Hip OsteoarthritisHIP-KNEENCT04057651
Hip and Knee Scores
An observational study of Hip Osteoarthritis and Knee Osteoarthritis, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Knee Osteoarthritis
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2018to 19 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hip and knee patients waiting for hip and knee arthroplasty
Who may be able to join
- Hip osteoarthritis (certified by standard radiographs)
- Knee osteoarthritis ( certified by standard radiographs)
Who cannot join
- BMI ≥ 40
- Systemic inflammatory disease
- Pregnant
- Surgery revision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Self-assessment Questionnaires Used in Hip and Knee Surgery
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.
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hip osteoarthritis waiting for surgery | Not described | |
| Knee osteoarthritis waiting for surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The day Before surgery
KOOS score
Knee injury and Osteoarthritis Outcome Score (KOSS)
Measured: 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.
Measured: The day Before surgery
Secondary outcomes (4)
Oxford Hip Score
Measured: an average between 6 to 9 months after surgery
HOOS Score
Measured: an average between 6 to 9 months after surgery
KOOS score
Measured: an average between 6 to 9 months after surgery
Oxford knee Score
Measured: an average between 6 to 9 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start28 Aug 2018
- Primary completion19 May 2020
- Study completion19 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Putman, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057651
- Sponsor's protocol ID
- 2016_72
- Other IDs
- 2017-A01911-52
- Acronym
- HIP-KNEE
- Status last verified
- Sep 2020
- First submitted
- 13 Aug 2019
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34128911Putman 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.
PubMed 33524632
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Self-assessment Questionnaires Used in Hip and Knee Surgery
- ClinicalTrials.gov ID
- NCT04057651
- Acronym / sponsor ID
- HIP-KNEE / 2016_72
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 19 May 2020 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip osteoarthritis waiting for surgery | – | – |
| Knee osteoarthritis waiting for surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hip and knee patients waiting for hip and knee arthroplasty
Key inclusion criteria (2 listed)
- Hip osteoarthritis (certified by standard radiographs)
- Knee osteoarthritis ( certified by standard radiographs)
Key exclusion criteria (4 listed)
- BMI ≥ 40
- Systemic inflammatory disease
- Pregnant
- Surgery revision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxford Hip Score
Time frame: The day Before surgery
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.
HOOS Score
Time frame: The day Before surgery
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.
KOOS score
Time frame: The day Before surgery
Knee injury and Osteoarthritis Outcome Score (KOSS)
Oxford knee score
Time frame: The day Before surgery
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.
4 secondary outcomes
Oxford Hip Score
Time frame: an average between 6 to 9 months after surgery
HOOS Score
Time frame: an average between 6 to 9 months after surgery
KOOS score
Time frame: an average between 6 to 9 months after surgery
Oxford knee Score
Time frame: an average between 6 to 9 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 34128911Putman 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.
- Derived from this study: PubMed 33524632Putman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Putman, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Osteoarthritis and Knee Osteoarthritis, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Hip Score (time frame: The day Before surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04057651, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.