Musculoskeletal DisordersNCT06735547
Effectiveness of a Mobile Telerehabilitation Tool Versus Conventional Treatment in Total Knee Arthroplasty
A study testing Telerehabilitation and Conventional therapy group in people with Musculoskeletal Disorders and Knee Osteoarthritis (OA), run by Sanitas University at 1 site in Colombia.
Trial summary
Knee arthroplasty is one of the most common surgical procedures, and early rehabilitation is essential for patient recovery, pain modulation and a faster reintegration into daily life activities. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Musculoskeletal Disorders, Knee Osteoarthritis (OA)
- What is being tested?
- Telerehabilitation and Conventional therapy group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteColombia
- Study dates
- 1 Dec 2023to 10 Oct 2024
- 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 diagnosed with degenerative osteoarthritis with an indication for primary Total Knee Replacement (TKR) surgery at Clínica Universitaria Colombia or Central de Urgencias de Puente Aranda.
- Patients in the postoperative period following primary outpatient TKR.
- Patients with functional independence.
- Patients who agree to participate in the study and sign the informed consent form.
- Patients with access to a mobile device, tablet, computer, with internet access and the ability to operate it.
- Patients who have an appropriate space to perform therapy at home.
- Patients who will be accompanied during therapy sessions at home.
Who cannot join
- ASA Class IV (American Society of Anesthesiologists)
- BMI > 35
- Dementia and cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Mobile Telerehabilitation Tool Versus Conventional Treatment in Total Knee Arthroplasty: a Controlled Clinical Trial
Knee arthroplasty is one of the most common surgical procedures, and early rehabilitation is essential for patient recovery, pain modulation and a faster reintegration into daily life activities. However, it has been reported that the percentage of patients who continue rehabilitation for the time required to achieve these outcomes is much lower than those who abandon therapy. This is often due to various factors such as office hours, difficult access to appointments, and sometimes insufficient infrastructure and personnel to meet the demand. Currently, due to the global situation, it is crucial to conduct these rehabilitation processes remotely and virtually, making use of various technological tools that enable patients to interact with the healthcare professionals in charge of their rehabilitation. Among these tools are mobile applications on smartphones, which not only facilitate proper physical preparation, but also offer valuable real-time feedback. Furthermore, 8% of the total cost of knee joint replacements corresponds to the rehabilitation program. These costs are significantly reduced with telerehabilitation assisted by mobile tools, which not only improves patient access but also increases adherence and satisfaction levels by allowing the customization of rehabilitation programs based on each patient's specific needs and characteristics. The aim of this study is to evaluate the effectiveness outcomes of an artificial intelligence-guided mobile tool versus conventional rehabilitation during the first three months postoperatively following total knee replacement.
Read the detailed description
A parallel, controlled randomized clinical trial will be conducted. Study Population: Patients with knee osteoarthritis undergoing primary total knee replacement (TKR) at Clínica Universitaria Colombia and Puente Aranda Emergency Center, whose postoperative follow-up is ambulatory, and who meets the inclusion criteria.
Outcomes: Functionality will be the primary outcome, measured in terms of the WOMAC score, knee range of movement, and pain, by means of the visual analogue scale. Adherence to treatment, number of therapy sessions, patient satisfaction, and the presence of adverse events will also be measured.
- Being tested
- Telerehabilitation, Conventional therapy group
- Keywords
- Knee replacement arthroplasty, Telerehabilitation, Mobile applications, Artificial intelligence, Outpatient management
- Medical subject headings
- Musculoskeletal Diseases, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationDevice
Patients in the Telerehabilitation group will perform an average of three therapy sessions per week, with data collected and monitored by TRAK's physiotherapists. Both groups will have their results measured monthly by the orthopedic surgeons for 12 weeks (3 months) postoperatively.
Conventional therapy groupOther
Patients in the conventional group will be assessed by a professional physiotherapist, scheduling appointments according to their own preferences and disponibility. Both groups will have their results measured monthly by the orthopedic surgeons for 12 weeks (3 months) postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Patients will receive telerehabilitation by means of the TRAK mobile tool, collecting data and allowing them to monitor their activity through ROM during exercises (bio-feedback). Receives: Device: Telerehabilitation |
| Conventional Therapy | Active comparator | Patients will be assessed by a professional physiotherapist, who will monitor their progress, by measuring range of motion (ROM), and stability, making corrections if necessary. Receives: Other: Conventional therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Range of Motion
Measurement of knee joint range of motion in flexion and extension using a goniometer from preoperative follow-up to the third month postoperatively.
