Gait Kinematics After Primary Total Knee Arthroplasty (TKA) Versus Revision TKA

Completed

• Conditions: Gait Analysis; Knee Arthroplasty, Total
• Interventions: Device: Group primary TKA; Device: Group TKA revision

• Registration Number: NCT03898544
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The functional outcomes after TKA are satisfying with a full recovery at 6 months - 1 year. Nevertheless, the revisions of TKA have often lower functional results than primary TKA with a long delay of recovery. The Stryker TKA present the same device for primary TKA and for revision.

The aim of this study is to compare the gait kinematics at 6 months after primary Stryker TKA or Revision Stryker TKA to assess if the objective outcomes are similar with this device.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-18
• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-03-29
• Study First Posted: 2019-04-02
• Primary Completion: 2020-09-10
• Study Completion: 2020-09-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Primary TKA group: symptomatic femorotibial osteoarthritis, with an indication of primary TKA (as Triathlon Stryker)
• Revision group: first TKA removal in 1 step for mechanical failure, by a revision TKA (as Triathlon Stryker)

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Exclusion Criteria

• Septic failure
• Second or more failure in the revision group
• Associated surgical procedure as osteotomy, allograft...
• Not full weight bearing postoperatively
• Refusal to participate

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group primary TKA	Group primary TKA	Patients operated of primary TKA Stryker for knee osteoarthritis.
Group TKA revision	Group TKA revision	Patients operated of a first revision of TKA for a mechanical failure, with the revision Stryker TKA

Primary Outcome Measures

Name	Time	Method
Femorotibial mechanical axis (varus, valgus) analysis	at 6 months postoperatively	These parameters are measured with the KneeKG system during the walking
Walking speed	at 6 months postoperatively	These parameter is measured with the KneeKG system
range of motion (flexion, extension) analysis	at 6 months postoperatively	These parameters are measured with the KneeKG system during the walking
internal/external rotation analysis	at 6 months postoperatively	These parameter is measured with the KneeKG system during the walking

Trial Locations

Locations (1)

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France