Total Knee ReplacementNCT01463930
Audiovisual Videodisc Education and Modification of Expectations With Total Knee Replacement (TKR)
A study testing Educational audiovisual videodisc and medical verbal information and Medical verbal information in people with Total Knee Replacement, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
Information provided to patients modifies their expectations with surgery. The effects of preoperative audiovisual information on expectations with total knee replacement (TKR) have not been investigated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Educational audiovisual videodisc and medical verbal information and Medical verbal information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2009to Apr 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with knee osteoarthritis waiting for total knee replacement.
Who cannot join
- Cognitive disorders or language barriers precluding medical interview.
- Contralateral total knee replacement.
- History of revision total knee replacement.
- History of unicompartmental knee arthroplasty
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital de l'Esperança - Parc de Salut MAR
Barcelona, Barcelona, 08024
About this study
Official title: Effects of an Educational Audiovisual Videodisc on Patients' Pre-operative Expectations With Total Knee Replacement: a Randomized Study
Information provided to patients modifies their expectations with surgery. The effects of preoperative audiovisual information on expectations with total knee replacement (TKR) have not been investigated. The purposes of this study were to investigate the effectiveness of an educational videodisc on the modification of pre-operative patients' expectations with TKR and to find a biophysical profile of subjects in whom this videodisc could be most effective. It was hypothesized that patients receiving standard information plus additional medical information through audiovisual videodiscs would modify their pre-operative expectations more than those only receiving the standard information through medical interviews.
- Conditions
- Total Knee Replacement
- Being tested
- Educational audiovisual videodisc and medical verbal information, Medical verbal information
- Keywords
- Total Knee Replacement, Expectations, Audiovisual videodisc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational audiovisual videodisc and medical verbal informationBehavioural
General and specific medical verbal information and ten-minute DVD where the process from admission to the surgical intervention, recovery room, immediate postoperative care, and outpatient care at two, six, and twelve months after surgery was shown. The video included experiences of patients with respect to pain and function and examples of functionality during daily life activities such as stairs, kneeling or squatting. The video also demonstrated the facilities and rehabilitation techniques employed in the Physical Medicine and Rehabilitation Service.
Medical verbal informationBehavioural
General and specific verbal information provided by both the surgeon and a specialized nurse including basics of surgical technique, potential complications, and rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Audiovisual videodisc and medical verbal information | Experimental | Not described Receives: Behavioral: Educational audiovisual videodisc and medical verbal information |
| Medical verbal information | Active comparator | Not described Receives: Behavioral: Medical verbal information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in patient-reported postoperative expectatives about the results of total knee replacement to inmediately after receiving audiovisual plus verbal information (intervention grou) or only verbal information (control group)
The study measures the patient's expectatives about the improvement of pain, function, and psychological well-being after undergoing total knee replacement. These expectatives are measured through the Hospital for Special Surgery Knee Replacement Expectations Survey (KRES), and a score ranging from 0 to 100 is reported.
Measured: Baseline and 1 month later (1 month before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Leal Blanquet, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463930
- Sponsor's protocol ID
- PSMARCOT01_2011
- Status last verified
- Feb 2016
- First submitted
- 16 Oct 2011
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mancuso CA, Sculco TP, Wickiewicz TL, Jones EC, Robbins L, Warren RF, Williams-Russo P. Patients' expectations of knee surgery. J Bone Joint Surg Am. 2001 Jul;83(7):1005-12. doi: 10.2106/00004623-200107000-00005.
PubMed 11451969Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43. doi: 10.1097/01.blo.0000238825.63648.1e.
PubMed 16967035Hepinstall MS, Rutledge JR, Bornstein LJ, Mazumdar M, Westrich GH. Factors that impact expectations before total knee arthroplasty. J Arthroplasty. 2011 Sep;26(6):870-6. doi: 10.1016/j.arth.2010.09.010. Epub 2010 Nov 12.
PubMed 21074356Mancuso CA, Salvati EA, Johanson NA, Peterson MG, Charlson ME. Patients' expectations and satisfaction with total hip arthroplasty. J Arthroplasty. 1997 Jun;12(4):387-96. doi: 10.1016/s0883-5403(97)90194-7.
PubMed 9195314Nilsdotter AK, Toksvig-Larsen S, Roos EM. Knee arthroplasty: are patients' expectations fulfilled? A prospective study of pain and function in 102 patients with 5-year follow-up. Acta Orthop. 2009 Feb;80(1):55-61. doi: 10.1080/17453670902805007.
