Knee OsteoarthritisIPAKANCT03763448
Infrapatellar Fat Pad Preservation Versus Resection on Clinical Outcomes After Total Knee Arthroplasty(IPAKA)
A study testing Infrapatellar Fat Pad preservation and Infrapatellar Fat Pad resection in people with Knee Osteoarthritis and Arthropathy of Knee, run by Zhujiang Hospital at 1 site in China.
Trial summary
This study aims to compare the postoperative clinical outcomes of Infrapatellar Fat Pad (IPFP) preservation versus resection after total knee arthroplasty (TKA) in patients with knee osteoarthritis. Participants will be identified as normal IPFP or abnormal IPFP based on MRI findings before randomization. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Arthropathy of Knee
- What is being tested?
- Infrapatellar Fat Pad preservation and Infrapatellar Fat Pad resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 377 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2018to 13 May 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with knee osteoarthritis by X-ray plain film (Kellgren-Lawrence score of ≥ 2)
- The need for TKA was confirmed after evaluation by the orthopedic surgeon
- One week before surgery, knee pain 100mm pain visual analogue scale score was greater than 20mm
- Understanding of the study requirements and willing to participate in this study
Who cannot join
- Rheumatoid arthritis,psoriatic arthritis,lupus,malignant tumor
- Requiring contralateral TKA within one year
- The visual analogue score of 100mm of knee pain before operation was less than 20mm
- Having a possible or planned pregnancy
- With poor compliance
- Suffering from somatic disease, psychiatric or cognitive disorders, neurological disorders that will compromise the safety, compliance, consent, participation, follow-up and the interpretation of the results
- Severe knee valgus
- Contraindications with TKA or MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Infrapatellar Fat Pad Preservation Versus Resection on Clinical Outcomes After Total Knee Arthroplasty in Patients With Knee Osteoarthritis - A Multicenter Randomized Controlled Clinical Trial
This study aims to compare the postoperative clinical outcomes of Infrapatellar Fat Pad (IPFP) preservation versus resection after total knee arthroplasty (TKA) in patients with knee osteoarthritis. Participants will be identified as normal IPFP or abnormal IPFP based on MRI findings before randomization. The primary outcome is the change from baseline to 12 months in the mean score on five Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales (KOOS5), covering pain, symptoms, activities of daily life, sport \& recreation, knee-related quality of life, with scores ranging from 0 (worst) to 100 (best). The secondary endpoints will be included: KOOS subscales, Knee Society Score (KSS), 100 mm Visual Analogue Scale (VAS) Pain, timed up-and-go test, depression, patellar tendon shortening, 100 mm VAS self-reported efficacy of reduced pain and increased quality of life. Adverse events will be recorded. Primary and secondary outcomes will be evaluated or reported blindly at baseline and at postoperative 3 months, 6 months, and 1 year. Intention-to-treat analyses will be used.
Read the detailed description
Knee Osteoarthritis (KOA) is a common chronic disease, which often leads to joint pain and limited function in the elderly, and thus affects participants' quality of life. Total knee arthroplasty (TKA) has been developed as a mature surgical procedure to relieve end-stage osteoarthritic joint pain and improve limb function. Although more than 80% of the patients reported in the literature are satisfied with the postoperative efficacy of TKA, there are still a large number of patients whose daily life is affected by persistent knee pain and limited function after the operation of the affected limb.
The IPFP is a fat mass located behind the patellar ligament, between the lower part of the patella and the tibial tubercle. The function of IPFP is controversial at present. It is reported that IPFP can provide blood supply for anterior cruciate ligament, patella and patellar ligament through the arterial network of the knee joint. In addition, it can fill the joint gap to lubricate the surface of the joint, reduce friction and absorb impulse so as to play a physiological protective role. On the contrary, studies have pointed out that abnormal IPFP could produce various pro-inflammatory cytokines such as interleukin (IL)-1β, tumour necrosis factor (TNF)-α, IL-6 and IL-8, as well as adipokines such as leptin and resistin, and thus might play a detrimental role in knee OA. Traditionally, the IPFP has been removed in order to improve surgical exposure and to prevent interposition during baseplate implantation. Despite the significant evolution of TKA technology which no longer requires the resection of IPFP for better surgical access, IPFP is still partially or totally resected in around 88% of TKAs.
