Trial of gun application vs finger loading of cement for cementation of tibial component in primary total knee replacement
| ISRCTN | ISRCTN75253522 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75253522 |
| Protocol serial number | N0504095061 |
| Sponsor | Department of Health |
| Funder | Northumbria Healthcare NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 14/11/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr D J Kramer
Scientific
Scientific
Orthopaedic Department
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
| Phone | +44 (0)191 259 6660 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Trial of gun application vs finger loading of cement for cementation of tibial component in primary total knee replacement |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Total knee replacement (TKR) |
| Intervention | Patients undergoing total knee replacement surgery will be randomised into two groups. Group A will have their knee replacement implanted using the current technique of finger packing cement into bone for the femoral component and loading the tibial tray with cement before impaction of the tibial implant. Group B will have cement applied while still liquid to the tibial plateau using the cement gun before application of the tibial component. Other aspects of bone preparation and cementing will remain unchanged, including use of pulsed lavage and hydrogen peroxide. Initial outcome will be assessed according to radiolucent lines on post-operative radiographs. Assessments will be performed by a single observer (RKP), blinded to the patients' group allocation. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) | Long-term outcome will be assessed after 10 years prospective follow-up - revision rate |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 30/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Patients undergoing primary total knee replacement for osteoarthritis 2. Males and female inpatients |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2000 |
| Date of final enrolment | 30/05/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Orthopaedic Department
North Shields
NE29 8NH
United Kingdom
NE29 8NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
