Osteoarthritis of KneesNCT03452423
The Effectiveness of Arthroscopic Cartilage Regeneration Facilitating Procedure for Patients With Knee Osteoarthritis
A study testing ACRFP in people with Osteoarthritis of Knees, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
The aim of this study is to discuss the effect of gait pattern in patients receiving arthroscopic cartilage regeneration facilitating procedure (ACRFP) for treatment of osteoarthritis of knees. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Osteoarthritis of Knees
- What is being tested?
- ACRFP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 May 2017to 31 Dec 2018
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages 20 and 85 who will receive ACRFP for treatment of osteoarthritis in the knee joints
Who cannot join
- Patients with walking disability
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Buddhist Taipei Tzu Chi General Hospital
New Taipei City
Shuo-Suei Hung, PhD, +886266289009, hung_ortho@yahoo.com.tw
About this study
Official title: The Effect on Gait Pattern in Patients Receiving Arthroscopic Cartilage Regeneration Facilitating Procedure (ACRFP) for Treatment of Osteoarthritis
The aim of this study is to discuss the effect of gait pattern in patients receiving arthroscopic cartilage regeneration facilitating procedure (ACRFP) for treatment of osteoarthritis of knees.
Read the detailed description
Pain during gait is the most common and problematic symptom in individuals with osteoarthritis (OA) of knee joints. Limited range of motion, reduced walking speed, and a shortened stride length are also occasionally observed. These changes may be secondary or compensatory phenomena adopted by individuals to lessen the load on the OA-affected knees.
It is generally agreed that medial plica can produce symptoms in the knee joint, and can be successfully treated by arthroscopic resection when it becomes inflamed, thickened, and fibrotic. In 2006, Lyu and Hsu reported that medial plica had strong correlation with medial compartment osteoarthritis of knees. In their further studies disclosing the kinematic relationship of the medial plica with the medial femoral condyle found that medial plica might cause some degree of abrasion on the surface of medial femoral condyle during knee motion. The repeated injuries elicited by this abrasion phenomenon might trigger some inflammatory process to gradually damage the cartilage of knee.
Based on these findings, Lyu developed a concept of arthroscopic cartilage regeneration facilitating procedure (ACRFP) by arthroscopic resection of the medial plica, in addition to both medial and lateral capsular release, for the treatment of osteoarthritis of the knee joint. The clinical outcome of this procedure by eradication of the abrasion phenomenon caused by the tight, fibrotic, and hypertrophied medial plica, with decompression of the patellofemoral joint, the pain in most patients could be reduced, and the degenerative process in the medial compartment of some patients might be decelerated or arrested.
During the ACRFP, additional procedures such as synovectomy, abrasiochondroplasty, or partial menisectomy may also be carried out when necessary. It has been found that the elimination of the existing detrimental factors may provide a preferable environment for regeneration of the damaged cartilage.
Although the results of ACRFP for treatment of osteoarthritis of knee has been supported by several researches as being an effective method, it still lacks investigations on the gait pattern after such procedure. Therefore, the aim of this study is to discuss the effectiveness of the ACRFP for the patients with osteoarthritis of knee joints, specifically focused on their gait pattern.
- Conditions
- Osteoarthritis of Knees
- Being tested
- ACRFP
- Keywords
- Osteoarthritis of knees, Arthroscopic cartilage regeneration facilitating procedure (ACRFP), Foot pressure, Gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACRFPProcedure or surgery
Arthroscopic cartilage regeneration facilitating procedure (ACRFP) is a set of surgical procedures that combines resection of medial plica, medial and lateral capsular release, synovectomy of focal synovitis, and chondroplasty of loosened cartilage flaps as a rationale for the deliberate arthroscopic management of osteoarthritic knee.
| Study group | Role | What they receive |
|---|---|---|
| ACRFP | Experimental | Patient suffering from osteoarthritis of knee joints, and planning to receive ACRFP, are enrolled into this study. Gait pattern is obtained preoperatively, 3 months, and 6 months postoperatively. Receives: Procedure: ACRFP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial foot pressure as a percentage of body weight
ach footprint during gait are divided into 6 areas, which are medial forefoot, medial midfoot, medial hindfoot, lateral forefoot, lateral midfoot, and lateral hindfoot. The average partial foot pressure in each area was then calculated in terms of the percentage of body weight.
Measured: Before intervention, at 3 months and 6 months after intervention
Secondary outcomes (8)
The Knee injury and Osteoarthritis Outcome Score (KOOS)
A questionnaire to assess the patient's subjective symptoms about their knee joints and associated problems caused by the disorders
Measured: Before surgery, at 3 months, and 6 months after intervention
Partial foot area as a percentage of body mass index (BMI)
Each footprint during gait are divided into 6 areas, which are medial forefoot, medial midfoot, medial hindfoot, lateral forefoot, lateral midfoot, and lateral hindfoot. The average partial foot pressure in each area was then calculated in terms of the body mass index (BMI).
