CoxarthrosisNCT07199751
Comparison of Complication Rate, Functional Outcome and Quality of Life Between Standard Therapy Versus Fast-track Therapy in Patients Following Hip Replacement Surgery
An observational study of Coxarthrosis, run by Technical University of Munich at 1 site in Germany.
Trial summary
The fast track group vs. control group will be compared with regard to hospitalization time and the non-inferiority of the fast track group vs. control group with regard to HOOS will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coxarthrosis
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 arthroplasty elective
Who may be able to join
- Age ≥18 years
- The patient will undergo surgery at Klinikum rechts der Isar, Technical University of Munich (TUM)
- Written informed consent for participation in the study after detailed explanation of the nature, significance, risks and scope of the clinical trial
- Written informed consent from the patient for data collection and data processing, with the patient fully informed.
- Sufficient German language skills of the patient.
Who cannot join
- Age < 18 years
- The patient is under guardianship, legally incapacitated or has limited legal capacity
- Only partial weight-bearing permitted
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department Physical Therapy
München, 81675
About this study
Official title: Vergleich Der Komplikationsrate, Des Funktionellen Outcomes Und Der Lebensqualität Zwischen Standard Therapie Versus Fast Track Therapie Bei Patienten Und Patientinnen Nach Hüft-TEP Operationen
The fast track group vs. control group will be compared with regard to hospitalization time and the non-inferiority of the fast track group vs. control group with regard to HOOS will be assessed.
The questionnaires will only be collected in the study: Eq-5d-5l, HOOS, self-efficacy, enjoyment of movement, fear of movement, pain catastrophizing.
Read the detailed description
Around 400,000 hip and knee endoprostheses are implanted in Germany every year. Due to demographic change, the trend is clearly on the rise, which also results in rising costs in this area for the solidarity community. The Clinic for Orthopaedics and Sports Orthopaedics at the TUM Clinic is about to implement the Fast Track method after total hip arthroplasty (THA, in German: Hüft-TEP). The aim of this method is to shorten the length of stay in hospital and the post-operative recovery time as well as to promote rapid mobilization and independence of patients without worsening the functional outcome or the complication rate. The investigators will therefore investigate the extent to which it is possible to reduce the length of hospital stay without compromising function.
- Primary endpoints: Hospital length of stay, HOOS.
- Secondary endpoints: PROMs Quality of life Eq-5d-5l (EuroQol 5 dimensions Lang) Function Mobility (TUG test) in seconds Pain (NRS), ROM (neutral zero method), Strength (Nm/kg body weight, muscle function test) Self-efficacy/ pleasure/ fear of movement/pain catastrophizing Exercise self efficacy scale (ESES), physical activity enjoyment scale (PACES), Kinesiophobia (TSK), Pain catastrophizing scale (PCS).
With an original length of stay of 6 days and a target length of stay of 4 days, the expected reduction is 2 days. A standard deviation of 3 days is assumed in both groups (calculations based on patient data from August to December 2024) and a significance level of 0.05 and power of 80% are assumed. The required number of cases is therefore at least 36 participants per group. With this number of cases, the non-inferiority of the fast-track method compared to the standard method with regard to HOOS can also be demonstrated with a probability of 80%, assuming that the true mean difference between the methods is 0 points and the standard deviation for both methods is 15 points (Δ = 10 points, one-sided 97.5% confidence interval). To compensate for a potential drop-out rate, 45 patients per group should be recruited. With a primary hip TEP (THA) surgery rate of approx. 10 patients per week (cf. 2024) and a 2-month duration per group, the investigators can recruit a maximum of 80 patients per group. The investigators are therefore confident that the required case number of 45 per group will be reached.
- Conditions
- Coxarthrosis
- Keywords
- enhanced recovery, physiotherapy
- Medical subject headings
- Osteoarthritis, Hip
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 |
|---|---|---|
| Fast Track | enhanced Recovery | |
| standard therapy | standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay (days)
The total number of days a participant remains admitted in the hospital from the day of surgery until discharge. While the expected length of stay is approximately 4 days, some participants may stay longer depending on clinical needs.
Measured: From day of surgery until discharge, up to 4 days post-surgery
Hip Disability and Osteoarthritis Outcome Score (HOOS)
The Hip Disability and Osteoarthritis Outcome Score (HOOS) is a validated, patient-reported instrument for assessing hip-related pain, function, and quality of life.
