Knee ArthroplastyHOLESTNCT01329081
Rehabilitation After Fast-track Total Knee Arthroplasty
A study testing Postoperative rehabilitation after fast-track TKA in people with Knee Arthroplasty, run by University of Aarhus at 1 site in Denmark.
Trial summary
BACKGROUND In 2008 approximately 7,700 total knee arthroplasties (TKA) were performed in Denmark. The results after TKA is in general very good, the investigators have, however, discovered that patients following fast-track TKA still have a deficit 12 months postoperatively of 5-10% in health-related quality-of-life… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Postoperative rehabilitation after fast-track TKA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Start not givento not given
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age above 18 years
- patients diagnosed as having knee arthrosis
- patients receiving primary elective TKA and
- patients who are able to and willing transport themselves to the rehabilitation center, which demands ability to walk 50 meter, and climb 10 stair steps
Who cannot join
- unicompartmental or revision arthroplasty
- any neurological disease
- knee infection and
- substantial pain or functional limitation hindering rehabilitation tested by physiotherapist prior to rehabilitation start
Trial locations and contacts
1 site in 1 country.
About this study
BACKGROUND In 2008 approximately 7,700 total knee arthroplasties (TKA) were performed in Denmark. The results after TKA is in general very good, the investigators have, however, discovered that patients following fast-track TKA still have a deficit 12 months postoperatively of 5-10% in health-related quality-of-life and 15-20% in activity and participation when compared to age- and gender matched population. A postoperative rehabilitation intervention has the potential to reduce or remove this observed deficit. The current evidence of postoperative rehabilitation after TKA is, however, scares and conflicting, and no studies have shown a lasting effect beyond 3 months postoperatively.
PURPOSE The purpose of this study is to investigate if a 6-weeks postoperative rehabilitation intervention is more effective than supervised home training, and furthermore to investigate the cost-effectiveness of the intervention in a societal perspective.
MATERIALS \& METHODS The study is performed as a randomized clinical trial. In total 140 patients are included in the study. Inclusion criteria are age above 18 years, patients diagnosed as having knee arthrosis, patients receiving primary elective TKA, and patients who are able to and willing transport themselves to the rehabilitation center, which demands ability to walk 50 meter, and climb 10 stair steps. Exclusion criteria are unicompartmental or revision arthroplasty, any neurological disease, knee infection, and substantial pain or functional limitation hindering rehabilitation tested by physiotherapist prior to rehabilitation start. Primary endpoint is 6 months postoperatively and primary outcome measure is change in total score by using the knee specific questionnaire Oxford Knee Score.
- Conditions
- Knee Arthroplasty
- Being tested
- Postoperative rehabilitation after fast-track TKA
- Keywords
- Rehabilitation, Strength training, Long-term effect, Activity and participation after fast-track knee arthroplasty
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative rehabilitation after fast-track TKAOther
Also called Rehabilitation, Strength, Patient education
Six weeks of strength training combined with patient education
Postoperative rehabilitation after fast-track TKAOther
Six to eight weeks of supervised home training
| Study group | Role | What they receive |
|---|---|---|
| Six weeks strength training in teams and patient education | Experimental | Not described Receives: Other: Postoperative rehabilitation after fast-track TKA |
| Supervised home training with focus on activities | Experimental | Not described Receives: Other: Postoperative rehabilitation after fast-track TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score
A disease specific questionnaire, which measures knee pain and function with 12 items. The questionnaire is sum scored with a range from 0 = worse pain and function to 48 = best pain and function
Measured: Six months postoperatively
Secondary outcomes (1)
EQ-5D
A generic questionnaire, which measures health-related quality-of-life (HRQOL) with 5 items. The questionnaire is scored with a range from -0.55 = worse HRQOL to 1.00 = best HRQOL
Measured: Twelve months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329081
- Sponsor's protocol ID
- KL24621
- Acronym
- HOLEST
- Status last verified
- Dec 2022
- First submitted
- 27 Apr 2010
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation After Fast-track Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01329081
- Acronym / sponsor ID
- HOLEST / KL24621
- Conditions
- Knee Arthroplasty
- Keywords
- Rehabilitation, Strength training, Long-term effect, Activity and participation after fast-track knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- First posted
- 5 Apr 2011 (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.
BACKGROUND In 2008 approximately 7,700 total knee arthroplasties (TKA) were performed in Denmark. The results after TKA is in general very good, the investigators have, however, discovered that patients following fast-track TKA still have a deficit 12 months postoperatively of 5-10% in health-related quality-of-life and 15-20% in activity and participation when compared to age- and gender matched population. A postoperative rehabilitation intervention has the potential to reduce or remove this observed deficit. The current evidence of postoperative rehabilitation after TKA is, however, scares and conflicting, and no studies have shown a lasting effect beyond 3 months postoperatively.
PURPOSE The purpose of this study is to investigate if a 6-weeks postoperative rehabilitation intervention is more effective than supervised home training, and furthermore to investigate the cost-effectiveness of the intervention in a societal perspective.
MATERIALS \& METHODS The study is performed as a randomized clinical trial. In total 140 patients are included in the study. Inclusion criteria are age above 18 years, patients diagnosed as having knee arthrosis, patients receiving primary elective TKA, and patients who are able to and willing transport themselves to the rehabilitation center, which demands ability to walk 50 meter, and climb 10 stair steps. Exclusion criteria are unicompartmental or revision arthroplasty, any neurological disease, knee infection, and substantial pain or functional limitation hindering rehabilitation tested by physiotherapist prior to rehabilitation start. Primary endpoint is 6 months postoperatively and primary outcome measure is change in total score by using the knee specific questionnaire Oxford Knee Score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Six weeks strength training in teams and patient education | Experimental | Other: Postoperative rehabilitation after fast-track TKA |
| Supervised home training with focus on activities | Experimental | Other: Postoperative rehabilitation after fast-track TKA |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age above 18 years
- patients diagnosed as having knee arthrosis
- patients receiving primary elective TKA and
- patients who are able to and willing transport themselves to the rehabilitation center, which demands ability to walk 50 meter, and climb 10 stair steps
Key exclusion criteria (4 listed)
- unicompartmental or revision arthroplasty
- any neurological disease
- knee infection and
- substantial pain or functional limitation hindering rehabilitation tested by physiotherapist prior to rehabilitation start
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 |
|---|---|---|
| Postoperative rehabilitation after fast-track TKAAlso: Rehabilitation, Strength, Patient educationSix weeks of strength training combined with patient education | Other | Six weeks strength training in teams and patient education |
| Postoperative rehabilitation after fast-track TKASix to eight weeks of supervised home training | Other | Supervised home training with focus on activities |
Primary outcome
Oxford Knee Score
Time frame: Six months postoperatively
A disease specific questionnaire, which measures knee pain and function with 12 items. The questionnaire is sum scored with a range from 0 = worse pain and function to 48 = best pain and function
1 secondary outcome
EQ-5D
Time frame: Twelve months postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
Related trials for Knee Arthroplasty
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative rehabilitation after fast-track TKA in people with Knee Arthroplasty, run by University of Aarhus 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 4 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: withdrawn, as of the sponsor's last update on 23 Dec 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Oxford Knee Score (time frame: Six months postoperatively). 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 23 Dec 2022.