The investigators' previous population-based cohort study revealed that IPFP maximal area and volume were associated with reduced knee pain, decreased loss of cartilage volume and reduced risks of cartilage defect progression, indicating a beneficial effect of IPFP size. On the other hand, the investigators' further investigation demonstrated that IPFP signal intensity alteration was negatively associated with maximum area of IPFP, and moreover, associated with increased knee cartilage defects, subchondral bone marrow lesion (BML) and knee pain, suggesting IPFP with abnormal quality may play a detrimental role in knee OA. Based on these findings, the investigators proposed that IPFP with normal quality should be preserved or not damaged during TKA, while IPFP with abnormal quality should be resected. This multicentre randomised controlled trial is designed to test the investigators' hypotheses: in patients with normal IPFP quality, preservation of IPFP during TKA procedure will reduce postoperative knee symptoms and improve joint function, comparing with IPFP resection during TKA procedures; in patients with abnormal IPFP quality, resection of IPFP during TKA procedure will reduce postoperative knee symptoms and improve joint function, comparing with IPFP preservation during TKA procedures. The results would provide evidence-based recommendations on clinical practice to improve OA patients' postoperative outcomes.
Three hundred and sixty eligible participants will be recruited and identified as having normal IPFP quality (signal intensity alteration score ≤ 1) or abnormal IPFP quality (signal intensity alteration score ≥ 2). Participants in each site will be randomly allocated to IPFP resection group or preservation group using computer-generated block randomisation.
- Conditions
- Knee Osteoarthritis, Arthropathy of Knee
- Being tested
- Infrapatellar Fat Pad preservation, Infrapatellar Fat Pad resection
- Keywords
- Infrapatellar Fat Pad, Knee Osteoarthritis, Total Knee Arthroplasty, Randomized Clinical Trial
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrapatellar Fat Pad preservationProcedure or surgery
Also called Infrapatellar fat pad retention
In the IPFP preservation group, IPFP (more than 80%) will be preserved by retracting out of the operative field.
Infrapatellar Fat Pad resectionProcedure or surgery
In the IPFP resection group, more than 80% IPFP will be resected during the total knee arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Infrapatellar Fat Pad Preservation | Experimental | The IPFP retention of more than 80% in actual operation shall be regarded as IPFP retention. Receives: Procedure: Infrapatellar Fat Pad preservation |
| Infrapatellar Fat Pad Resection | Active comparator | In the clinical practice, more than 80% of IPFP volume is commonly resected by surgeons during total knee arthroplasty. The investigators hereby define resection of more than 80% IPFP volume as IPFP excision. Receives: Procedure: Infrapatellar Fat Pad resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean score on five Knee Injury and Osteoarthritis Outcome Score(KOOS) subscales
The primary outcome was the change from baseline to 12 months in the mean score on five Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales, covering pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life (KOOS5), with scores ranging from 0 (worst) to 100 (best). The KOOS, a valid, reliable and responsive self-reported questionnaire applied to evaluate the short and long-term patient-relevant outcomes following TKA, consists of five subscales with a total of 42 items: pain (9 items), symptoms (7 items), function in ADL (17 items), sport and recreation function (5 items) and knee-related quality of life (4 items).
Measured: From pre-operation to 12 months after operation
Secondary outcomes (6)
Five individual subscales of Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS subscales including pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0-100 scale, with 0 representing worst health and 100 representing best health.
Measured: From pre-operation to 12 months after operation
Knee Society Score(KSS)
KSS is a rating system that consists of two scores: joint score and functional score. Both scores range from 0 (worst health or functioning) to 100 (best health or functioning).
