|- candidate number||10621|
|- NTR Number||NTR3191|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-dec-2011|
|- Secondary IDs||11N105 METC Orbis|
|- Public Title||Rapid Recovery in patients undergoing total knee arthroplasty, first better than faster!|
|- Scientific Title||Multidisciplinair approach in total knee arthroplasty combined with Patient specific instruments.|
Implementation of Rapid Recovery in a Dutch Hospital.
|- hypothesis||Increased patient satisfaction, earlier mobilization with better a pain control.|
|- Healt Condition(s) or Problem(s) studied||Total knee arthroplasty, Rehabilitation, Local Infiltration Anasthesia (LIA), Rapid Recovery, Early mobilisation|
|- Inclusion criteria||100 consecutive patients who are diagnosed with osteoarthritis and will be initiated for total knee arthroplasty (TKA) will be enrolled in this pilot study. All patients will be operated by one surgeon.|
|- Exclusion criteria||There is no exclusion criteria. Due to the introduction of the Rapid Recovery Program, all consecutive patients who are initiated for a knee replacement surgery, will participate in a Rapid Recovery program or the Joint Care program. All patients who undergo surgery in the morning will participate in the Rapid Recovery group and all patients who undergo surgery in the afternoon will participate in the the Joint Care Group.|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||5-dec-2011|
|- planned closingdate||1-okt-2012|
|- Target number of participants||100|
|- Interventions||Due to the introduction of the Rapid Recovery program in December 2011 all patients who will be operated for a knee Replacement surgery will participate in the Rapid Recovery program or in the Joint Care Program.
The Rapid Recovery Programme has been designed to optimise all aspects of a patient's journey from pre-operative assessment through to and beyond discharge.
Through the programme the average hospital stay is reduced, but every patient is different. The programme promotes a rapid recovery but patients never leave hospital until they are ready.
Patients attend a 'Joint School' at the hospital prior to their admission. They will be invited to bring a relative or friend to act as a 'coach' and support them. Information on all aspects of having a joint replacement are provided. Patients meet all the team members that will be involved in their care from the Pre-Assesment Nurse, to the Surgeon, Physiotherapist and Pharmacist. This really helps to take away the fear and worry that having surgery can bring. Patients are encouraged to take responsibility for their recovery and a pro-active approach is encouraged.
After the operation the programme focuses on getting patients out of bed and starting to move their joint as soon as possible with the support of good pain management. This results in patients making a quicker recovery than average and being able to return to active life as soon as possible.
The goal of Rapid Recovery is to mobilize the patient as soon as possible and
Daily activities can resume safely. Patient's will achieve bappropriate pain relief medication and individualized rehabilitation program. Reduced hospital stays improve patient satisfaction and aiming for a timely discharge promotes excellent team communication for professionals.
During the implementation we want to observe as much as possible.
All patients operated in the morning will participate in the Rapid Recovery Group
(Intervention, n = 50) and all patients operated in the afternoon will rehablitate in the Joint Care group Control,N= 50).
The split between morning and afternoon is due to the local infitrate anesthesia applied in Rapid Recovery program so that mobilization can occur earlier. Timeline inlcusie will be + / - 8 months.
What is the added value compared to Rapid Recovery Joint Care?
The rehabilitation Rapid Recovery has a number of changes compared to Joint Care, the total rehabilitation process will probably be shortened.
1. The analgesic protocol has been improved. The patient receives more painkillers in tablet form offered both before and after operation, reducing morphine pain killers needed. This ensures that the patient to be affected by less nausea after surgery. In addition, painkillers during surgery injected into the tissues surrounding the 'new knee'. This makes the patient more capable after surgery to mobilize;
2. Instead of standard Rehabilitation following, the patient has a personal rehabilitation program;
3. If the patient meets the discharge criteria, the patient can be discharge from the hospital.
The patient will be discharged to home or to the rehabilitation center if it meets the following discharge criteria:
1. Independent in and out of bed;
2. Independent in and out of a chair;
3. Safe walking with tool;
4. If applicable, walking stairs;
5. Sufficient knee function.
Important for the patient to know that we do not stick to a standard number of days in hospital. Where to aptient satisfies all the above points, it is safe to the hospital to leave. During the follow-up appointments (after 6 weeks, 3 months and 1 year after surgery), we will evaluate how the patient rehabilitation program progresses.
|- Primary outcome||1. Nausea- and Pain score due Visual analog scale (VAS) at scheduled times after surgery until discharge;|
2. Date of discharge from hospital.
|- Secondary outcome||6 weeks after surgery the patient have to fill in a questinonnaire about Patient satisfaction.
Because of the multidisciplinair aproach we will take a survey in the beginning and at the end of the pilot study off all participating specialty who were involved during the implemnetation of Rapid Recovery.
|- Timepoints||10 months after the first operation.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| P.C. Mathijssen|
|- CONTACT for SCIENTIFIC QUERIES||Drs. M.G.M. Schotanus|
|- Sponsor/Initiator ||Orbis Medisch Centrum|
(Source(s) of Monetary or Material Support)
|Department of Orthopedic Surgery, Orbis Medisch Centrum, Geleen, the Netherlands|
|- Publications||Fast-track total knee arthroplasty in a patient with Parkinsonís disease
Martijn GM Schotanus (MSc), Bas van Dun (MD), Nanne P Kort (MD, PhD)
NtvO, September 2014|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||5-dec-2011 - 18-aug-2015|