Scores range from 0 to 100, with higher scores indicating better outcomes (less pain, better function, improved quality of life).
Measured: From baseline (pre-surgery) to 3 months post-surgery
Secondary outcomes (8)
Timed Up and Go (TUG) Test
The Timed Up and Go (TUG) test is a functional mobility test measuring the time (in seconds) required for a participant to rise from a chair, walk 3 meters, turn, walk back, and sit down again. Shorter times indicate better functional mobility.
Measured: From baseline (pre-surgery) to 3 months post-surgery
EQ-5D-5L (EuroQol 5 Dimensions, 5 Levels)
The EQ-5D-5L (EuroQol 5 Dimensions, 5 Levels) measures health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It also includes a visual analogue scale (VAS) for overall health.
Index values are calculated using country-specific preference weights and typically range from 1 (full health) to 0 (equivalent to death), with negative values representing health states considered worse than death (e.g., -0.205 to 1.000 in Germany).
Measured: From baseline (pre-surgery) to 3 months post-surgery
Range of Motion (ROM) - Neutral Zero Method (degrees)
Joint range of motion (ROM) assessed using the neutral zero method, measuring the maximal angle achieved at the hip joint. Higher values indicate greater mobility.
Measured: From baseline (pre-surgery) to 3 months post-surgery
Exercise Self-Efficacy Scale (ESES)
The Exercise Self-Efficacy Scale (ESES) assesses an individual's confidence in their ability to engage in and maintain regular exercise, even under challenging circumstances, such as a busy work schedule, fatigue, being on vacation, or feeling stressed. Scores range from 6 to 60, with higher scores indicating greater self-efficacy for exercise.
Measured: From baseline (pre-surgery) to 3 months post-surgery
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) measures the extent of negative thoughts and feelings related to pain.
Scores range from 0 to 52, with higher scores indicating greater pain catastrophizing (worse outcome).
Measured: From baseline (pre-surgery) to 3 months post-surgery
Tampa Scale for Kinesiophobia (TSK)
The Tampa Scale for Kinesiophobia (TSK) assesses fear of movement and avoidance of physical activity due to pain-related concerns.
Scores range from 17 to 68, with higher scores indicating greater kinesiophobia (worse outcome).
Measured: From baseline (pre-surgery) to 3 months post-surgery
Muscle Strength (Nm/kg body weight)
Maximal isometric muscle strength normalized to body weight, measured in Newton-meters per kilogram. Higher values indicate greater muscle strength.
Measured: From baseline (pre-surgery) to 3 months post-surgery
Physical Activity Enjoyment Scale (PACES)
The Physical Activity Enjoyment Scale (PACES) assesses an individual's level of enjoyment during physical activity. Total scores range from 4 to 20, with higher scores indicating greater enjoyment of physical activity.
Measured: From baseline (pre-surgery) to 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoxarthrosisStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BarbaraVogel, Technical University of Munich
- Investigators
- Rüdiger von Eisenhart-Rothe, Prof. Dr., Study director, Department of Orthopedics and Sports Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199751
- Sponsor's protocol ID
- 2025-155-S-CB
- Status last verified
- Sep 2025
- First submitted
- 7 Jul 2025
- Last updated
- 30 Sep 2025
- 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 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vergleich Der Komplikationsrate, Des Funktionellen Outcomes Und Der Lebensqualität Zwischen Standard Therapie Versus Fast Track Therapie Bei Patienten Und Patientinnen Nach Hüft-TEP Operationen
- ClinicalTrials.gov ID
- NCT07199751
- Acronym / sponsor ID
- 2025-155-S-CB
- Conditions
- Coxarthrosis
- Keywords
- enhanced recovery, physiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Sep 2025 (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.
The fast track group vs. control group will be compared with regard to hospitalization time and the non-inferiority of the fast track group vs. control group with regard to HOOS will be assessed.
The questionnaires will only be collected in the study: Eq-5d-5l, HOOS, self-efficacy, enjoyment of movement, fear of movement, pain catastrophizing.
Detailed description
Around 400,000 hip and knee endoprostheses are implanted in Germany every year. Due to demographic change, the trend is clearly on the rise, which also results in rising costs in this area for the solidarity community. The Clinic for Orthopaedics and Sports Orthopaedics at the TUM Clinic is about to implement the Fast Track method after total hip arthroplasty (THA, in German: Hüft-TEP). The aim of this method is to shorten the length of stay in hospital and the post-operative recovery time as well as to promote rapid mobilization and independence of patients without worsening the functional outcome or the complication rate. The investigators will therefore investigate the extent to which it is possible to reduce the length of hospital stay without compromising function.
