NCT05182320

Brief Summary

Multicenter, Prospective, Randomized, Comparative Study Measuring the Effects on Clinical Outcomes, Patient Satisfaction, Costs and Benefits of Combined Pre-, Intra- and Postoperative Patient Data for THA and TKA Patients Using an APP Based Sensor for Home Exercise Performance Before and After Operation

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

Same day

First QC Date

December 1, 2021

Last Update Submit

August 24, 2023

Conditions

Arthroplasty, Replacement, HipArthroplasty, Replacement, KneeClinical OutcomePatient SatisfactionTreatment Cost

Keywords

randomized comparative studyclinical outcomeApp based sensorHome Exercise

Outcome Measures

Primary Outcomes (1)

  • Osteoarthritis Outcome Score

    The Patient self-assessed Injury and Osteoarthritis Outcome Scores for Knee (KOOS) and hip (HOOS) are joint-specific instruments: The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The HOOS evaluates both short-term and long-term consequences of hip injury. It holds 5 separate patient-relevant dimensions: Pain (P), Symptoms (S), Activity limitations daily living (ADL), Function in sport and recreation (SP) and hip related quality of life (QOL). Both scores are percentage scores from 0 to 100, 0 representing extreme problems and 100 representing no problems.

    12 weeks after surgery

Secondary Outcomes (9)

  • Patient satisfaction

    12 weeks after surgery

  • Patient User Experience

    at final follow-up approx. 7 months after surgery

  • Patient compliance

    at final follow-up approx. 7 months after surgery

  • Economical [time and costs]

    12 weeks after surgery

  • Course of Active Range of Motion

    repeatedly from pre-op consultation until final follow-up approx. 7 months after surgery

  • +4 more secondary outcomes

Study Arms (2)

OrthoPath

Device: OrthoPath

Control

Device: Control

Interventions

OrthoPathDEVICE

unilateral TKA and THA patients using the BPMpathway rehabilitation sensor system

OrthoPath
ControlDEVICE

unilateral TKA and THA patients not using the BPMpathway rehabilitation sensor system

Control

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing primary unilateral Total Knee and Hip Arthroplasty

You may qualify if:

  • Primary, unilateral total knee and hip replacement patients
  • Participant is min. 18 years of age
  • Participant is able and willing to provide written informed consent
  • Participant with ability to work with smart devices
  • Participant having its own device (Apple iPhone or iPad with latest iOS version or Android tablet or smart phone min. Android version 6) and are able to handle the app and/or sensor

You may not qualify if:

  • Pregnancy
  • Participant has mental in capabilities - unable to give informed consent
  • Participants who are unwilling or mentally and/or physically unable to adhere to study procedures
  • Participant is having orthopaedic co-morbidities such as: previous HTO at indexed joint or prior UKA
  • Flexion contracture \> 15°
  • Varus/valgus deformity \> 10°
  • Participant is having dementia or other cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sportklinik Ravensburg GmbH & Co. KG

Ravensburg, Baden-Wurttemberg, 88214, Germany

Location

RHÖN-KLINIKUM Campus Bad Neustadt

Bad Neustadt an der Saale, 97616, Germany

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2021

First Posted

January 10, 2022

Study Start

June 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)