Knee ArthropathyEarly Phase 1NCT03849274
SMART Dressing for Hypertrophic Scar Treatment Post-Total Knee/Hip Arthroplasty
A Early Phase 1 study testing Smart Scar Care Pad=Pressure Garment and Pressure Garment in people with Knee Arthropathy and Hip Arthropathy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Pressure therapy (PT) and silicone therapy are recommended as first-line non-invasive treatment for Hypertrophic Scar (HS), yet the effectiveness of the combination of these two treatments through an RCT trial has not been established yet. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Arthropathy, Hip Arthropathy, Hypertrophic Scar
- What is being tested?
- Smart Scar Care Pad=Pressure Garment and Pressure Garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Jan 2020to 31 Jul 2021
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (age over 18 years old) undergoing TKR and THR within 6 weeks;
- Adult who is able to provide written consent, is cooperative and compliant with the treatment and assessment regime;
- The Vancouver Scar Scale (VSS) will be used to screen candidates for the study.10 Isolated scars with a total score of 4 or higher and the score of each item equal to or greater than 1 will be included.
Who cannot join
- The HS area has an open wound or infection, or HS area is local flap or skin graft area;
- The HS area intends to be treated with steroid injections or other interventions (such as traditional Chinese medicine or laser therapy)
- The patients with co-morbidities that might affect their compliance to treatment such as dermatological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Combined Adequate Pressure and Silicone Intervention in Comparison With Conventional Pressure for Hypertrophic Scar Treatment
Pressure therapy (PT) and silicone therapy are recommended as first-line non-invasive treatment for Hypertrophic Scar (HS), yet the effectiveness of the combination of these two treatments through an RCT trial has not been established yet. This study aims to examine the effectiveness of the combination of adequate pressure therapy and silicone gel sheeting implemented by Smart Scar Care Pad (SSCP) + conventional Pressure Garment (PG) versus conventional Pressure Garment (PG) alone in the management of HS in adult with total hip replacement (THR) and total knee replacement (TKR). This study also aims to find out the prevalence of hypertrophic scar among patients with THR and TKR. This study is a randomised controlled trial with two parallel arms, with allocation ratio (Experimental: Control) of 1: 1 in order to establish the superiority of SSCP + PG over PG. Subjects with hypertrophic scar will be randomly assigned to either treatment or control group. The subjects in the treatment group will be provided with the SSCP and PG for treatment, whereas the subjects in the control group will be prescribed only the PG. The treatment will last for a total of 6 months. A variety of objective outcome measures will be used to analysis the treatment effect.
Read the detailed description
Hypertrophic scar (HS) is a challenging yet common complication of dermal injuries such as burns, surgeries, and trauma. It is characterized as a raised, rigid, hyper-vascular, and abnormally pigmented scar confined within the border of the initial injury. The induced aesthetic defect and impaired physical function could adversely affect quality of life.1 Pressure therapy (PT) and silicone therapy are recommended as first-line non-invasive treatments HS.
Recent reviews suggested PT was able to decrease scar height and erythema3,4. The inconclusive outcome results from fact that seldom research address the issue of adequate pressure dosage, which is essential for the treatment effect of PT. It is recommended that an interface pressure of 15-25 mmHg should be given and maintained through a 23 hrs/day wearing regime in order to achieve optimal treatment outcomes5. However, maintaining adequate pressure dosage through pressure garment alone is usually uncomfortable and sometimes impossible, especially over bodily concave area. Therefore, pressure inserts are used in conjunction with pressure garment to increase local pressure6. Despite the documented use of pressure inserts in various journals, pressure garment alone remains the mainstream treatment for hypertrophic scar.
Cochrane review conducted on silicone gel sheet (SGS) revealed SGS's ability in reducing scar thickness and improving scar color, but insufficient data on its effect on scar pliability5. SGS are commonly used to occlude and provide hydration to scar tissues.5, 6 They are mainly used for small scars or surgical scars. They are generally costly and thin in physical form, rendering them incapable of exerting sufficient pressure.
The joint effectiveness of these two treatment modalities in scar management is always drawing the interests from researchers. Various studies reported that enhanced effectiveness could be achieved through the combination of PT and SGS especially in terms of scar pliability, though all subjectively measured6-8. Therefore, there is an urging need to establish the effectiveness of the combination of these two treatments through an RCT.