PubMed 19234886
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Educational Audiovisual Videodisc on Patients' Pre-operative Expectations With Total Knee Replacement: a Randomized Study
- ClinicalTrials.gov ID
- NCT01463930
- Acronym / sponsor ID
- PSMARCOT01_2011
- Conditions
- Total Knee Replacement
- Keywords
- Total Knee Replacement, Expectations, Audiovisual videodisc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 2 Nov 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.
Information provided to patients modifies their expectations with surgery. The effects of preoperative audiovisual information on expectations with total knee replacement (TKR) have not been investigated. The purposes of this study were to investigate the effectiveness of an educational videodisc on the modification of pre-operative patients' expectations with TKR and to find a biophysical profile of subjects in whom this videodisc could be most effective. It was hypothesized that patients receiving standard information plus additional medical information through audiovisual videodiscs would modify their pre-operative expectations more than those only receiving the standard information through medical interviews.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Audiovisual videodisc and medical verbal information | Experimental | Behavioral: Educational audiovisual videodisc and medical verbal information |
| Medical verbal information | Active comparator | Behavioral: Medical verbal information |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with knee osteoarthritis waiting for total knee replacement.
Key exclusion criteria (4 listed)
- Cognitive disorders or language barriers precluding medical interview.
- Contralateral total knee replacement.
- History of revision total knee replacement.
- History of unicompartmental knee arthroplasty
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 |
|---|---|---|
| Educational audiovisual videodisc and medical verbal informationGeneral and specific medical verbal information and ten-minute DVD where the process from admission to the surgical intervention, recovery room, immediate postoperative care, and outpatient care at two, six, and twelve months after surgery was shown. The video included experiences of patients with respect to pain and function and examples of functionality during daily life activities such as stairs, kneeling or squatting. The video also demonstrated the facilities and rehabilitation techniques employed in the Physical Medicine and Rehabilitation Service. | Behavioural | Audiovisual videodisc and medical verbal information |
| Medical verbal informationGeneral and specific verbal information provided by both the surgeon and a specialized nurse including basics of surgical technique, potential complications, and rehabilitation. | Behavioural | Medical verbal information |
Primary outcome
Change from baseline in patient-reported postoperative expectatives about the results of total knee replacement to inmediately after receiving audiovisual plus verbal information (intervention grou) or only verbal information (control group)
Time frame: Baseline and 1 month later (1 month before surgery)
The study measures the patient's expectatives about the improvement of pain, function, and psychological well-being after undergoing total knee replacement. These expectatives are measured through the Hospital for Special Surgery Knee Replacement Expectations Survey (KRES), and a score ranging from 0 to 100 is reported.
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 19 Feb 2016.
- Background: PubMed 11451969Mancuso CA, Sculco TP, Wickiewicz TL, Jones EC, Robbins L, Warren RF, Williams-Russo P. Patients' expectations of knee surgery. J Bone Joint Surg Am. 2001 Jul;83(7):1005-12. doi: 10.2106/00004623-200107000-00005.
- Background: PubMed 16967035Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43. doi: 10.1097/01.blo.0000238825.63648.1e.
- Background: PubMed 21074356Hepinstall MS, Rutledge JR, Bornstein LJ, Mazumdar M, Westrich GH. Factors that impact expectations before total knee arthroplasty. J Arthroplasty. 2011 Sep;26(6):870-6. doi: 10.1016/j.arth.2010.09.010. Epub 2010 Nov 12.
- Background: PubMed 9195314Mancuso CA, Salvati EA, Johanson NA, Peterson MG, Charlson ME. Patients' expectations and satisfaction with total hip arthroplasty. J Arthroplasty. 1997 Jun;12(4):387-96. doi: 10.1016/s0883-5403(97)90194-7.
- Background: PubMed 19234886Nilsdotter AK, Toksvig-Larsen S, Roos EM. Knee arthroplasty: are patients' expectations fulfilled? A prospective study of pain and function in 102 patients with 5-year follow-up. Acta Orthop. 2009 Feb;80(1):55-61. doi: 10.1080/17453670902805007.
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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.
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 Educational audiovisual videodisc and medical verbal information and Medical verbal information in people with Total Knee Replacement, run by Parc de Salut Mar at 1 site in Spain.
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: finished, as of the sponsor's last update on 19 Feb 2016. 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 Spain. 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?
Change from baseline in patient-reported postoperative expectatives about the results of total knee replacement to inmediately after receiving audiovisual plus verbal information (intervention grou) or only verbal information (control group) (time frame: Baseline and 1 month later (1 month before surgery)). 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 NCT01463930, which also lists 5 linked publications.
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 19 Feb 2016.