Musselburgh
EH21 6UU
United Kingdom
EH21 6UU
United Kingdom
Sponsor information
Queen Margaret University (UK)
University/education
University/education
c/o Professor Marie Donaghy
School of Health Sciences
Queen Margaret University Drive
Musselburgh
EH21 6UU
Scotland
United Kingdom
| Website | http://www.qmu.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/002g3cb31 |
Funders
Funder type
Industry
DePuy International Ltd (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2012 | Yes | No |