In order to address the adequate pressure as well as the silicone gel sheeting effect at the same time, a newly invented insert material, the Smart Scar Care Pad (SSCP), is adopted in this study as treatment modality. The Smart Scar Care Pad is especially designed with a rubbery silicone stiffener layer and medical grade silicone gel lining layer underneath. The medical grade silicone gel lining layer underneath serves as the occlusion layer. The rubbery silicone stiffener layer is designed with numerous studs. By cutting the individual studs into gradient height, the Smart Scar Care Pad (SSCP), creates tailor made localized pressure under pressure garment. Studs are also aligned in honey cone style in order to maximize conformability over different bodily contours. In that case, the Smart Scar Care Pad (SSCP) not only increases local pressure but also provides occlusion to HS tissue.
- Conditions
- Knee Arthropathy, Hip Arthropathy, Hypertrophic Scar
- Being tested
- Smart Scar Care Pad=Pressure Garment, Pressure Garment
- Keywords
- Knee Arthropathy, Hip Arthopathy, Hypertrophic Scar, Smart Scar Care Pad, Pressure Garment
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Scar Care Pad=Pressure GarmentCombination product
Smart Scar Care Pad (SSCP) + conventional Pressure Garment in the management of HS in adult with total hip replacement (THR) and total knee replacement (TKR)
Pressure GarmentDevice
Conventional Pressure Garment (PG) alone in the management of HS in adult with total hip replacement (THR) and total knee replacement (TKR)
| Study group | Role | What they receive |
|---|---|---|
| Smart Scar Care Pad+Pressure Garment | Experimental | For experiment group, subject will be intervened by SSCP plus PG Receives: Combination Product: Smart Scar Care Pad=Pressure Garment; Device: Pressure Garment |
| Pressure Garment | Active comparator | For control group, subject will be intervened by conventional PG only Receives: Device: Pressure Garment |
| Non-eligible patients (with VSS less than 4) | No intervention | Non-eligible subjects with VSS less than 4 will be followed up for 6 months and assessment results will be recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline hypertrophic Scar Thickness at 1 months post-surgical to total knee/hip arthroplasty
Using an ultrasound machine, thickness of scar is aggregately measured to the average of 3 points: the center of the inner ring, 5 mm on both side of the centre point, which reflected the points of circumference of the selected scar sites.
Measured: 1 month post total knee/hip arthroplasty operation
Changes from baseline hypertrophic Scar Thickness at 3 months post-surgical to total knee/hip arthroplasty
Using an ultrasound machine, thickness of scar is aggregately measured to the average of 3 points: the center of the inner ring, 5 mm on both side of the centre point, which reflected the points of circumference of the selected scar sites.
Measured: 3 month post total knee/hip arthroplasty operation
Changes from baseline hypertrophic Scar Thickness at 6 months post-surgical to total knee/hip arthroplasty
Using an ultrasound machine, thickness of scar is aggregately measured to the average of 3 points: the center of the inner ring, 5 mm on both side of the centre point, which reflected the points of circumference of the selected scar sites.
Measured: 6 month post total knee/hip arthroplasty operation
Secondary outcomes (21)
Changes of scar vascularity and pigmentation at 1 month post-surgical to total knee/hip arthroplasty
Hypertrophic scar vascularity and pigmentation will be measured using the Dermlite Foto II Pro (3GEN Inc., San Juan Capistrano, CA, USA).
Measured: 1 month post total knee/hip arthroplasty operation
Changes of scar vascularity and pigmentation at 3 months post-surgical to total knee/hip arthroplasty
Hypertrophic scar vascularity and pigmentation will be measured using the Dermlite Foto II Pro (3GEN Inc., San Juan Capistrano, CA, USA).
Measured: 3 months post total knee/hip arthroplasty operation
Changes of scar vascularity and pigmentation at 6 month post-surgical to total knee/hip arthroplasty
Hypertrophic scar vascularity and pigmentation will be measured using the Dermlite Foto II Pro (3GEN Inc., San Juan Capistrano, CA, USA).