Measured: From pre-operation to 12 months after operation
Self-reported efficacy of reduced pain and increased quality of life
Using a 100mm VAS with terminal descriptors of "very unsure" and "very sure"
Measured: From pre-operation to 12 months after operation
Insall - Salvati Ratio (ISR)
It is used to assess changes in the length of the patellar tendon at baseline and month 12. Lateral radiographs with the knee in about 30 degree of flexion will be taken by well experienced X-ray technicians using standardized radiographic techniques. The numerator of the ISR-the length of the patellar tendon-was determined by measuring the distance from inferior aspect of the patella to the superior aspect of the tibial tubercle. The longest dimension of the patella on the lateral radiograph will be obtained as denominator of the ISR.
Measured: From pre-operation to 12 months after operation
Timed Up and Go test
It is a simple test used to assess a person's mobility. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: From pre-operation to 12 months after operation
Visual Analogue Scale (VAS) Pain
Pain intensity measured on a 100 mm VAS with terminal descriptors of "no pain" and "worst pain possible" in the following situations: at rest, after 30-min of walking, and on most days of the last month.
Measured: From pre-operation to 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start17 Dec 2018
- Primary completion13 May 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Jinan University, Anhui Provincial Hospital, Tianjin Hospital, Youjiang Medical College for Nationalities, Xiangya Hospital of Central South University
- Responsible party
- Principal investigator, Ding Changhai, Zhujiang Hospital
- Investigators
- Changhai Ding, MD, Principal investigator, Clinical Research Center of Zhujiang Hospital,Southern Medical UniversityJianhao Lin, MD, Principal investigator, Peking University People's HospitalXisheng Weng, MD, Principal investigator, Peking Union Medical College HospitalGuanghua Lei, MD, Principal investigator, Xiangya Hospital of Central South UniversityZongsheng Yin, MD, Principal investigator, The First Affiliated Hospital of Anhui Medical UniversityZhengang Zha, MD, Principal investigator, First Affiliated Hospital of Jinan UniversityJing Tian, MD, Principal investigator, Zhujiang HospitalXifu Shang, MD, Principal investigator, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763448
- Sponsor's protocol ID
- 2017-GJGBK-001
- Acronym
- IPAKA
- Status last verified
- Nov 2025
- First submitted
- 19 Oct 2018
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Han W, Cao P, Cen H, Li B, Chen M, Li Y, Yang C, Lu M, Zhang H, Ke Y, Zhu Z, Liu X, Gao P, Zhou X, Liu Y, Dou Z, Liu Y, Zhang M, Lin J, Zha Z, Yin Z, Tian J, Lin L, Shang X, Hunter DJ, Liu J, Lei G, Ding C. Infrapatellar Fat Pad Preservation versus Resection in Total Knee Arthroplasty. NEJM Evid. 2026 Apr;5(4):EVIDoa2500135. doi: 10.1056/EVIDoa2500135. Epub 2026 Mar 24.
PubMed 41874257Zhu Z, Han W, Lu M, Lin J, Yin Z, Shang X, Weng X, Zha Z, Tian J, Lei G, Hunter DJ, Ding C. Effects of infrapatellar fat pad preservation versus resection on clinical outcomes after total knee arthroplasty in patients with knee osteoarthritis (IPAKA): study protocol for a multicentre, randomised, controlled clinical trial. BMJ Open. 2020 Oct 23;10(10):e043088. doi: 10.1136/bmjopen-2020-043088.
PubMed 33099502
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Infrapatellar Fat Pad Preservation Versus Resection on Clinical Outcomes After Total Knee Arthroplasty in Patients With Knee Osteoarthritis - A Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03763448
- Acronym / sponsor ID
- IPAKA / 2017-GJGBK-001
- Conditions
- Knee Osteoarthritis, Arthropathy of Knee
- Keywords
- Infrapatellar Fat Pad, Knee Osteoarthritis, Total Knee Arthroplasty, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Jinan University, Anhui Provincial Hospital, Tianjin Hospital, Youjiang Medical College for Nationalities, Xiangya Hospital of Central South University
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 4 Dec 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.