Measured: Measurement will be performed before surgery (at the preoperative visit) and monthly during the first three months of the postoperative period (ending at 3 months postoperatively).
Functionality - WOMAC survey
WOMAC survey, validated in Colombia with a numerical result from 0 to 96, carried out during the preoperative visit until the third postoperative month.
Measured: Measurement will be performed before surgery (at the preoperative visit) and monthly during the first three months of the postoperative period (ending at 3 months postoperatively).
Functionality - Get Up and Go
Test that measures the time required to get up from the chair, walk to the mark 3 meters away, turn around and sit back in the chair, measured from preoperative follow-up to the third month postoperatively.
Measured: Measurement will be performed before surgery (at the preoperative visit) and monthly during the first three months of the postoperative period (ending at 3 months postoperatively).
Pain - Visual Analogue Scale
Measurement of the patient's subjective perception of pain in a written survey and scale from 0 to 10.
Measured: Measured from day 0 every 24 hours until day 14 postoperatively.
Secondary outcomes (5)
Number of therapy sessions
Number of face-to-face physical therapy sessions or TRAK therapy sessions.
Measured: From the beginning of rehabilitation until the third postoperative month.
Percentage of Adherence
Percentage of adherence to the prescribed rehabilitation program.
Measured: From the beginning of rehabilitation until the third postoperative month.
Patient Satisfaction
Measuring patient satisfaction with the prescribed rehabilitation program through a question with the option to respond: completely satisfied, satisfied, neither satisfied nor dissatisfied, somewhat satisfied, and not at all satisfied
Measured: Measured at the end of rehabilitation, 3 months postoperatively
Surgery Complications
Complications derived from the surgical procedure: Material Failure, Dislocation, Fracture, Wound Dehiscence, Rigidity, Readmission, Death, Need for mobilization under anesthesia
Measured: Measured from the start of surgery to the third month postoperatively.
Therapy Adverse Events
Adverse events that occurred during the prescribed therapy sessions: Fall, Wound Dehiscence, Fracture, Ecchymosis, Ligament Injury, Need for intervention, Hematoma, Other
Measured: Measured from the start of the postoperative period to the third postoperative month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Dec 2023
- Primary completion30 Mar 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DisordersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanitas University
- Sponsor type
- University, hospital or other
- Collaborators
- Biokeralty Research Institute
- Responsible party
- Principal investigator, Claudia Aristizábal, Sanitas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735547
- Sponsor's protocol ID
- 102-22UNV
- Status last verified
- Oct 2024
- First submitted
- 18 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pellegrini CA, Lee J, DeVivo KE, Harpine CE, Del Gaizo DJ, Wilcox S. Reducing sedentary time using an innovative mHealth intervention among patients with total knee replacement: Rationale and study protocol. Contemp Clin Trials Commun. 2021 Jun 18;22:100810. doi: 10.1016/j.conctc.2021.100810. eCollection 2021 Jun.
PubMed 34195473Eichler S, Rabe S, Salzwedel A, Muller S, Stoll J, Tilgner N, John M, Wegscheider K, Mayer F, Voller H; ReMove-It study group. Effectiveness of an interactive telerehabilitation system with home-based exercise training in patients after total hip or knee replacement: study protocol for a multicenter, superiority, no-blinded randomized controlled trial. Trials. 2017 Sep 21;18(1):438. doi: 10.1186/s13063-017-2173-3.
PubMed 28934966Khan F, Ng L, Gonzalez S, Hale T, Turner-Stokes L. Multidisciplinary rehabilitation programmes following joint replacement at the hip and knee in chronic arthropathy. Cochrane Database Syst Rev. 2008 Apr 16;2008(2):CD004957. doi: 10.1002/14651858.CD004957.pub3.
PubMed 18425906Muller M, Toussaint R, Kohlmann T. [Total hip and knee arthroplasty : Results of outpatient orthopedic rehabilitation]. Orthopade. 2015 Mar;44(3):203-11. doi: 10.1007/s00132-014-3000-0. German.
PubMed 25209014Callejas-Cuervo M, Gutierrez RM, Hernandez AI. Joint amplitude MEMS based measurement platform for low cost and high accessibility telerehabilitation: Elbow case study. J Bodyw Mov Ther. 2017 Jul;21(3):574-581. doi: 10.1016/j.jbmt.2016.08.016. Epub 2016 Sep 9.