Measured: 6 month post total knee/hip arthroplasty operation
Changes of scar elasticity at 1 month post-surgical to total knee/hip arthroplasty
Hypertrophic scar elasticity will be measured using the DermaLab Combo (Cortex Technology, Hadsund, Denmark)
Measured: 1 month post total knee/hip arthroplasty operation
Changes of scar elasticity at 3 months post-surgical to total knee/hip arthroplasty
Hypertrophic scar elasticity will be measured using the DermaLab Combo (Cortex Technology, Hadsund, Denmark)
Measured: 3 months post total knee/hip arthroplasty operation
Changes of scar elasticity at 6 months post-surgical to total knee/hip arthroplasty
Hypertrophic scar elasticity will be measured using the DermaLab Combo (Cortex Technology, Hadsund, Denmark)
Measured: 6 months post total knee/hip arthroplasty operation
Changes of range of motion (ROM) of knee joint or hip joint at 1 month post-surical to total knee/hip arthroplasty
It describes the joint movement range. Physical therapist will manually bend and straighten patients' knee, passively moving legs .
Measured: 1 month post total knee/hip arthroplasty operation
Changes of range of motion (ROM) of knee joint or hip joint at 3 months post-surical to total knee/hip arthroplasty
It describes the joint movement range. Physical therapist will manually bend and straighten patients' knee, passively moving legs .
Measured: 3 months post total knee/hip arthroplasty operation
Changes of range of motion (ROM) of knee joint or hip joint at 6 months post-surical to total knee/hip arthroplasty
It describes the joint movement range. Physical therapist will manually bend and straighten patients' knee, passively moving legs .
Measured: 6 months post total knee/hip arthroplasty operation
Changes of circumference measurement of knee joint or hip joint at 1 month post-surgical to total knee/hip arthroplasty
It describes the circumference of joint in centimeter units.
Measured: 1 month post-surgical to total knee/hip arthroplasty
Changes of circumference measurement of knee joint or hip joint at 3 months post-surgical to total knee/hip arthroplasty
It describes the circumference of joint in centimeter units.
Measured: 3 months post-surgical to total knee/hip arthroplasty
Changes of circumference measurement of knee joint or hip joint at 6 months post-surgical to total knee/hip arthroplasty
It describes the circumference of joint in centimeter units.
Measured: 6 months post-surgical to total knee/hip arthroplasty
Changes of pain/itchiness sensation at 1 month post-surgical to total knee/hip arthroplasty
Numerical rating scale (NRS) will be used to measure itchiness and pain. Patient are asked to point to the number on the Numeric Rating Scale that best represents the intensity of their pain NOW. The scale have a scale ranges from 0 to 10, with higher the number considering the worse possible pain/itchiness sensation.
Measured: 1 month post-surgical to total knee/hip arthroplasty
Changes of pain/itchiness sensation at 3 months post-surgical to total knee/hip arthroplasty
Numerical rating scale (NRS) will be used to measure itchiness and pain. Patient are asked to point to the number on the Numeric Rating Scale that best represents the intensity of their pain NOW. The scale have a scale ranges from 0 to 10, with higher the number considering the worse possible pain/itchiness sensation.
Measured: 3 months post-surgical to total knee/hip arthroplasty
Changes of pain/itchiness sensation at 6 months post-surgical to total knee/hip arthroplasty
Numerical rating scale (NRS) will be used to measure itchiness and pain. Patient are asked to point to the number on the Numeric Rating Scale that best represents the intensity of their pain NOW. The scale have a scale ranges from 0 to 10, with higher the number considering the worse possible pain/itchiness sensation.
Measured: 6 months post-surgical to total knee/hip arthroplasty
Changes of The 36-Item Short Form Health Survey (SF-36) index at 1 month post-surgical to total knee/hip arthroplasty
The 36-Item Short Form Health Survey (SF-36) will be used to measure the health related Quality of Life. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.
Measured: 1 month post-surgical to total knee/hip arthroplasty
Changes of The 36-Item Short Form Health Survey (SF-36) index at 3 months post-surgical to total knee/hip arthroplasty
The 36-Item Short Form Health Survey (SF-36) will be used to measure the health related Quality of Life. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.