Measured: Before surgery, at 3 months, and 6 months after intervention
Gait Cadence
The number of steps per minute
Measured: Before surgery, at 3 months, and 6 months after intervention
Walking speed
The velocity of each single step
Measured: Before surgery, at 3 months, and 6 months after intervention
Single leg stance time
The length of time of each foot at the stance phase
Measured: Before surgery, at 3 months, and 6 months after intervention
Step length
The distance between the first point of contact of the foot with the ground and that of the contralateral foot
Measured: Before surgery, at 3 months, and 6 months after intervention
Step width
The distance between the center of the heel contact and the following one, calculated perpendicularly to the direction of the horizontal axis drawn between the feet
Measured: Before surgery, at 3 months, and 6 months after intervention
Axis angle
the angle formed by the medial tangent of the foot and the line from the second/third toe to the center of the heel
Measured: Before surgery, at 3 months, and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start30 May 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of KneesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuo-Suei Hung, PhD, Principal investigator, Buddhist Taipei Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452423
- Sponsor's protocol ID
- 05-XD41-074
- Status last verified
- Nov 2017
- First submitted
- 1 Feb 2018
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Gait Pattern in Patients Receiving Arthroscopic Cartilage Regeneration Facilitating Procedure (ACRFP) for Treatment of Osteoarthritis
- ClinicalTrials.gov ID
- NCT03452423
- Acronym / sponsor ID
- 05-XD41-074
- Conditions
- Osteoarthritis of Knees
- Keywords
- Osteoarthritis of knees, Arthroscopic cartilage regeneration facilitating procedure (ACRFP), Foot pressure, Gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 30 May 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 2 Mar 2018 (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.
The aim of this study is to discuss the effect of gait pattern in patients receiving arthroscopic cartilage regeneration facilitating procedure (ACRFP) for treatment of osteoarthritis of knees.
Detailed description
Pain during gait is the most common and problematic symptom in individuals with osteoarthritis (OA) of knee joints. Limited range of motion, reduced walking speed, and a shortened stride length are also occasionally observed. These changes may be secondary or compensatory phenomena adopted by individuals to lessen the load on the OA-affected knees.
It is generally agreed that medial plica can produce symptoms in the knee joint, and can be successfully treated by arthroscopic resection when it becomes inflamed, thickened, and fibrotic. In 2006, Lyu and Hsu reported that medial plica had strong correlation with medial compartment osteoarthritis of knees. In their further studies disclosing the kinematic relationship of the medial plica with the medial femoral condyle found that medial plica might cause some degree of abrasion on the surface of medial femoral condyle during knee motion. The repeated injuries elicited by this abrasion phenomenon might trigger some inflammatory process to gradually damage the cartilage of knee.
Based on these findings, Lyu developed a concept of arthroscopic cartilage regeneration facilitating procedure (ACRFP) by arthroscopic resection of the medial plica, in addition to both medial and lateral capsular release, for the treatment of osteoarthritis of the knee joint. The clinical outcome of this procedure by eradication of the abrasion phenomenon caused by the tight, fibrotic, and hypertrophied medial plica, with decompression of the patellofemoral joint, the pain in most patients could be reduced, and the degenerative process in the medial compartment of some patients might be decelerated or arrested.
During the ACRFP, additional procedures such as synovectomy, abrasiochondroplasty, or partial menisectomy may also be carried out when necessary. It has been found that the elimination of the existing detrimental factors may provide a preferable environment for regeneration of the damaged cartilage.
Although the results of ACRFP for treatment of osteoarthritis of knee has been supported by several researches as being an effective method, it still lacks investigations on the gait pattern after such procedure. Therefore, the aim of this study is to discuss the effectiveness of the ACRFP for the patients with osteoarthritis of knee joints, specifically focused on their gait pattern.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACRFP | Experimental | Procedure: ACRFPPatient suffering from osteoarthritis of knee joints, and planning to receive ACRFP, are enrolled into this study. Gait pattern is obtained preoperatively, 3 months, and 6 months postoperatively. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between the ages 20 and 85 who will receive ACRFP for treatment of osteoarthritis in the knee joints
Key exclusion criteria (1 listed)
- Patients with walking disability
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 |
|---|---|---|
| ACRFPArthroscopic cartilage regeneration facilitating procedure (ACRFP) is a set of surgical procedures that combines resection of medial plica, medial and lateral capsular release, synovectomy of focal synovitis, and chondroplasty of loosened cartilage flaps as a rationale for the deliberate arthroscopic management of osteoarthritic knee. | Procedure or surgery | ACRFP |
Primary outcome
Partial foot pressure as a percentage of body weight
Time frame: Before intervention, at 3 months and 6 months after intervention
ach footprint during gait are divided into 6 areas, which are medial forefoot, medial midfoot, medial hindfoot, lateral forefoot, lateral midfoot, and lateral hindfoot. The average partial foot pressure in each area was then calculated in terms of the percentage of body weight.
8 secondary outcomes
The Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Before surgery, at 3 months, and 6 months after intervention
Partial foot area as a percentage of body mass index (BMI)
Time frame: Before surgery, at 3 months, and 6 months after intervention
Gait Cadence
Time frame: Before surgery, at 3 months, and 6 months after intervention
Walking speed
Time frame: Before surgery, at 3 months, and 6 months after intervention
Single leg stance time
Time frame: Before surgery, at 3 months, and 6 months after intervention
Step length
Time frame: Before surgery, at 3 months, and 6 months after intervention
Step width
Time frame: Before surgery, at 3 months, and 6 months after intervention
Axis angle
Time frame: Before surgery, at 3 months, and 6 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
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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.
Shuo-Suei Hung, PhD principal investigator
Buddhist Taipei Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACRFP in people with Osteoarthritis of Knees, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Mar 2018. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuan-Hsin Yen, BS (+886933301155, Yanlisa0728@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial foot pressure as a percentage of body weight (time frame: Before intervention, at 3 months and 6 months after intervention). 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 2 Mar 2018.