Hip InjuriesMIDASNCT03527407
MIDAS: Minimal-dataset for the Assessment of Surgical Outcomes - Potential in Hip Surgery
An observational study of Hip Injuries, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Swiss legislation requires health service providers to collect such information. of medical quality indicators as part of the quality and performance audit (Article 22a KVG). In addition, comparisons of clinics or specialist specialists on cost and quality of results are required (Art. 49 (8)). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Injuries
- How many people
- 146 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2017to 6 Jan 2021
- 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
- Adult, Older adult
Study population: The current study has been designed to support decisions on how to define a minimal data set and how to organize data collection to obtain valid data. Two patient groups will serve as an example: 1. patients with arthritis of the hip joint and indication for total prosthetic joint replacement surgery 2. patients with acute femoral neck fracture and indication for partial or total prosthetic joint replacement surgery
Who may be able to join
- Standard therapy of one of the following diagnoses
- Femoral neck fracture after low-energy trauma (implantation of a head endoprosthesis)
- Coxarthrosis (implantation of a total hip prosthesis)
Who cannot join
- Rejection of study participation or standard therapy
- Patients who are unlikely to attend routine follow-up (e.g., tourists)
- Patients in palliative care
- Malignancy (known or diagnosed in the course of time)
- Patients with a limited knowledge of German, who can answer the questionnaire even with the help of a study nurse seems unrealistic
- Participation in an interfering clinical intervention study within the last three months
- persons unable to consent (long-term incapacity to consent)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopedic and Trauma Surgery, University Hospital Basel
Basel, 4031
About this study
Official title: MIDAS: Minimal-dataset for the Assessment of Surgical Outcomes - Potential in Hip Surgery (ch18Jakob3)
Swiss legislation requires health service providers to collect such information. of medical quality indicators as part of the quality and performance audit (Article 22a KVG). In addition, comparisons of clinics or specialist specialists on cost and quality of results are required (Art. 49 (8)).
Currently, the quality of a medical therapy is evaluated rather negatively on the absence (or occurrence) of complications. In contrast, however, the goal of therapy must be to improve or maintain the health-related quality of life (HRQoL). Accordingly, the Swiss Society of Surgery (SGC-SSC), in collaboration with the Association for Quality Assurance in Surgery (AQC), has developed a minimum dataset designed to assess the quality of life of patients after surgical intervention. In order to enable Switzerland to be comparatively independent of the discipline, generic (in the Research Plan - MIDAS -V2, date 24.05.2017 Page 5/57 Contrary to disease-specific) survey instruments proposed that cover the general quality of life in its different facets, regardless of the function of individual organ systems. The complication documentation was not completely abandoned in this proposal, but is only a quality indicator among many due to patient-related outcome measurements.
Read more
However, the development of a minimal data set with quality indicators that are applicable across all surgical sub-disciplines for evaluating the quality of treatment of acute and chronic diseases raises a number of fundamental questions that can only be answered to a limited extent without empirical studies. Five essential questions are:
- Is it sufficient to work with generic quality of life tools or is it necessary to use disease / indication specific instruments or functional tests? II. Which is the best, solid time for a follow-up? III. Is it possible and useful to make a third-party determination of the quality of life in patients with limited cognitive abilities? IV. Which preoperative risk factors should be documented so that sufficient adjustment for case mix differences in hospital comparisons can be made? V. Which perioperative and postoperative factors, in particular complications, must be raised beyond the quality of life, as they reflect an independent aspect of quality?
- Conditions
- Hip Injuries
- Medical subject headings
- Hip Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to Baseline in the generic scores EuroQuol5 (EQ-5D)
The degree of mapping the influence of known factors for the quality of therapy to changes to Baseline in the generic scores EuroQuol5 (EQ-5D).
different measuring times between 3 and 12 months.
Measured: baseline, month 3 and month 12
Changes to Baseline in the Health Utility Index Mark 3 (HUI3)
The degree of mapping the influence of known factors for the quality of therapy to changes to Baseline in the Health Utility Index Mark 3 (HUI3).
different measuring times between 3 and 12 months.
