Total Knee ArthroplastyNCT02120313
Inpatient Versus Outpatient Rehabilitation After TKA
A study testing inpatient rehabilitation and outpatient rehabilitation in people with Total Knee Arthroplasty, run by University of Rostock at 1 site in Germany.
Trial summary
The purpose of this study is to compare the effectiveness of inpatient and outpatient rehabilitation following total knee arthroplasty. No studies exist that have evaluated these two rehabilitation programmes in a specific orthopaedic patient population with a focus on motor performance. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- inpatient rehabilitation and outpatient rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Jun 2016
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with knee osteoarthritis and scheduled for primary TKA
- age: 50-80
Who cannot join
- BMI > 40
- musculoskeletal and neurological disorders that limit physical function
- any planned further joint surgery within 6 months
- substantial pain or functional limitation which make the patients unable to perform study procedures
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Orthopedics, University Medicine Rostock
Rostock, 18057
About this study
Official title: Inpatient Versus Outpatient Rehabilitation Following Total Knee Arthroplasty
The purpose of this study is to compare the effectiveness of inpatient and outpatient rehabilitation following total knee arthroplasty. No studies exist that have evaluated these two rehabilitation programmes in a specific orthopaedic patient population with a focus on motor performance. We hypothesized that patients participating in outpatient care tend to be physically more active than patients in the rehabilitation clinic, leading to the assumption that outpatient rehabilitation has superior functional outcomes compared to the inpatient standard-of-care therapy.
- Conditions
- Total Knee Arthroplasty
- Being tested
- inpatient rehabilitation, outpatient rehabilitation
- Keywords
- rehabilitation, total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inpatient rehabilitationOther
outpatient rehabilitationOther
| Study group | Role | What they receive |
|---|---|---|
| inpatient rehabilitation | Active comparator | After discharge, patients participate in daily physical therapy for 3 weeks in a rehabilitation hospital. Receives: Other: inpatient rehabilitation |
| outpatient rehabilitation | Experimental | After discharge, patients participate in daily physical therapy for 3 weeks in an outpatient rehabilitation center. Receives: Other: outpatient rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity (number of steps)
over a period of 7 days using activPAL activity recording system
Measured: during the first seven days of rehabilitation and 3 months post surgery (posttest)
Secondary outcomes (8)
gait performance
spatio-temporal and temprophasic gait parameters
Measured: posttest (3 months after surgery)
maximal active and passive knee joint range of motion
digital long-arm goniometer
Measured: change from baseline (9 days after surgery) to posttest (3 months after surgery)
stair climbing performance
stair climbing test
Measured: change from baseline (9 days after surgery) to posttest (3 months after surgery)
timed up and go performance
timed up and go test
Measured: change from baseline (9 days after surgery) to posttest (3 months after surgery)
joint position sense
The subjects' ability to actively reproduce a previously presented knee flexion angle (30° and 50° of knee Flexion)
Measured: change from baseline (9 days after surgery) to posttest (3 months after surgery)
knee pain
visual analogue scale
Measured: change from baseline (9 days after surgery) to posttest (3 months after surgery)
knee joint swelling
measurement of circumference
Measured: change from baseline (9 days after surgery) to posttest (3 months after surgery)
long-term Memory representation of the gait
structural dimensional analysis of mental representation (SDA-M)
Measured: change from baseline (9 days after surgery) to posttest (3 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 posted22 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anett Mau-Moeller, University of Rostock
- Investigators
- Philipp Bergschmidt, MD, Study chair, Department of Orthopedics, University Medicine RostockWolfram Mittelmeier, MD, Study director, Department of Orthopedics, University Medicine RostockAnett Mau-Moeller, M.A., Principal investigator, Department of Orthopedics, University Medicine RostockStephan Tohtz, MD, Principal investigator, Klinik für Orthopädie und Unfallchirurgie, HELIOS Klinikum Emil von Behring GmbHMartin Behrens, Principal investigator, Department of Kinesiology, University of RostockTino Stöckel, PhD, Principal investigator, Department of Kinesiology, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120313
- Sponsor's protocol ID
- ESAR
- Status last verified
- May 2017
- First submitted
- 17 Apr 2014
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Mau-Moeller A, El-Aarid N, Behrens M, Stockel T, Bergschmidt P, Bader R, Tohtz S, Mittelmeier W, Jacksteit R. Effectiveness of inpatient versus outpatient rehabilitation following total knee arthroplasty on clinical and functional outcomes in Germany: a non-randomized clinical trial. BMC Sports Sci Med Rehabil. 2026 May 23;18(1):248. doi: 10.1186/s13102-026-01735-4.