This study aims to compare the postoperative clinical outcomes of Infrapatellar Fat Pad (IPFP) preservation versus resection after total knee arthroplasty (TKA) in patients with knee osteoarthritis. Participants will be identified as normal IPFP or abnormal IPFP based on MRI findings before randomization. The primary outcome is the change from baseline to 12 months in the mean score on five Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales (KOOS5), covering pain, symptoms, activities of daily life, sport \& recreation, knee-related quality of life, with scores ranging from 0 (worst) to 100 (best). The secondary endpoints will be included: KOOS subscales, Knee Society Score (KSS), 100 mm Visual Analogue Scale (VAS) Pain, timed up-and-go test, depression, patellar tendon shortening, 100 mm VAS self-reported efficacy of reduced pain and increased quality of life. Adverse events will be recorded. Primary and secondary outcomes will be evaluated or reported blindly at baseline and at postoperative 3 months, 6 months, and 1 year. Intention-to-treat analyses will be used.
Detailed description
Knee Osteoarthritis (KOA) is a common chronic disease, which often leads to joint pain and limited function in the elderly, and thus affects participants' quality of life. Total knee arthroplasty (TKA) has been developed as a mature surgical procedure to relieve end-stage osteoarthritic joint pain and improve limb function. Although more than 80% of the patients reported in the literature are satisfied with the postoperative efficacy of TKA, there are still a large number of patients whose daily life is affected by persistent knee pain and limited function after the operation of the affected limb.
The IPFP is a fat mass located behind the patellar ligament, between the lower part of the patella and the tibial tubercle. The function of IPFP is controversial at present. It is reported that IPFP can provide blood supply for anterior cruciate ligament, patella and patellar ligament through the arterial network of the knee joint. In addition, it can fill the joint gap to lubricate the surface of the joint, reduce friction and absorb impulse so as to play a physiological protective role. On the contrary, studies have pointed out that abnormal IPFP could produce various pro-inflammatory cytokines such as interleukin (IL)-1β, tumour necrosis factor (TNF)-α, IL-6 and IL-8, as well as adipokines such as leptin and resistin, and thus might play a detrimental role in knee OA. Traditionally, the IPFP has been removed in order to improve surgical exposure and to prevent interposition during baseplate implantation. Despite the significant evolution of TKA technology which no longer requires the resection of IPFP for better surgical access, IPFP is still partially or totally resected in around 88% of TKAs.
The investigators' previous population-based cohort study revealed that IPFP maximal area and volume were associated with reduced knee pain, decreased loss of cartilage volume and reduced risks of cartilage defect progression, indicating a beneficial effect of IPFP size. On the other hand, the investigators' further investigation demonstrated that IPFP signal intensity alteration was negatively associated with maximum area of IPFP, and moreover, associated with increased knee cartilage defects, subchondral bone marrow lesion (BML) and knee pain, suggesting IPFP with abnormal quality may play a detrimental role in knee OA. Based on these findings, the investigators proposed that IPFP with normal quality should be preserved or not damaged during TKA, while IPFP with abnormal quality should be resected. This multicentre randomised controlled trial is designed to test the investigators' hypotheses: in patients with normal IPFP quality, preservation of IPFP during TKA procedure will reduce postoperative knee symptoms and improve joint function, comparing with IPFP resection during TKA procedures; in patients with abnormal IPFP quality, resection of IPFP during TKA procedure will reduce postoperative knee symptoms and improve joint function, comparing with IPFP preservation during TKA procedures. The results would provide evidence-based recommendations on clinical practice to improve OA patients' postoperative outcomes.