- Primary endpoints: Hospital length of stay, HOOS.
- Secondary endpoints: PROMs Quality of life Eq-5d-5l (EuroQol 5 dimensions Lang) Function Mobility (TUG test) in seconds Pain (NRS), ROM (neutral zero method), Strength (Nm/kg body weight, muscle function test) Self-efficacy/ pleasure/ fear of movement/pain catastrophizing Exercise self efficacy scale (ESES), physical activity enjoyment scale (PACES), Kinesiophobia (TSK), Pain catastrophizing scale (PCS).
With an original length of stay of 6 days and a target length of stay of 4 days, the expected reduction is 2 days. A standard deviation of 3 days is assumed in both groups (calculations based on patient data from August to December 2024) and a significance level of 0.05 and power of 80% are assumed. The required number of cases is therefore at least 36 participants per group. With this number of cases, the non-inferiority of the fast-track method compared to the standard method with regard to HOOS can also be demonstrated with a probability of 80%, assuming that the true mean difference between the methods is 0 points and the standard deviation for both methods is 15 points (Δ = 10 points, one-sided 97.5% confidence interval). To compensate for a potential drop-out rate, 45 patients per group should be recruited. With a primary hip TEP (THA) surgery rate of approx. 10 patients per week (cf. 2024) and a 2-month duration per group, the investigators can recruit a maximum of 80 patients per group. The investigators are therefore confident that the required case number of 45 per group will be reached.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast Track | – | –enhanced Recovery |
| standard therapy | – | –standard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hip arthroplasty elective
Key inclusion criteria (5 listed)
- Age ≥18 years
- The patient will undergo surgery at Klinikum rechts der Isar, Technical University of Munich (TUM)
- Written informed consent for participation in the study after detailed explanation of the nature, significance, risks and scope of the clinical trial
- Written informed consent from the patient for data collection and data processing, with the patient fully informed.
- Sufficient German language skills of the patient.
Key exclusion criteria (3 listed)
- Age < 18 years
- The patient is under guardianship, legally incapacitated or has limited legal capacity
- Only partial weight-bearing permitted
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
Hospital length of stay (days)
Time frame: From day of surgery until discharge, up to 4 days post-surgery
The total number of days a participant remains admitted in the hospital from the day of surgery until discharge. While the expected length of stay is approximately 4 days, some participants may stay longer depending on clinical needs.
Hip Disability and Osteoarthritis Outcome Score (HOOS)
Time frame: From baseline (pre-surgery) to 3 months post-surgery
The Hip Disability and Osteoarthritis Outcome Score (HOOS) is a validated, patient-reported instrument for assessing hip-related pain, function, and quality of life. Scores range from 0 to 100, with higher scores indicating better outcomes (less pain, better function, improved quality of life).
8 secondary outcomes
Timed Up and Go (TUG) Test
Time frame: From baseline (pre-surgery) to 3 months post-surgery
EQ-5D-5L (EuroQol 5 Dimensions, 5 Levels)
Time frame: From baseline (pre-surgery) to 3 months post-surgery
Range of Motion (ROM) - Neutral Zero Method (degrees)
Time frame: From baseline (pre-surgery) to 3 months post-surgery
Exercise Self-Efficacy Scale (ESES)
Time frame: From baseline (pre-surgery) to 3 months post-surgery
Pain Catastrophizing Scale (PCS)
Time frame: From baseline (pre-surgery) to 3 months post-surgery
Tampa Scale for Kinesiophobia (TSK)
Time frame: From baseline (pre-surgery) to 3 months post-surgery
Muscle Strength (Nm/kg body weight)
Time frame: From baseline (pre-surgery) to 3 months post-surgery
Physical Activity Enjoyment Scale (PACES)
Time frame: From baseline (pre-surgery) to 3 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Coxarthrosis
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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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.
Rüdiger von Eisenhart-Rothe, Prof. Dr. study director
Department of Orthopedics and Sports Orthopedics
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 Coxarthrosis, run by Technical University of Munich at 1 site in Germany.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Sep 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Vogel, Dr. (0049 41408917, Barbara.vogel@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (days) (time frame: From day of surgery until discharge, up to 4 days post-surgery). 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 30 Sep 2025.