Measured: 3 months post-surgical to total knee/hip arthroplasty
Changes of The 36-Item Short Form Health Survey (SF-36) index at 6 months post-surgical to total knee/hip arthroplasty
The 36-Item Short Form Health Survey (SF-36) will be used to measure the health related Quality of Life. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.
Measured: 6 months post-surgical to total knee/hip arthroplasty
Changes of treatment satisfaction value at 1 month post-surgical to total knee/hip arthroplasty
Numerical rating scale (NRS) will be used to measure treatment satisfaction. Patient are asked to point to the number on the Numeric Rating Scale that best represents the intensity of their pain NOW. The scale have a scale ranges from 0 to 10, with higher the number considering the better treatment satisfaction.
Measured: 1 month post-surgical to total knee/hip arthroplasty
Changes of treatment satisfaction value at 3 months post-surgical to total knee/hip arthroplasty
Numerical rating scale (NRS) will be used to measure treatment satisfaction. Patient are asked to point to the number on the Numeric Rating Scale that best represents the intensity of their pain NOW. The scale have a scale ranges from 0 to 10, with higher the number considering the better treatment satisfaction.
Measured: 3 months post-surgical to total knee/hip arthroplasty
Changes of treatment satisfaction value at 6 months post-surgical to total knee/hip arthroplasty
Numerical rating scale (NRS) will be used to measure treatment satisfaction. Patient are asked to point to the number on the Numeric Rating Scale that best represents the intensity of their pain NOW. The scale have a scale ranges from 0 to 10, with higher the number considering the better treatment satisfaction.
Measured: 6 months post-surgical to total knee/hip arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start31 Jan 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Dr. Ho Ki Wai, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849274
- Sponsor's protocol ID
- CUHK_2018.487-T
- Status last verified
- Mar 2022
- First submitted
- 11 Feb 2019
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combined Adequate Pressure and Silicone Intervention in Comparison With Conventional Pressure for Hypertrophic Scar Treatment
- ClinicalTrials.gov ID
- NCT03849274
- Acronym / sponsor ID
- CUHK_2018.487-T
- Conditions
- Knee Arthropathy, Hip Arthropathy, Hypertrophic Scar
- Keywords
- Knee Arthropathy, Hip Arthopathy, Hypertrophic Scar, Smart Scar Care Pad, Pressure Garment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 21 Feb 2019 (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.
Pressure therapy (PT) and silicone therapy are recommended as first-line non-invasive treatment for Hypertrophic Scar (HS), yet the effectiveness of the combination of these two treatments through an RCT trial has not been established yet. This study aims to examine the effectiveness of the combination of adequate pressure therapy and silicone gel sheeting implemented by Smart Scar Care Pad (SSCP) + conventional Pressure Garment (PG) versus conventional Pressure Garment (PG) alone in the management of HS in adult with total hip replacement (THR) and total knee replacement (TKR). This study also aims to find out the prevalence of hypertrophic scar among patients with THR and TKR. This study is a randomised controlled trial with two parallel arms, with allocation ratio (Experimental: Control) of 1: 1 in order to establish the superiority of SSCP + PG over PG. Subjects with hypertrophic scar will be randomly assigned to either treatment or control group. The subjects in the treatment group will be provided with the SSCP and PG for treatment, whereas the subjects in the control group will be prescribed only the PG. The treatment will last for a total of 6 months. A variety of objective outcome measures will be used to analysis the treatment effect.
Detailed description
Hypertrophic scar (HS) is a challenging yet common complication of dermal injuries such as burns, surgeries, and trauma. It is characterized as a raised, rigid, hyper-vascular, and abnormally pigmented scar confined within the border of the initial injury. The induced aesthetic defect and impaired physical function could adversely affect quality of life.1 Pressure therapy (PT) and silicone therapy are recommended as first-line non-invasive treatments HS.
Recent reviews suggested PT was able to decrease scar height and erythema3,4. The inconclusive outcome results from fact that seldom research address the issue of adequate pressure dosage, which is essential for the treatment effect of PT. It is recommended that an interface pressure of 15-25 mmHg should be given and maintained through a 23 hrs/day wearing regime in order to achieve optimal treatment outcomes5. However, maintaining adequate pressure dosage through pressure garment alone is usually uncomfortable and sometimes impossible, especially over bodily concave area. Therefore, pressure inserts are used in conjunction with pressure garment to increase local pressure6. Despite the documented use of pressure inserts in various journals, pressure garment alone remains the mainstream treatment for hypertrophic scar.
