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Telephone follow-up by nurse following total knee arthroplasty - protocol for a randomized clinical trial (NCT 01771315).

ABSTRACT: BACKGROUND:Due to shorter hospitalization, patients have to take responsibility for their rehabilitation period at a very early stage. The objective of this trial is to study the effects of two treatment schemes following total knee arthroplasty: conventional treatment following discharge from hospital and early follow-up by telephone consultations in addition to conventional treatment following discharge from hospital. The ultimate aim is to increase the effectiveness of the treatment by improving patients' health status, promote self-efficacy, and reduce the number of acute visits to the orthopaedic outpatient clinic during the rehabilitation period. METHOD/DESIGN:The design is a randomized un-blinded parallel group clinical trial conducted at the Department of Orthopaedic Surgery, Gentofte Hospital, the Capital Region of Denmark. In total, 116 patients will be allocated by an external randomization program to 2 groups: an intervention group following usual treatment after discharge supplemented by a nurse managed structured follow-up consultation conducted by telephone 4 and 14 days after discharge from hospital and a control group following treatment as usual. The consultations are structured by key subjects relevant to assess the health status according to the VIPS-model (the Swedish acronym for the concepts Well-being, Integrity, Prevention and Safety). The content of the consultations can vary according to the patients´ individual situations and needs. All consultations are conducted by the researcher responsible for the trial. The effect is measured 1, 3, 6 and 12 months post-surgery. The primary outcome is self-reported physical function measured by The Western Ontario and McMaster Universities Arthritis Index. Secondary outcomes are self-reported health-related quality of life, general self-efficacy and the number of acute visits to the orthopaedic outpatient clinic. DISCUSSION:The result of this trial is expected to provide new knowledge to support the development of targeted and effective follow-up after total knee arthroplasty in order to improve the patients´ health-related knowledge and skills of being able to take actively part in their illness and improve their health status. TRIAL REGISTRATION:ClinicalTrials.gov: NCT01771315.

SUBMITTER: Szots K

PROVIDER: S-EPMC4035798 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Telephone follow-up by nurse following total knee arthroplasty - protocol for a randomized clinical trial (NCT 01771315).

Szöts Kirsten K Konradsen Hanne H Solgaard Søren S Ostergaard Birte B

BMC nursing 20140521

<h4>Background</h4>Due to shorter hospitalization, patients have to take responsibility for their rehabilitation period at a very early stage. The objective of this trial is to study the effects of two treatment schemes following total knee arthroplasty: conventional treatment following discharge from hospital and early follow-up by telephone consultations in addition to conventional treatment following discharge from hospital. The ultimate aim is to increase the effectiveness of the treatment b ...[more]

PMID: 24872728

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Project description:BackgroundMore personalized implant designs for total knee arthroplasty might optimize the clinical outcome after surgery. One of these personalized implant designs is the Persona knee implant system (Zimmer Biomet, Warsaw, Indiana, USA). The primary objective of this study was to determine patient reported outcomes and implant survivorship of the Persona Knee system used in primary total knee arthroplasty, up to two years after surgery.MethodsFrom November 2013 to July 2016 consecutive patients undergoing primary total knee arthroplasty were enrolled in a prospective observational cohort study at three centers. Preoperatively, at 6 weeks, 6 months, 1 and 2 years after surgery, patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Oxford Knee Score (OKS), the Knee Society Score (KSS, 2011, modified version) and the EQ-5D. Adverse Events were captured, assessed for relationship to device, and recorded in the study database. Furthermore, physical functioning was assessed by the orthopedic surgeon. Repeated measures analyses were performed on PROM scores. Kaplan Meier was used to calculate survivorship of the Persona Knee Implant System.ResultsA total of 146 total knee arthroplasties were performed. 61% (89/146) of the patients were female and mean age was 64.7 (± 6.9) years. Two years after surgery, one patient had a revision of the polyethylene insert because of a periprosthetic joint infection. Therefore, the Kaplan-Meier survival estimate at 2 years was 0.99 (0.95-1.00 95% CI). OKS increased from 22.1 (95% CI 20.9-23.3) to 41.8 (95% CI 40.6-43.1) two years after surgery. Furthermore, all other PROMs also increased from before surgery to 2 year postoperatively.ConclusionThe Persona Knee implant is safe and effective and the clinical results up to two years after surgery are promising. PROMs results are very good; pain, function and quality of life all improved greatly after TKA. Further studies are needed to determine the long term clinical performance of the Persona prosthesis.Trial registrationClinicaltrials.gov ( NCT02337244 ). Registered June 1st, 2015. Retrospectively registered.

Dataset Information

Telephone follow-up by nurse following total knee arthroplasty - protocol for a randomized clinical trial (NCT 01771315).

Publications

Telephone follow-up by nurse following total knee arthroplasty - protocol for a randomized clinical trial (NCT 01771315).

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