PubMed 28750967van Egmond MA, van der Schaaf M, Vredeveld T, Vollenbroek-Hutten MMR, van Berge Henegouwen MI, Klinkenbijl JHG, Engelbert RHH. Effectiveness of physiotherapy with telerehabilitation in surgical patients: a systematic review and meta-analysis. Physiotherapy. 2018 Sep;104(3):277-298. doi: 10.1016/j.physio.2018.04.004. Epub 2018 Jun 19.
PubMed 30030037Backer HC, Wu CH, Schulz MRG, Weber-Spickschen TS, Perka C, Hardt S. App-based rehabilitation program after total knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2021 Sep;141(9):1575-1582. doi: 10.1007/s00402-021-03789-0. Epub 2021 Feb 6.
PubMed 33547927Tripuraneni KR, Foran JRH, Munson NR, Racca NE, Carothers JT. A Smartwatch Paired With A Mobile Application Provides Postoperative Self-Directed Rehabilitation Without Compromising Total Knee Arthroplasty Outcomes: A Randomized Controlled Trial. J Arthroplasty. 2021 Dec;36(12):3888-3893. doi: 10.1016/j.arth.2021.08.007. Epub 2021 Aug 9.
PubMed 34462184Henderson KG, Wallis JA, Snowdon DA. Active physiotherapy interventions following total knee arthroplasty in the hospital and inpatient rehabilitation settings: a systematic review and meta-analysis. Physiotherapy. 2018 Mar;104(1):25-35. doi: 10.1016/j.physio.2017.01.002. Epub 2017 Feb 1.
PubMed 28802773Masaracchio M, Hanney WJ, Liu X, Kolber M, Kirker K. Timing of rehabilitation on length of stay and cost in patients with hip or knee joint arthroplasty: A systematic review with meta-analysis. PLoS One. 2017 Jun 2;12(6):e0178295. doi: 10.1371/journal.pone.0178295. eCollection 2017.
PubMed 28575058Hsu H, Siwiec RM. Knee Osteoarthritis. StatPearls. Treasure Island (FL). 2024. Available from: https://www.ncbi.nlm.nih.gov/books/NBK507884/
Jiang S, Xiang J, Gao X, Guo K, Liu B. The comparison of telerehabilitation and face-to-face rehabilitation after total knee arthroplasty: A systematic review and meta-analysis. J Telemed Telecare. 2018 May;24(4):257-262. doi: 10.1177/1357633X16686748. Epub 2016 Dec 27.
PubMed 28027679
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mobile Telerehabilitation Tool Versus Conventional Treatment in Total Knee Arthroplasty: a Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06735547
- Acronym / sponsor ID
- 102-22UNV
- Keywords
- Knee replacement arthroplasty, Telerehabilitation, Mobile applications, Artificial intelligence, Outpatient management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Sanitas UniversityUniversity, hospital or other
- Collaborators
- Biokeralty Research Institute
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 16 Dec 2024 (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.
Knee arthroplasty is one of the most common surgical procedures, and early rehabilitation is essential for patient recovery, pain modulation and a faster reintegration into daily life activities. However, it has been reported that the percentage of patients who continue rehabilitation for the time required to achieve these outcomes is much lower than those who abandon therapy. This is often due to various factors such as office hours, difficult access to appointments, and sometimes insufficient infrastructure and personnel to meet the demand. Currently, due to the global situation, it is crucial to conduct these rehabilitation processes remotely and virtually, making use of various technological tools that enable patients to interact with the healthcare professionals in charge of their rehabilitation. Among these tools are mobile applications on smartphones, which not only facilitate proper physical preparation, but also offer valuable real-time feedback. Furthermore, 8% of the total cost of knee joint replacements corresponds to the rehabilitation program. These costs are significantly reduced with telerehabilitation assisted by mobile tools, which not only improves patient access but also increases adherence and satisfaction levels by allowing the customization of rehabilitation programs based on each patient's specific needs and characteristics. The aim of this study is to evaluate the effectiveness outcomes of an artificial intelligence-guided mobile tool versus conventional rehabilitation during the first three months postoperatively following total knee replacement.
