Effect of a smart ring-assisted physiotherapeutic intervention on the postoperative outcomes 12 months after a total knee replacement (SmarTKRing): protocol for a randomised controlled trial
Introduction This protocol assesses the effect of a wearable activity tracker-assisted physiotherapeutic intervention on postoperative outcomes in patients undergoing total knee replacement (TKR) surgery. Despite advancements in TKR technology, patient dissatisfaction remains a concern, with adheren...
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BMJ Publishing Group
2025-05-01
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| author | Ville Mattila Antti Eskelinen Aleksi Reito Joni Hautala Laura Koriseva |
| author_facet | Ville Mattila Antti Eskelinen Aleksi Reito Joni Hautala Laura Koriseva |
| author_sort | Ville Mattila |
| collection | DOAJ |
| description | Introduction This protocol assesses the effect of a wearable activity tracker-assisted physiotherapeutic intervention on postoperative outcomes in patients undergoing total knee replacement (TKR) surgery. Despite advancements in TKR technology, patient dissatisfaction remains a concern, with adherence to physical activity guidelines being particularly poor among those with knee osteoarthritis. The primary aim of this trial is to evaluate the effectiveness of a smart ring-assisted physiotherapeutic intervention in improving outcomes, as measured by the Oxford Knee Score (OKS), 12 months after a TKR.Methods and analysis We are conducting this randomised controlled trial at Coxa Hospital for Joint Replacement in Finland, where participants are randomly assigned to either an intervention with smart ring-supported physiotherapeutic intervention or a usual care control group in a 1:1 ratio in patients undergoing TKR surgery. The primary outcome measure is the OKS at 12 months after surgery. Secondary outcomes encompass OKS variance, poor postoperative outcome (defined as ≤7 points change on the OKS), quality of life questionnaire EuroQol 5-Dimensions 5-Levels(EQ-5D-5L), knee range of motion, pain scores, patient satisfaction and healthcare resource utilisation. The study population comprises patients aged 18–70 undergoing unilateral primary TKR for knee osteoarthritis. Statistical analysis involves logistic regression and linear mixed models to assess group differences in outcomes over time, with adjustments for relevant covariates.Ethics and dissemination The trial was approved by the Tampere University Hospital Ethical Committee (R22078) and participants are required to provide written informed consent. Procedures in conducting the trial are aligned with the principles of Good Scientific Practice outlined by the Finnish Advisory Board on Research Integrity. The results of this trial will be disseminated as a series of articles published in a peer-reviewed medical journal.Trial registration number NCT05599776. |
| format | Article |
| id | doaj-art-936c98e9577446608cc08a032a0a5cc8 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-936c98e9577446608cc08a032a0a5cc82025-08-20T03:09:54ZengBMJ Publishing GroupBMJ Open2044-60552025-05-0115510.1136/bmjopen-2024-091956Effect of a smart ring-assisted physiotherapeutic intervention on the postoperative outcomes 12 months after a total knee replacement (SmarTKRing): protocol for a randomised controlled trialVille Mattila0Antti Eskelinen1Aleksi Reito2Joni Hautala3Laura Koriseva4Tuki ja liikuntaelinsairauksien vastuualue, Tampereen yliopistollinen sairaala, Tampere, FinlandCoxa Hospital for Joint Replacement, Tampere, FinlandDepartment of Orthopaedics and Traumatology, Tampere University Hospital, Tampere, FinlandFaculty of Medicine, Tampere University, Tampere, FinlandCoxa Hospital Ltd, Tampere, FinlandIntroduction This protocol assesses the effect of a wearable activity tracker-assisted physiotherapeutic intervention on postoperative outcomes in patients undergoing total knee replacement (TKR) surgery. Despite advancements in TKR technology, patient dissatisfaction remains a concern, with adherence to physical activity guidelines being particularly poor among those with knee osteoarthritis. The primary aim of this trial is to evaluate the effectiveness of a smart ring-assisted physiotherapeutic intervention in improving outcomes, as measured by the Oxford Knee Score (OKS), 12 months after a TKR.Methods and analysis We are conducting this randomised controlled trial at Coxa Hospital for Joint Replacement in Finland, where participants are randomly assigned to either an intervention with smart ring-supported physiotherapeutic intervention or a usual care control group in a 1:1 ratio in patients undergoing TKR surgery. The primary outcome measure is the OKS at 12 months after surgery. Secondary outcomes encompass OKS variance, poor postoperative outcome (defined as ≤7 points change on the OKS), quality of life questionnaire EuroQol 5-Dimensions 5-Levels(EQ-5D-5L), knee range of motion, pain scores, patient satisfaction and healthcare resource utilisation. The study population comprises patients aged 18–70 undergoing unilateral primary TKR for knee osteoarthritis. Statistical analysis involves logistic regression and linear mixed models to assess group differences in outcomes over time, with adjustments for relevant covariates.Ethics and dissemination The trial was approved by the Tampere University Hospital Ethical Committee (R22078) and participants are required to provide written informed consent. Procedures in conducting the trial are aligned with the principles of Good Scientific Practice outlined by the Finnish Advisory Board on Research Integrity. The results of this trial will be disseminated as a series of articles published in a peer-reviewed medical journal.Trial registration number NCT05599776.https://bmjopen.bmj.com/content/15/5/e091956.full |
| spellingShingle | Ville Mattila Antti Eskelinen Aleksi Reito Joni Hautala Laura Koriseva Effect of a smart ring-assisted physiotherapeutic intervention on the postoperative outcomes 12 months after a total knee replacement (SmarTKRing): protocol for a randomised controlled trial BMJ Open |
| title | Effect of a smart ring-assisted physiotherapeutic intervention on the postoperative outcomes 12 months after a total knee replacement (SmarTKRing): protocol for a randomised controlled trial |
| title_full | Effect of a smart ring-assisted physiotherapeutic intervention on the postoperative outcomes 12 months after a total knee replacement (SmarTKRing): protocol for a randomised controlled trial |
| title_fullStr | Effect of a smart ring-assisted physiotherapeutic intervention on the postoperative outcomes 12 months after a total knee replacement (SmarTKRing): protocol for a randomised controlled trial |
| title_full_unstemmed | Effect of a smart ring-assisted physiotherapeutic intervention on the postoperative outcomes 12 months after a total knee replacement (SmarTKRing): protocol for a randomised controlled trial |
| title_short | Effect of a smart ring-assisted physiotherapeutic intervention on the postoperative outcomes 12 months after a total knee replacement (SmarTKRing): protocol for a randomised controlled trial |
| title_sort | effect of a smart ring assisted physiotherapeutic intervention on the postoperative outcomes 12 months after a total knee replacement smartkring protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/15/5/e091956.full |
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