Measured: baseline, month 3 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start1 Jul 2017
- Primary completion6 Jan 2021
- Study completion6 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcel Jakob, Prof MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527407
- Sponsor's protocol ID
- 2017-00763; ch18Jakob3
- Other IDs
- 2017
- Acronym
- MIDAS
- Status last verified
- Nov 2021
- First submitted
- 16 Apr 2018
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIDAS: Minimal-dataset for the Assessment of Surgical Outcomes - Potential in Hip Surgery (ch18Jakob3)
- ClinicalTrials.gov ID
- NCT03527407
- Acronym / sponsor ID
- MIDAS / 2017-00763; ch18Jakob3
- Conditions
- Hip Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 17 May 2018 (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.
Swiss legislation requires health service providers to collect such information. of medical quality indicators as part of the quality and performance audit (Article 22a KVG). In addition, comparisons of clinics or specialist specialists on cost and quality of results are required (Art. 49 (8)).
Currently, the quality of a medical therapy is evaluated rather negatively on the absence (or occurrence) of complications. In contrast, however, the goal of therapy must be to improve or maintain the health-related quality of life (HRQoL). Accordingly, the Swiss Society of Surgery (SGC-SSC), in collaboration with the Association for Quality Assurance in Surgery (AQC), has developed a minimum dataset designed to assess the quality of life of patients after surgical intervention. In order to enable Switzerland to be comparatively independent of the discipline, generic (in the Research Plan - MIDAS -V2, date 24.05.2017 Page 5/57 Contrary to disease-specific) survey instruments proposed that cover the general quality of life in its different facets, regardless of the function of individual organ systems. The complication documentation was not completely abandoned in this proposal, but is only a quality indicator among many due to patient-related outcome measurements.
However, the development of a minimal data set with quality indicators that are applicable across all surgical sub-disciplines for evaluating the quality of treatment of acute and chronic diseases raises a number of fundamental questions that can only be answered to a limited extent without empirical studies. Five essential questions are:
- Is it sufficient to work with generic quality of life tools or is it necessary to use disease / indication specific instruments or functional tests? II. Which is the best, solid time for a follow-up? III. Is it possible and useful to make a third-party determination of the quality of life in patients with limited cognitive abilities? IV. Which preoperative risk factors should be documented so that sufficient adjustment for case mix differences in hospital comparisons can be made? V. Which perioperative and postoperative factors, in particular complications, must be raised beyond the quality of life, as they reflect an independent aspect of quality?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The current study has been designed to support decisions on how to define a minimal data set and how to organize data collection to obtain valid data. Two patient groups will serve as an example: 1. patients with arthritis of the hip joint and indication for total prosthetic joint replacement surgery 2. patients with acute femoral neck fracture and indication for partial or total prosthetic joint replacement surgery
Key inclusion criteria (3 listed)
- Standard therapy of one of the following diagnoses
- Femoral neck fracture after low-energy trauma (implantation of a head endoprosthesis)
- Coxarthrosis (implantation of a total hip prosthesis)
Key exclusion criteria (7 listed)
- Rejection of study participation or standard therapy
- Patients who are unlikely to attend routine follow-up (e.g., tourists)
- Patients in palliative care
- Malignancy (known or diagnosed in the course of time)
- Patients with a limited knowledge of German, who can answer the questionnaire even with the help of a study nurse seems unrealistic
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
Changes to Baseline in the generic scores EuroQuol5 (EQ-5D)
Time frame: baseline, month 3 and month 12
The degree of mapping the influence of known factors for the quality of therapy to changes to Baseline in the generic scores EuroQuol5 (EQ-5D). different measuring times between 3 and 12 months.
Changes to Baseline in the Health Utility Index Mark 3 (HUI3)
Time frame: baseline, month 3 and month 12
The degree of mapping the influence of known factors for the quality of therapy to changes to Baseline in the Health Utility Index Mark 3 (HUI3). different measuring times between 3 and 12 months.
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 18 Nov 2021.
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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.
Marcel Jakob, Prof MD principal investigator
University Hospital, Basel, Switzerland
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 Injuries, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 7 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 18 Nov 2021. 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 Switzerland. 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?
Changes to Baseline in the generic scores EuroQuol5 (EQ-5D) (time frame: baseline, month 3 and month 12). The study lists 2 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 18 Nov 2021.