Three hundred and sixty eligible participants will be recruited and identified as having normal IPFP quality (signal intensity alteration score ≤ 1) or abnormal IPFP quality (signal intensity alteration score ≥ 2). Participants in each site will be randomly allocated to IPFP resection group or preservation group using computer-generated block randomisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infrapatellar Fat Pad Preservation | Experimental | Procedure: Infrapatellar Fat Pad preservationThe IPFP retention of more than 80% in actual operation shall be regarded as IPFP retention. |
| Infrapatellar Fat Pad Resection | Active comparator | Procedure: Infrapatellar Fat Pad resectionIn the clinical practice, more than 80% of IPFP volume is commonly resected by surgeons during total knee arthroplasty. The investigators hereby define resection of more than 80% IPFP volume as IPFP excision. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants diagnosed with knee osteoarthritis by X-ray plain film (Kellgren-Lawrence score of ≥ 2)
- The need for TKA was confirmed after evaluation by the orthopedic surgeon
- One week before surgery, knee pain 100mm pain visual analogue scale score was greater than 20mm
- Understanding of the study requirements and willing to participate in this study
Key exclusion criteria (8 listed)
- Rheumatoid arthritis,psoriatic arthritis,lupus,malignant tumor
- Requiring contralateral TKA within one year
- The visual analogue score of 100mm of knee pain before operation was less than 20mm
- Having a possible or planned pregnancy
- With poor compliance
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 |
|---|---|---|
| Infrapatellar Fat Pad preservationAlso: Infrapatellar fat pad retentionIn the IPFP preservation group, IPFP (more than 80%) will be preserved by retracting out of the operative field. | Procedure or surgery | Infrapatellar Fat Pad Preservation |
| Infrapatellar Fat Pad resectionIn the IPFP resection group, more than 80% IPFP will be resected during the total knee arthroplasty. | Procedure or surgery | Infrapatellar Fat Pad Resection |
Primary outcome
The mean score on five Knee Injury and Osteoarthritis Outcome Score(KOOS) subscales
Time frame: From pre-operation to 12 months after operation
The primary outcome was the change from baseline to 12 months in the mean score on five Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales, covering pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life (KOOS5), with scores ranging from 0 (worst) to 100 (best). The KOOS, a valid, reliable and responsive self-reported questionnaire applied to evaluate the short and long-term patient-relevant outcomes following TKA, consists of five subscales with a total of 42 items: pain (9 items), symptoms (7 items), function in ADL (17 items), sport and recreation function (5 items) and knee-related quality of life (4 items).
6 secondary outcomes
Five individual subscales of Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: From pre-operation to 12 months after operation
Knee Society Score(KSS)
Time frame: From pre-operation to 12 months after operation
Self-reported efficacy of reduced pain and increased quality of life
Time frame: From pre-operation to 12 months after operation
Insall - Salvati Ratio (ISR)
Time frame: From pre-operation to 12 months after operation
Timed Up and Go test
Time frame: From pre-operation to 12 months after operation
Visual Analogue Scale (VAS) Pain
Time frame: From pre-operation to 12 months after operation
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 5 Dec 2025.
- Derived from this study: PubMed 41874257Han W, Cao P, Cen H, Li B, Chen M, Li Y, Yang C, Lu M, Zhang H, Ke Y, Zhu Z, Liu X, Gao P, Zhou X, Liu Y, Dou Z, Liu Y, Zhang M, Lin J, Zha Z, Yin Z, Tian J, Lin L, Shang X, Hunter DJ, Liu J, Lei G, Ding C. Infrapatellar Fat Pad Preservation versus Resection in Total Knee Arthroplasty. NEJM Evid. 2026 Apr;5(4):EVIDoa2500135. doi: 10.1056/EVIDoa2500135. Epub 2026 Mar 24.
- Derived from this study: PubMed 33099502Zhu Z, Han W, Lu M, Lin J, Yin Z, Shang X, Weng X, Zha Z, Tian J, Lei G, Hunter DJ, Ding C. Effects of infrapatellar fat pad preservation versus resection on clinical outcomes after total knee arthroplasty in patients with knee osteoarthritis (IPAKA): study protocol for a multicentre, randomised, controlled clinical trial. BMJ Open. 2020 Oct 23;10(10):e043088. doi: 10.1136/bmjopen-2020-043088.
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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.
Changhai Ding, MD principal investigator
Clinical Research Center of Zhujiang Hospital,Southern Medical University
Jianhao Lin, MD principal investigator
Peking University People's Hospital
Xisheng Weng, MD principal investigator
Peking Union Medical College 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 Infrapatellar Fat Pad preservation and Infrapatellar Fat Pad resection in people with Knee Osteoarthritis and Arthropathy of Knee, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 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 5 Dec 2025. 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 China. 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?
The mean score on five Knee Injury and Osteoarthritis Outcome Score(KOOS) subscales (time frame: From pre-operation to 12 months after operation). 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 NCT03763448, which also lists 2 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 5 Dec 2025.