|- candidate number||3318|
|- NTR Number||NTR1326|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-mei-2008|
|- Secondary IDs||NL21569.075.08 |
|- Public Title||Patellar denervation in total knee arthroplasty.|
|- Scientific Title||Circumpatellar electrocautery denervation in total knee arthroplasty without patellar resurfacing: a prospective randomized study with 1-year follow-up.|
|- hypothesis||The null hypothesis is that there is no difference in terms of pain and clinical outcome between total knee arthroplasty with and that without circumpatellar electrocautery denervation.|
|- Healt Condition(s) or Problem(s) studied||Electrocautery, Arthroplasty , Total knee arthroplasty, Patella, Denervation|
|- Inclusion criteria||All patients who will be treated with a total knee arthroplasty without patellar resurfacing in the Deventer hospital.|
|- Exclusion criteria||1. Isolated patellofemoral osteoarthritis. |
2. Contralateral patellar resurfacing (primary or as revision).
3. Insufficient Dutch language skills.
4. Total hip replacement or contralateral total knee replacement within the study period or less than one year before entering the study
5. Inflammatory arthritis.
6. History of patellar fracture.
7. Prior patellectomy.
8. Patellofemoral instability.
9. Prior unicondylar knee replacement.
10. Previous high tibial or distal femoral osteotomy.
11. Any prior operation involving the extensor mechanism.
12. A severe medical disability that limits the ability to walk.
13. Disabling disease involving other joints of the lower extremities.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2008|
|- planned closingdate||31-dec-2012|
|- Target number of participants||200|
|- Interventions||Circumpatellar electrocautery denervation in total knee arthroplasty without patellar resurfacing.|
|- Primary outcome||Prevalence of anterior knee pain using the Clinical Anterior Knee Pain Rating.|
|- Secondary outcome||Pain on a Visual Analogue Scale (VAS).
WOMAC 3.1 Osteoarthritis Index.
Knee Society Score.|
|- Timepoints||Preoperative, 12 months, 2 years and 4 years after total knee arthroplasty.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD Hans-Peter W. Jonbergen, van|
|- CONTACT for SCIENTIFIC QUERIES||MD Hans-Peter W. Jonbergen, van|
|- Sponsor/Initiator ||Deventer Ziekenhuis, Department of Orthopaedic Surgery|
(Source(s) of Monetary or Material Support)
|Deventer Ziekenhuis, Department of Orthopaedic Surgery|
|- Brief summary||Anterior knee pain occurs in up to 31% of patients after total knee arthroplasty without patellar resurfacing, and in approximately up to 16% of patients with patellar resurfacing. The cause of patellofemoral pain after total knee arthroplasty is unknown but may at least be partly related to postoperative malalignment and anatomic variations resulting in high patellofemoral contact forces. Immunohistochemical studies on innervation of the anterior knee have found hyperinnervation in the peripatellar soft tissues. In theory, circumpatellar denervation using electrocautery could result in a lower prevalence of anterior knee pain. To date, no relevant clinical studies addressed the results of circumpatellar electrocautery denervation in total knee arthroplasty without patellar resurfacing. Primary objective was therefore to determine the effect of circumpatellar electrocautery denervation in total knee arthroplasty without patellar resurfacing, particularly with regard to anterior knee pain.
|- Main changes (audit trail)|
|- RECORD||25-mei-2008 - 11-jan-2011|