|- candidate number||17680|
|- NTR Number||NTR4579|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-mei-2014|
|- Secondary IDs||14-N-52 |
|- Public Title||Day Care Surgery for Unicompartmental Knee Arhtroplasty
|- Scientific Title||Pathway Controlled Day Care Surgery for Unicompartmental Knee Arhtroplasty
Preliminary Results from a Teaching Hospital in the Netherlands
|- ACRONYM||UKA, uni knee arthroplasty|
|- hypothesis||We hypothesize that there is no difference between the Day Care surgery pathway compared to the Rapid Recovery pathway in patients operated for unicompartmental knee arthroplasty (UKA).|
|- Healt Condition(s) or Problem(s) studied||Knee, Arthroplasty |
|- Inclusion criteria||Completed the full follow up (1Y) |
Patient who followed the Day Care Surgery- or the Rapid Recovery pathway
|- Exclusion criteria||Patients who did not complete the full follow up (1Y)|
Patient did not follow the Day Care Surgery- or the Rapid Recovery pathway
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jun-2014|
|- planned closingdate||1-jan-2015|
|- Target number of participants||40|
|- Interventions||As part of the pathway, 6 weeks before surgery patients visit the “Joint school” to get familiar with the postoperative exercises, the training program and walking (stairs) with crutches under the supervision of a physiotherapist.
Indication for surgery, are as generally accepted for UKA. Patients are operated with the use of patients specific pin guides (PSG; Signature, Biomet, Warsaw INC) without tourniquete and received the uncemented Oxford partial knee implant (Biomet, Warsaw INC). Intra operatively, a long acting analgesia (150ml Ropivacaine (2mg/ml)) is injected as described by the protocol of Kehlet and Andersen for early postoperative pain relief before insertion of the prosthesis.  First posterior (50ml) and anterior (50ml) joint capsule are injected. After prosthesis is placed the subcutis is infiltrated (50ml). No drains and catheters are used. Urine retention is tested with the use of a bladder scan.
Within 6 hours of infusion of spinal anesthesia the patient starts to mobilize under the supervision of a physiotherapist. Daily exercises are executed individualy. Patients are discharged if following criteria are achieved: safe mobilization, transfers and able to walk stairs with crutches if necessary and a knee flexion of >70° .
|- Primary outcome||Safety|
Complications and readmissions are recorded in the patients record. Complications are classified as surgical related (infection), patient related (trombo embolic complication and wound problems) or prosthesis related (loosening).
|- Secondary outcome||Efficacy |
Pain is measured using a visual analog scale (VAS; 0 to 100, 100 being most pain). VAS is obtained before and after the first mobilization. Post operative nausea and vomiting are recorded (PONV) in the patients clinical report. VAS pain score and PONV are measured direct post operatively and 3 times daily at 8:00, 16:00 and 22:00 hours over the first 48 hours post operatively using pain and PONV diaries for each patient.
Early mobilization will be evaluated. Exercises started within six hours post operative. Under supervision of a physiotherapist, individual physiotherapy is appplied.
Length of hospital stay (in minutes and days) is registered. All patients are familiar with the discharge criteria. If these criteria are achieved, they were discharged. Discharge criteria are examined by the ward doctor. During the practice sessions each patient is evaluated if the discharge criteria were achieved. If there is any deterioration or a lack of progress in the function occurs, the ward doctor or operating surgeon is consulted. Before discharge from the hospital, all patients received instructions for wound care and self learning administering syringes against thrombosis. All patients are discharged to their home environment.
During the full follow up patients had to fill in 3 different questionnaires;
The Western Ontario And McMaster Universities Arthritis Index (WOMAC) 0 to 100, 100 being the best outcome
Pain Visual Analogue Scale (Pain VAS) 0 to 10, 10 being most pain
The Oxford Knee Score (OHS)0 to 48, 48 being the best outcome
|- Timepoints||Pre-, per- 3 months and 1 year post operative|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. M.G.M. Schotanus|
|- CONTACT for SCIENTIFIC QUERIES||Drs. M.G.M. Schotanus|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|- Publications||Nanne P. Kort, Yoeri F.L. Bemelmans, Martijn G.M. Schotanus.Outpatient surgery for unicompartmental knee arthroplasty is effective and safe. Knee Surg Sports Traumatol Arthrosc DOI 10.1007/s00167-015-3680-y\|
|- Brief summary||There has been increasing interest in accelerated programs for day care surgery within unicompartmental knee arthroplasty (UKA) in Europe. We examined the feasibility of a elective day care surgery pathway in patients undergoing UKA.|
|- Main changes (audit trail)|
|- RECORD||6-mei-2014 - 27-jul-2015|