Detailed description
A parallel, controlled randomized clinical trial will be conducted. Study Population: Patients with knee osteoarthritis undergoing primary total knee replacement (TKR) at Clínica Universitaria Colombia and Puente Aranda Emergency Center, whose postoperative follow-up is ambulatory, and who meets the inclusion criteria.
Outcomes: Functionality will be the primary outcome, measured in terms of the WOMAC score, knee range of movement, and pain, by means of the visual analogue scale. Adherence to treatment, number of therapy sessions, patient satisfaction, and the presence of adverse events will also be measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Device: TelerehabilitationPatients will receive telerehabilitation by means of the TRAK mobile tool, collecting data and allowing them to monitor their activity through ROM during exercises (bio-feedback). |
| Conventional Therapy | Active comparator | Other: Conventional therapy groupPatients will be assessed by a professional physiotherapist, who will monitor their progress, by measuring range of motion (ROM), and stability, making corrections if necessary. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients diagnosed with degenerative osteoarthritis with an indication for primary Total Knee Replacement (TKR) surgery at Clínica Universitaria Colombia or Central de Urgencias de Puente Aranda.
- Patients in the postoperative period following primary outpatient TKR.
- Patients with functional independence.
- Patients who agree to participate in the study and sign the informed consent form.
- Patients with access to a mobile device, tablet, computer, with internet access and the ability to operate it.
Key exclusion criteria (3 listed)
- ASA Class IV (American Society of Anesthesiologists)
- BMI > 35
- Dementia and cognitive impairment
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 |
|---|---|---|
| TelerehabilitationPatients in the Telerehabilitation group will perform an average of three therapy sessions per week, with data collected and monitored by TRAK's physiotherapists. Both groups will have their results measured monthly by the orthopedic surgeons for 12 weeks (3 months) postoperatively. | Device | Telerehabilitation |
| Conventional therapy groupPatients in the conventional group will be assessed by a professional physiotherapist, scheduling appointments according to their own preferences and disponibility. Both groups will have their results measured monthly by the orthopedic surgeons for 12 weeks (3 months) postoperatively. | Other | Conventional Therapy |
Primary outcome
Knee Range of Motion
Time frame: Measurement will be performed before surgery (at the preoperative visit) and monthly during the first three months of the postoperative period (ending at 3 months postoperatively).
Measurement of knee joint range of motion in flexion and extension using a goniometer from preoperative follow-up to the third month postoperatively.
Functionality - WOMAC survey
Time frame: Measurement will be performed before surgery (at the preoperative visit) and monthly during the first three months of the postoperative period (ending at 3 months postoperatively).
WOMAC survey, validated in Colombia with a numerical result from 0 to 96, carried out during the preoperative visit until the third postoperative month.
Functionality - Get Up and Go
Time frame: Measurement will be performed before surgery (at the preoperative visit) and monthly during the first three months of the postoperative period (ending at 3 months postoperatively).
Test that measures the time required to get up from the chair, walk to the mark 3 meters away, turn around and sit back in the chair, measured from preoperative follow-up to the third month postoperatively.
Pain - Visual Analogue Scale
Time frame: Measured from day 0 every 24 hours until day 14 postoperatively.
Measurement of the patient's subjective perception of pain in a written survey and scale from 0 to 10.
5 secondary outcomes
Number of therapy sessions
Time frame: From the beginning of rehabilitation until the third postoperative month.
Percentage of Adherence
Time frame: From the beginning of rehabilitation until the third postoperative month.
Patient Satisfaction
Time frame: Measured at the end of rehabilitation, 3 months postoperatively
Surgery Complications
Time frame: Measured from the start of surgery to the third month postoperatively.
Therapy Adverse Events
Time frame: Measured from the start of the postoperative period to the third postoperative month.
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 16 Dec 2024.
- Background: PubMed 34195473Pellegrini CA, Lee J, DeVivo KE, Harpine CE, Del Gaizo DJ, Wilcox S. Reducing sedentary time using an innovative mHealth intervention among patients with total knee replacement: Rationale and study protocol. Contemp Clin Trials Commun. 2021 Jun 18;22:100810. doi: 10.1016/j.conctc.2021.100810. eCollection 2021 Jun.
- Background: PubMed 28934966Eichler S, Rabe S, Salzwedel A, Muller S, Stoll J, Tilgner N, John M, Wegscheider K, Mayer F, Voller H; ReMove-It study group. Effectiveness of an interactive telerehabilitation system with home-based exercise training in patients after total hip or knee replacement: study protocol for a multicenter, superiority, no-blinded randomized controlled trial. Trials. 2017 Sep 21;18(1):438. doi: 10.1186/s13063-017-2173-3.
