The relation between pre-operative parameters and patient satisfaction after Total Knee Arthroplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28068

Enrollment

Registered

2020-05-13

Start date

2020-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who require TKA as a result of arthritis

Interventions

moveUP (a CE certified medical device

www.moveup.care) is a digital platform which will be used to provide daily follow up and tele-rehabilitation for patients.

Eligibility

Inclusion criteria

Inclusion criteria: • Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved • Body-mass-index (BMI) below 35 kg/m2 • High need to obtain pain relief and improve function • Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations • Ability to work with a mobile device for tele-rehabilitation • Consent form read, understood and signed by patient

Exclusion criteria

Exclusion criteria: • Correction or revision of previous knee joint replacement procedure • Patients selected for a posterior stabilized implant type • Failure of previous joint replacement • Patients with severe pre-operative varus or valgus deformity greater than or equal to 15 degrees • BMI greater than or equal to 35 kg/m2 • Not able or willing to undergo MRI and CT scan • Metal near knee joint (MRI-scan not possible) • Non-correctable varus axis • Uncooperative patient or patient with neurological disorders who is incapable of following directions

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to identify correlations between pre-operative parameters and patient satisfaction after TKA surgery. Pre-operative parameters consist of biomechanical parameters, i.e. kinematics, ligament elongations and contact forces over the range of flexion motion, and planning parameters, i.e. bone geometrical dimensions and hip-knee-ankle angle. Patient satisfaction consists of patient reported outcome measures, i.e. KSS and daily pain scores, and objective measures, i.e. activity and video-based evaluation of range of motion and gait.	—

Measure

Time frame

The primary objective of this study is to identify correlations between pre-operative parameters and patient satisfaction after TKA surgery. Pre-operative parameters consist of biomechanical parameters, i.e. kinematics, ligament elongations and contact forces over the range of flexion motion, and planning parameters, i.e. bone geometrical dimensions and hip-knee-ankle angle. Patient satisfaction consists of patient reported outcome measures, i.e. KSS and daily pain scores, and objective measures, i.e. activity and video-based evaluation of range of motion and gait.

—

Secondary

Measure	Time frame
• To investigate whether the pre-operatively planned implant position corresponds to the post-operative implant position as measured on CT scan • To investigate whether soft tissue releases are necessary during surgery, in which cases and to what extent	—

Contacts

Public ContactMartijn Schotanus

Zuyderland Medisch Centrum

m.schotanus@zuyderland.nl06-52377871

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)