NCT04057651

Brief Summary

Patient-reported outcome measures (PROMs) are currently used for evaluating orthopaedic procedures. Nevertheless, there is no consensus in the different studies, making them difficult to compare . The score mapping (or cross walk) is a statistical model for estimating a score associated with an unmeasured score. Moreover , Minimal clinically important differences (MCID) is the smallest change in a treatment outcome that a patient would identify as important. The MCID is also not clearly identified for the French population for the hip and knee orthopaedic scores.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 28, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2020

Completed
Last Updated

May 14, 2026

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

August 13, 2019

Last Update Submit

May 11, 2026

Conditions

Hip OsteoarthritisKnee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

  • Oxford Hip Score

    t is a 12-item patient-reported outcome measure designed to assess disability after surgery to the hip. Each item was scored between 0 and 4, with 4 been the best outcome per question producing overall scores running from 0 to 48(48 being the best outcome); \> 41 is excellent, 34 - 41 is good,27 -33 as fair, and \<27 is poor.

    The day Before surgery

  • HOOS Score

    The HOOS (Hip disability and Osteoarthritis Outcome Score) is a patient questionnaire evaluating patients' feelings about their operated hip. It consists of 40 questions divided into 5 subgroups: pain, symptoms, daily living, quality of life, sports and recreational activities. Each category is scored on 100 points, 0 being the worse outcome and 100 the best outcome.

    The day Before surgery

  • KOOS score

    Knee injury and Osteoarthritis Outcome Score (KOSS)

    The day Before surgery

  • Oxford knee score

    Oxford Knee Score is a tool which measures 6 post operative items (pain,flexion contracture, extension lag, total range of flexion, alignment of varus and valgus,stability (antero-posterior and mediolateral). The scoring is: below 60 is poor, scoring 60-69 fair, scoring 70-79 good, 80-100 excellent.

    The day Before surgery

Secondary Outcomes (4)

  • Oxford Hip Score

    an average between 6 to 9 months after surgery

  • HOOS Score

    an average between 6 to 9 months after surgery

  • KOOS score

    an average between 6 to 9 months after surgery

  • Oxford knee Score

    an average between 6 to 9 months after surgery

Study Arms (2)

Hip osteoarthritis waiting for surgery

Knee osteoarthritis waiting for surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hip and knee patients waiting for hip and knee arthroplasty

You may qualify if:

  • Hip osteoarthritis (certified by standard radiographs)
  • Knee osteoarthritis ( certified by standard radiographs)

You may not qualify if:

  • BMI ≥ 40
  • Systemic inflammatory disease
  • Pregnant
  • Surgery revision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Roger Salengro, CHU

Lille, France

Location

Related Publications (2)

  • Putman S, Preda C, Girard J, Duhamel A, Migaud H. Mapping and Crosswalk of the Oxford Hip Score and Different Versions of the Hip Disability and Osteoarthritis Outcome Score. Clin Orthop Relat Res. 2021 Jul 1;479(7):1534-1544. doi: 10.1097/CORR.0000000000001675.

    PMID: 34128911RESULT

  • Putman S, Dartus J, Migaud H, Pasquier G, Girard J, Preda C, Duhamel A. Can the minimal clinically important difference be determined in a French-speaking population with primary hip replacement using one PROM item and the Anchor strategy? Orthop Traumatol Surg Res. 2021 May;107(3):102830. doi: 10.1016/j.otsr.2021.102830. Epub 2021 Jan 29.

    PMID: 33524632DERIVED

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Sophie Putman, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 15, 2019

Study Start

August 28, 2018

Primary Completion

May 19, 2020

Study Completion

May 19, 2020

Last Updated

May 14, 2026

Record last verified: 2020-09

Locations

FR(1)