Hip OsteoarthritisRehab-hip-kneeNCT07105657
The Outcome of Three Weeks Rehabilitation in Patients With a Total Hip or Knee Replacement Experiencing Persistent Physical Impairments
An observational study of Hip Osteoarthritis and Knee Osteoarthristis, run by Horsens Hospital at 1 site in Denmark.
Trial summary
Patients with total hip or knee replacement experiencing persistant problems are offered 3 weeks of intensive rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Knee Osteoarthristis
- What is being tested?
- Rehabilitation
- How many people
- 84 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Aug 2025to 31 Dec 2027
- 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: Patients who have a total hip or knee replacement experiencing persistant problems, hence are admitted to a 3 week intensive rehabilitation period.
Who may be able to join
- Patients with a total hip or knee replacement admitted for intensive rehabilitation
Who cannot join
- Patients unable to understand Danish
- Unable to participate in physical tests
- Unable to understand questionaires
- Unable to participate i 6 months follow up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Horsens Regional Hospital
Brædstrup
Signe Kierkegaard-Brøchner, PhD, 004578427882, signkier@rm.dk
Signe Kierkegaard-Brøchner, PhD
About this study
Patients with total hip or knee replacement experiencing persistant problems are offered 3 weeks of intensive rehabilitation.
Read the detailed description
Outcomes before, at the end of treatment and at 6 months follow up will be investigated. Data will be handled separately for the two groups of patients: 42 with a total hip replacement and 42 with a total knee replacement. Specific and generic outcomes will be collected.
- Conditions
- Hip Osteoarthritis, Knee Osteoarthristis
- Being tested
- Rehabilitation
- Keywords
- total hip replacement, rehabilitation, hip osteoartritis, knee osteoarthritis, total knee replacement
- 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.
RehabilitationOther
Three weeks intensive rehabilitation where patients undergo group-based and individualised rehabilitation focusing at improving pain, function and quality of life for the patient
| Study group | Role | What they receive |
|---|---|---|
| Intervention group hip | Patients with a total hip replacement undergoing rehabilitation Receives: Other: Rehabilitation | |
| Intervention group knee | Patients with a total hip replacement undergoing rehabilitation Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOOS/KOOS pain (0-100 score)
Hip or knee related pain
Measured: Change from baseline (0) to 3 weeks
HOOS/KOOS ADL (0-100 score)
Hip or knee related activities of daily living
Measured: Change from baseline (0) to 3 weeks
HOOS/KOOS quality of life (0-100 score)
Hip or knee related quality of life
Measured: Change from baseline (0) to 3 weeks
HOOS/KOOS pain (0-100 score)
Hip or knee related pain
Measured: Change from 3 weeks to 7 months
HOOS/KOOS ADL (0-100 score)
Hip or knee related activities of daily living
Measured: Change from 3 weeks to 7 months
HOOS/KOOS quality of life (0-100 score)
Hip or knee related quality of life
Measured: Change from 3 weeks to 7 months
Sit-to-stand test
Number of completed sit to stands in 30 seconds
Measured: Change from baseline (0) to 3 weeks
Sit-to-stand test
Number of completed sit to stands in 30 seconds
Measured: Change from 3 weeks to 7 months
Secondary outcomes (21)
Patient acceptable symptom state (yes/no)
Patients are asked with a single question if their current symptom state is acceptable
Measured: 3 weeks follow up
Patient acceptable symptom state (yes/no)
Patients are asked with a single question if their current symptom state is acceptable
Measured: 7 months follow up
Pain catastrophising scale (0-52 score)
Current level of pain catastrophising with 0 being the best
Measured: Baseline
Pain catastrophising scale (0-52 score)
Current level of pain catastrophising with 0 being the best
Measured: 3 weeks
Pain catastrophising scale (0-52 score)
Current level of pain catastrophising with 0 being the best
Measured: 7 months
Global rating of change (0-11 score)
Likert scale where patients indicate their overall rating of change since the beginning of the intervention
Measured: Change from baseline to 3 weeks
Global rating of change (0-11 score)
Likert scale where patients indicate their overall rating of change since the beginning of the intervention
Measured: Change from baseline to 7 months
The 5-level EQ-5D version (EQ-5D-5L) (0-5 scale)
EQ5D5L scores
Measured: Change from baseline (0) to 3 weeks
The 5-level EQ-5D version (EQ-5D-5L) (0-5 scale)
EQ5D5L scores
Measured: Change from 3 weeks to 7 mothns
EQ5D VAS (0-100 scale)
EQ5D Vas overall health
Measured: Change from baseline (0) to 3 weeks
EQ5D VAS (0-100 scale)
EQ5D Vas overall health
Measured: Change from 3 weeks to 7 months
HOOS/KOOS symptoms (0-100 score)
Hip or knee related symptoms
Measured: Change from baseline (0) to 3 weeks
HOOS/KOOS symptoms (0-100 score)
Hip or knee symptoms
Measured: Change from 3 weeks to 7 months
HOOS/KOOS sport/rec (0-100 score)
Hip or knee related sport/rec
Measured: Change from baseline (0) to 3 weeks
HOOS/KOOS sport/rec (0-100 score)
Hip or knee related sport/rec
Measured: Change from 3 weeks to 7 months
6 minute walk test
The distance a patient can walk in 6 minutes
Measured: Change from baseline (0) to 3 weeks
6 minute walk test
The distance a patient can walk in 6 minutes
Measured: Change from 3 weeks to 7 months
40 meter fast paced walk test
The time a patient uses walking 40 meters fast
Measured: Change from baseline (0) to 3 weeks
40 meter fast paced walk test
The time a patient uses walking 40 meters fast
Measured: Change from 3 weeks to 7 months
Stair test
The time a patient uses to ascend and decend a staircase
Measured: Change from baseline (0) to 3 weeks
Stair test
The time a patient uses to ascend and decend a staircase
Measured: Change from 3 weeks to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start25 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horsens Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- VIA University College
- Responsible party
- Principal investigator, Jeppe Lange, Horsens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105657
- Sponsor's protocol ID
- 1-16-02-329-25
- Acronym
- Rehab-hip-knee
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome of Three Weeks Rehabilitation in Patients With a Total Hip or Knee Replacement Experiencing Persistent Physical Impairments
- ClinicalTrials.gov ID
- NCT07105657
- Acronym / sponsor ID
- Rehab-hip-knee / 1-16-02-329-25
- Conditions
- Hip Osteoarthritis, Knee Osteoarthristis
- Keywords
- total hip replacement, rehabilitation, hip osteoartritis, knee osteoarthritis, total knee replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Horsens HospitalUniversity, hospital or other
- Collaborators
- VIA University College
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Aug 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.