- Background: PubMed 18425906Khan F, Ng L, Gonzalez S, Hale T, Turner-Stokes L. Multidisciplinary rehabilitation programmes following joint replacement at the hip and knee in chronic arthropathy. Cochrane Database Syst Rev. 2008 Apr 16;2008(2):CD004957. doi: 10.1002/14651858.CD004957.pub3.
- Background: PubMed 25209014Muller M, Toussaint R, Kohlmann T. [Total hip and knee arthroplasty : Results of outpatient orthopedic rehabilitation]. Orthopade. 2015 Mar;44(3):203-11. doi: 10.1007/s00132-014-3000-0. German.
- Background: PubMed 28750967Callejas-Cuervo M, Gutierrez RM, Hernandez AI. Joint amplitude MEMS based measurement platform for low cost and high accessibility telerehabilitation: Elbow case study. J Bodyw Mov Ther. 2017 Jul;21(3):574-581. doi: 10.1016/j.jbmt.2016.08.016. Epub 2016 Sep 9.
- Background: PubMed 30030037van Egmond MA, van der Schaaf M, Vredeveld T, Vollenbroek-Hutten MMR, van Berge Henegouwen MI, Klinkenbijl JHG, Engelbert RHH. Effectiveness of physiotherapy with telerehabilitation in surgical patients: a systematic review and meta-analysis. Physiotherapy. 2018 Sep;104(3):277-298. doi: 10.1016/j.physio.2018.04.004. Epub 2018 Jun 19.
- Background: PubMed 33547927Backer HC, Wu CH, Schulz MRG, Weber-Spickschen TS, Perka C, Hardt S. App-based rehabilitation program after total knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2021 Sep;141(9):1575-1582. doi: 10.1007/s00402-021-03789-0. Epub 2021 Feb 6.
- Background: PubMed 34462184Tripuraneni KR, Foran JRH, Munson NR, Racca NE, Carothers JT. A Smartwatch Paired With A Mobile Application Provides Postoperative Self-Directed Rehabilitation Without Compromising Total Knee Arthroplasty Outcomes: A Randomized Controlled Trial. J Arthroplasty. 2021 Dec;36(12):3888-3893. doi: 10.1016/j.arth.2021.08.007. Epub 2021 Aug 9.
- Background: PubMed 28802773Henderson KG, Wallis JA, Snowdon DA. Active physiotherapy interventions following total knee arthroplasty in the hospital and inpatient rehabilitation settings: a systematic review and meta-analysis. Physiotherapy. 2018 Mar;104(1):25-35. doi: 10.1016/j.physio.2017.01.002. Epub 2017 Feb 1.
- Background: PubMed 28575058Masaracchio M, Hanney WJ, Liu X, Kolber M, Kirker K. Timing of rehabilitation on length of stay and cost in patients with hip or knee joint arthroplasty: A systematic review with meta-analysis. PLoS One. 2017 Jun 2;12(6):e0178295. doi: 10.1371/journal.pone.0178295. eCollection 2017.
- BackgroundHsu H, Siwiec RM. Knee Osteoarthritis. StatPearls. Treasure Island (FL). 2024. Available from: https://www.ncbi.nlm.nih.gov/books/NBK507884/
- Background: PubMed 28027679Jiang S, Xiang J, Gao X, Guo K, Liu B. The comparison of telerehabilitation and face-to-face rehabilitation after total knee arthroplasty: A systematic review and meta-analysis. J Telemed Telecare. 2018 May;24(4):257-262. doi: 10.1177/1357633X16686748. Epub 2016 Dec 27.
- Individual participant dataSharing planned: No
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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 Telerehabilitation and Conventional therapy group in people with Musculoskeletal Disorders and Knee Osteoarthritis (OA), run by Sanitas University at 1 site in Colombia.
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 7 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: finished, as of the sponsor's last update on 16 Dec 2024. 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 Colombia. 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?
Knee Range of Motion (time frame: Measurement will be performed before surgery (at the preoperative visit) and monthly during the first three months of the postoperative period (ending at 3 months postoperatively).). The study lists 4 primary outcomes in all. 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 NCT06735547, which also lists 12 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 16 Dec 2024.