Cochrane review conducted on silicone gel sheet (SGS) revealed SGS's ability in reducing scar thickness and improving scar color, but insufficient data on its effect on scar pliability5. SGS are commonly used to occlude and provide hydration to scar tissues.5, 6 They are mainly used for small scars or surgical scars. They are generally costly and thin in physical form, rendering them incapable of exerting sufficient pressure.
The joint effectiveness of these two treatment modalities in scar management is always drawing the interests from researchers. Various studies reported that enhanced effectiveness could be achieved through the combination of PT and SGS especially in terms of scar pliability, though all subjectively measured6-8. Therefore, there is an urging need to establish the effectiveness of the combination of these two treatments through an RCT.
In order to address the adequate pressure as well as the silicone gel sheeting effect at the same time, a newly invented insert material, the Smart Scar Care Pad (SSCP), is adopted in this study as treatment modality. The Smart Scar Care Pad is especially designed with a rubbery silicone stiffener layer and medical grade silicone gel lining layer underneath. The medical grade silicone gel lining layer underneath serves as the occlusion layer. The rubbery silicone stiffener layer is designed with numerous studs. By cutting the individual studs into gradient height, the Smart Scar Care Pad (SSCP), creates tailor made localized pressure under pressure garment. Studs are also aligned in honey cone style in order to maximize conformability over different bodily contours. In that case, the Smart Scar Care Pad (SSCP) not only increases local pressure but also provides occlusion to HS tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smart Scar Care Pad+Pressure Garment | Experimental | Combination Product: Smart Scar Care Pad=Pressure Garment, Device: Pressure GarmentFor experiment group, subject will be intervened by SSCP plus PG |
| Pressure Garment | Active comparator | Device: Pressure GarmentFor control group, subject will be intervened by conventional PG only |
| Non-eligible patients (with VSS less than 4) | No intervention | –Non-eligible subjects with VSS less than 4 will be followed up for 6 months and assessment results will be recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (age over 18 years old) undergoing TKR and THR within 6 weeks;
- Adult who is able to provide written consent, is cooperative and compliant with the treatment and assessment regime;
- The Vancouver Scar Scale (VSS) will be used to screen candidates for the study.10 Isolated scars with a total score of 4 or higher and the score of each item equal to or greater than 1 will be included.
Key exclusion criteria (3 listed)
- The HS area has an open wound or infection, or HS area is local flap or skin graft area;
- The HS area intends to be treated with steroid injections or other interventions (such as traditional Chinese medicine or laser therapy)
- The patients with co-morbidities that might affect their compliance to treatment such as dermatological disorders.
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 |
|---|---|---|
| Smart Scar Care Pad=Pressure GarmentSmart Scar Care Pad (SSCP) + conventional Pressure Garment in the management of HS in adult with total hip replacement (THR) and total knee replacement (TKR) | Combination product | Smart Scar Care Pad+Pressure Garment |
| Pressure GarmentConventional Pressure Garment (PG) alone in the management of HS in adult with total hip replacement (THR) and total knee replacement (TKR) | Device | Pressure Garment, Smart Scar Care Pad+Pressure Garment |
Primary outcome
Changes from baseline hypertrophic Scar Thickness at 1 months post-surgical to total knee/hip arthroplasty
Time frame: 1 month post total knee/hip arthroplasty operation
Using an ultrasound machine, thickness of scar is aggregately measured to the average of 3 points: the center of the inner ring, 5 mm on both side of the centre point, which reflected the points of circumference of the selected scar sites.
Changes from baseline hypertrophic Scar Thickness at 3 months post-surgical to total knee/hip arthroplasty
Time frame: 3 month post total knee/hip arthroplasty operation
Using an ultrasound machine, thickness of scar is aggregately measured to the average of 3 points: the center of the inner ring, 5 mm on both side of the centre point, which reflected the points of circumference of the selected scar sites.
Changes from baseline hypertrophic Scar Thickness at 6 months post-surgical to total knee/hip arthroplasty
Time frame: 6 month post total knee/hip arthroplasty operation
Using an ultrasound machine, thickness of scar is aggregately measured to the average of 3 points: the center of the inner ring, 5 mm on both side of the centre point, which reflected the points of circumference of the selected scar sites.