PubMed 42174717
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Versus Outpatient Rehabilitation Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02120313
- Acronym / sponsor ID
- ESAR
- Conditions
- Total Knee Arthroplasty
- Keywords
- rehabilitation, total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Apr 2014 (estimated)
- 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 purpose of this study is to compare the effectiveness of inpatient and outpatient rehabilitation following total knee arthroplasty. No studies exist that have evaluated these two rehabilitation programmes in a specific orthopaedic patient population with a focus on motor performance. We hypothesized that patients participating in outpatient care tend to be physically more active than patients in the rehabilitation clinic, leading to the assumption that outpatient rehabilitation has superior functional outcomes compared to the inpatient standard-of-care therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inpatient rehabilitation | Active comparator | Other: inpatient rehabilitationAfter discharge, patients participate in daily physical therapy for 3 weeks in a rehabilitation hospital. |
| outpatient rehabilitation | Experimental | Other: outpatient rehabilitationAfter discharge, patients participate in daily physical therapy for 3 weeks in an outpatient rehabilitation center. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with knee osteoarthritis and scheduled for primary TKA
- age: 50-80
Key exclusion criteria (4 listed)
- BMI > 40
- musculoskeletal and neurological disorders that limit physical function
- any planned further joint surgery within 6 months
- substantial pain or functional limitation which make the patients unable to perform study procedures
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 |
|---|---|---|
| inpatient rehabilitation | Other | inpatient rehabilitation |
| outpatient rehabilitation | Other | outpatient rehabilitation |
Primary outcome
physical activity (number of steps)
Time frame: during the first seven days of rehabilitation and 3 months post surgery (posttest)
over a period of 7 days using activPAL activity recording system
8 secondary outcomes
gait performance
Time frame: posttest (3 months after surgery)
maximal active and passive knee joint range of motion
Time frame: change from baseline (9 days after surgery) to posttest (3 months after surgery)
stair climbing performance
Time frame: change from baseline (9 days after surgery) to posttest (3 months after surgery)
timed up and go performance
Time frame: change from baseline (9 days after surgery) to posttest (3 months after surgery)
joint position sense
Time frame: change from baseline (9 days after surgery) to posttest (3 months after surgery)
knee pain
Time frame: change from baseline (9 days after surgery) to posttest (3 months after surgery)
knee joint swelling
Time frame: change from baseline (9 days after surgery) to posttest (3 months after surgery)
long-term Memory representation of the gait
Time frame: change from baseline (9 days after surgery) to posttest (3 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 23 May 2017.
- Derived from this study: PubMed 42174717Mau-Moeller A, El-Aarid N, Behrens M, Stockel T, Bergschmidt P, Bader R, Tohtz S, Mittelmeier W, Jacksteit R. Effectiveness of inpatient versus outpatient rehabilitation following total knee arthroplasty on clinical and functional outcomes in Germany: a non-randomized clinical trial. BMC Sports Sci Med Rehabil. 2026 May 23;18(1):248. doi: 10.1186/s13102-026-01735-4.
- Stiftung Oskar Helene HeimLink provided by the sponsor.
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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.
Philipp Bergschmidt, MD study chair
Department of Orthopedics, University Medicine Rostock
Wolfram Mittelmeier, MD study director
Department of Orthopedics, University Medicine Rostock
Anett Mau-Moeller, M.A. principal investigator
Department of Orthopedics, University Medicine Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inpatient rehabilitation and outpatient rehabilitation in people with Total Knee Arthroplasty, run by University of Rostock 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 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 23 May 2017. 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?
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?
physical activity (number of steps) (time frame: during the first seven days of rehabilitation and 3 months post surgery (posttest)). 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 NCT02120313, which also lists 1 linked publication.
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 23 May 2017.