Hip and Knee Scores

Knee Osteoarthritis Clinical Trial

— HIP-KNEE  

Official title:

Study of Self-assessment Questionnaires Used in Hip and Knee Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04057651
• Other study ID #: 2016_72
• Secondary ID: 2017-A01911-52
• Status: Completed
• Start date: August 28, 2018
• Est. completion date: May 19, 2020

Study information

• Verified date: September 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: May 19, 2020
• Est. primary completion date: May 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hip osteoarthritis (certified by standard radiographs)

• Knee osteoarthritis ( certified by standard radiographs)

Exclusion Criteria:

• BMI = 40

• Systemic inflammatory disease

• Pregnant

• Surgery revision

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	KOOS score	Knee injury and Osteoarthritis Outcome Score (KOSS)	The day Before surgery
Primary	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	Oxford Hip Score		an average between 6 to 9 months after surgery
Secondary	HOOS Score		an average between 6 to 9 months after surgery
Secondary	KOOS score		an average between 6 to 9 months after surgery
Secondary	Oxford knee Score		an average between 6 to 9 months after surgery