21 secondary outcomes
Changes of scar vascularity and pigmentation at 1 month post-surgical to total knee/hip arthroplasty
Time frame: 1 month post total knee/hip arthroplasty operation
Changes of scar vascularity and pigmentation at 3 months post-surgical to total knee/hip arthroplasty
Time frame: 3 months post total knee/hip arthroplasty operation
Changes of scar vascularity and pigmentation at 6 month post-surgical to total knee/hip arthroplasty
Time frame: 6 month post total knee/hip arthroplasty operation
Changes of scar elasticity at 1 month post-surgical to total knee/hip arthroplasty
Time frame: 1 month post total knee/hip arthroplasty operation
Changes of scar elasticity at 3 months post-surgical to total knee/hip arthroplasty
Time frame: 3 months post total knee/hip arthroplasty operation
Changes of scar elasticity at 6 months post-surgical to total knee/hip arthroplasty
Time frame: 6 months post total knee/hip arthroplasty operation
Changes of range of motion (ROM) of knee joint or hip joint at 1 month post-surical to total knee/hip arthroplasty
Time frame: 1 month post total knee/hip arthroplasty operation
Changes of range of motion (ROM) of knee joint or hip joint at 3 months post-surical to total knee/hip arthroplasty
Time frame: 3 months post total knee/hip arthroplasty operation
Changes of range of motion (ROM) of knee joint or hip joint at 6 months post-surical to total knee/hip arthroplasty
Time frame: 6 months post total knee/hip arthroplasty operation
Changes of circumference measurement of knee joint or hip joint at 1 month post-surgical to total knee/hip arthroplasty
Time frame: 1 month post-surgical to total knee/hip arthroplasty
Changes of circumference measurement of knee joint or hip joint at 3 months post-surgical to total knee/hip arthroplasty
Time frame: 3 months post-surgical to total knee/hip arthroplasty
Changes of circumference measurement of knee joint or hip joint at 6 months post-surgical to total knee/hip arthroplasty
Time frame: 6 months post-surgical to total knee/hip arthroplasty
Changes of pain/itchiness sensation at 1 month post-surgical to total knee/hip arthroplasty
Time frame: 1 month post-surgical to total knee/hip arthroplasty
Changes of pain/itchiness sensation at 3 months post-surgical to total knee/hip arthroplasty
Time frame: 3 months post-surgical to total knee/hip arthroplasty
Changes of pain/itchiness sensation at 6 months post-surgical to total knee/hip arthroplasty
Time frame: 6 months post-surgical to total knee/hip arthroplasty
Changes of The 36-Item Short Form Health Survey (SF-36) index at 1 month post-surgical to total knee/hip arthroplasty
Time frame: 1 month post-surgical to total knee/hip arthroplasty
Changes of The 36-Item Short Form Health Survey (SF-36) index at 3 months post-surgical to total knee/hip arthroplasty
Time frame: 3 months post-surgical to total knee/hip arthroplasty
Changes of The 36-Item Short Form Health Survey (SF-36) index at 6 months post-surgical to total knee/hip arthroplasty
Time frame: 6 months post-surgical to total knee/hip arthroplasty
Changes of treatment satisfaction value at 1 month post-surgical to total knee/hip arthroplasty
Time frame: 1 month post-surgical to total knee/hip arthroplasty
Changes of treatment satisfaction value at 3 months post-surgical to total knee/hip arthroplasty
Time frame: 3 months post-surgical to total knee/hip arthroplasty
Changes of treatment satisfaction value at 6 months post-surgical to total knee/hip arthroplasty
Time frame: 6 months post-surgical to total knee/hip arthroplasty
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 15 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Knee Arthropathy
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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 Early Phase 1 study testing Smart Scar Care Pad=Pressure Garment and Pressure Garment in people with Knee Arthropathy and Hip Arthropathy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 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 15 Mar 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 Hong Kong. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes from baseline hypertrophic Scar Thickness at 1 months post-surgical to total knee/hip arthroplasty (time frame: 1 month post total knee/hip arthroplasty operation). The study lists 3 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 15 Mar 2022.