Patients with total hip or knee replacement experiencing persistant problems are offered 3 weeks of intensive rehabilitation.
Detailed description
Outcomes before, at the end of treatment and at 6 months follow up will be investigated. Data will be handled separately for the two groups of patients: 42 with a total hip replacement and 42 with a total knee replacement. Specific and generic outcomes will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group hip | – | Other: RehabilitationPatients with a total hip replacement undergoing rehabilitation |
| Intervention group knee | – | Other: RehabilitationPatients with a total hip replacement undergoing rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have a total hip or knee replacement experiencing persistant problems, hence are admitted to a 3 week intensive rehabilitation period.
Key inclusion criteria (1 listed)
- Patients with a total hip or knee replacement admitted for intensive rehabilitation
Key exclusion criteria (4 listed)
- Patients unable to understand Danish
- Unable to participate in physical tests
- Unable to understand questionaires
- Unable to participate i 6 months follow up
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 |
|---|---|---|
| RehabilitationThree weeks intensive rehabilitation where patients undergo group-based and individualised rehabilitation focusing at improving pain, function and quality of life for the patient | Other | Intervention group hip, Intervention group knee |
Primary outcome
HOOS/KOOS pain (0-100 score)
Time frame: Change from baseline (0) to 3 weeks
Hip or knee related pain
HOOS/KOOS ADL (0-100 score)
Time frame: Change from baseline (0) to 3 weeks
Hip or knee related activities of daily living
HOOS/KOOS quality of life (0-100 score)
Time frame: Change from baseline (0) to 3 weeks
Hip or knee related quality of life
HOOS/KOOS pain (0-100 score)
Time frame: Change from 3 weeks to 7 months
Hip or knee related pain
HOOS/KOOS ADL (0-100 score)
Time frame: Change from 3 weeks to 7 months
Hip or knee related activities of daily living
HOOS/KOOS quality of life (0-100 score)
Time frame: Change from 3 weeks to 7 months
Hip or knee related quality of life
Sit-to-stand test
Time frame: Change from baseline (0) to 3 weeks
Number of completed sit to stands in 30 seconds
Sit-to-stand test
Time frame: Change from 3 weeks to 7 months
Number of completed sit to stands in 30 seconds
21 secondary outcomes
Patient acceptable symptom state (yes/no)
Time frame: 3 weeks follow up
Patient acceptable symptom state (yes/no)
Time frame: 7 months follow up
Pain catastrophising scale (0-52 score)
Time frame: Baseline
Pain catastrophising scale (0-52 score)
Time frame: 3 weeks
Pain catastrophising scale (0-52 score)
Time frame: 7 months
Global rating of change (0-11 score)
Time frame: Change from baseline to 3 weeks
Global rating of change (0-11 score)
Time frame: Change from baseline to 7 months
The 5-level EQ-5D version (EQ-5D-5L) (0-5 scale)
Time frame: Change from baseline (0) to 3 weeks
The 5-level EQ-5D version (EQ-5D-5L) (0-5 scale)
Time frame: Change from 3 weeks to 7 mothns
EQ5D VAS (0-100 scale)
Time frame: Change from baseline (0) to 3 weeks
EQ5D VAS (0-100 scale)
Time frame: Change from 3 weeks to 7 months
HOOS/KOOS symptoms (0-100 score)
Time frame: Change from baseline (0) to 3 weeks
HOOS/KOOS symptoms (0-100 score)
Time frame: Change from 3 weeks to 7 months
HOOS/KOOS sport/rec (0-100 score)
Time frame: Change from baseline (0) to 3 weeks
HOOS/KOOS sport/rec (0-100 score)
Time frame: Change from 3 weeks to 7 months
6 minute walk test
Time frame: Change from baseline (0) to 3 weeks
6 minute walk test
Time frame: Change from 3 weeks to 7 months
40 meter fast paced walk test
Time frame: Change from baseline (0) to 3 weeks
40 meter fast paced walk test
Time frame: Change from 3 weeks to 7 months
Stair test
Time frame: Change from baseline (0) to 3 weeks
Stair test
Time frame: Change from 3 weeks to 7 months
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 26 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Osteoarthristis, run by Horsens Hospital at 1 site in Denmark.
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 1 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: looking for participants now, as of the sponsor's last update on 26 Aug 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 Denmark. 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 Signe Kierkegaard-Brøchner, PhD (004578427882, signkier@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOOS/KOOS pain (0-100 score) (time frame: Change from baseline (0) to 3 weeks). The study lists 8 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 26 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.