HIP REPLACEMENTALLCCPNCT04199377
Retrospective Evaluation of Clinical and Functional Results and Survivorship of Total Knee Replacement and Total Hip Replacement, Both Isolated or Combined.
A study testing HIP KNEE REPLACEMENT in people with HIP REPLACEMENT and KNEE REPLACEMENT, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Retrospective evaluation of clinical and functional results and survivorship of total knee replacement and total hip replacement, both isolated or combined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIP REPLACEMENT, KNEE REPLACEMENT
- What is being tested?
- HIP KNEE REPLACEMENT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 20 Oct 2017to 1 Jan 2021
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years
- Patients underwent total knee or hip replacement, both isolated or combined with other surgical procedures
Who cannot join
- Patients underwent other types of knee or hip replacement
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Irccs Istituto Ortopedico Galeazzi
Milan, 20161
SERGIO ROMAGNOLI, MD, 00390266214929, GIADA.GENTILE@GRUPPOSANDONATO.IT
About this study
Retrospective evaluation of clinical and functional results and survivorship of total knee replacement and total hip replacement, both isolated or combined.
Read the detailed description
Retrospective evaluation of clinical and functional results and survivorship of total knee replacement and total hip replacement, both isolated or combined.
Evaluation performed 1, 2, 5, 10 and 15 years after surgery
- Conditions
- HIP REPLACEMENT, KNEE REPLACEMENT
- Being tested
- HIP KNEE REPLACEMENT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIP KNEE REPLACEMENTProcedure or surgery
HIP KNEE REPLACEMENT
| Study group | Role | What they receive |
|---|---|---|
| hip or knee replacement | Experimental | total hip or knee replacement Receives: Procedure: HIP KNEE REPLACEMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
HARRIS HIP SCORE
scale range: 0-100; excellent results: 80-100
Measured: 10 years
KNEE SOCIETY SCORE
scale range: 0-100; excellent results: 80-100
Measured: 10 years
HARRIS HIP SCORE
scale range: 0-100; excellent results: 80-100
Measured: 5 years
KNEE SOCIETY SCORE
scale range: 0-100; excellent results: 80-100
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start20 Oct 2017
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIP REPLACEMENTStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199377
- Sponsor's protocol ID
- ALLCCP
- Acronym
- ALLCCP
- Status last verified
- Dec 2019
- First submitted
- 27 Nov 2017
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Clinical and Functional Results and Survivorship of Total Knee Replacement and Total Hip Replacement, Both Isolated or Combined.
- ClinicalTrials.gov ID
- NCT04199377
- Acronym / sponsor ID
- ALLCCP / ALLCCP
- Conditions
- HIP REPLACEMENT, KNEE REPLACEMENT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 13 Dec 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.
Retrospective evaluation of clinical and functional results and survivorship of total knee replacement and total hip replacement, both isolated or combined.
Detailed description
Retrospective evaluation of clinical and functional results and survivorship of total knee replacement and total hip replacement, both isolated or combined.
Evaluation performed 1, 2, 5, 10 and 15 years after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hip or knee replacement | Experimental | Procedure: HIP KNEE REPLACEMENTtotal hip or knee replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Patients underwent total knee or hip replacement, both isolated or combined with other surgical procedures
Key exclusion criteria (1 listed)
- Patients underwent other types of knee or hip replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIP KNEE REPLACEMENTHIP KNEE REPLACEMENT | Procedure or surgery | hip or knee replacement |
Primary outcome
HARRIS HIP SCORE
Time frame: 10 years
scale range: 0-100; excellent results: 80-100
KNEE SOCIETY SCORE
Time frame: 10 years
scale range: 0-100; excellent results: 80-100
HARRIS HIP SCORE
Time frame: 5 years
scale range: 0-100; excellent results: 80-100
KNEE SOCIETY SCORE
Time frame: 5 years
scale range: 0-100; excellent results: 80-100
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIP KNEE REPLACEMENT in people with HIP REPLACEMENT and KNEE REPLACEMENT, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Dec 2019. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HARRIS HIP SCORE (time frame: 10 years). 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?
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 13 Dec 2019.