Distal Humerus FractureSPRINTNCT04748016
3D-printed Bone Models in Addition to CT Imaging for Intra-articular Fracture Repair
A study testing 3D printed (3DP) bone models + CT imaging and CT imaging in people with Distal Humerus Fracture and Distal Femur Fracture, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The purpose of this study is to compare the effectiveness of 3D-printed bone models in addition to CT imaging versus CT imaging alone on surgical quality and operation time for patients undergoing surgical repair of intra-articular fractures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Humerus Fracture, Distal Femur Fracture, Distal Tibia Fracture
- What is being tested?
- 3D printed (3DP) bone models + CT imaging and CT imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Mar 2020to 31 Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 years or older
- with intra-articular fracture of the proximal or distal humerus, proximal ulna, proximal radius, distal femur, or proximal or distal tibia (pilon fracture)
- requiring anticipated surgical repair of fracture
- with pre-operative CT scan already available as part of routine assessment
Who cannot join
- pathological fracture
- multiple fractures requiring simultaneous or staged operations
- fractures around the hip, pelvis and acetabulum, and any other fracture types not specified in the inclusion criteria
- requiring surgery within 24 hours of admission
- unable or unwilling to give consent to participate
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital, The University of Hong Kong
Hong Kong
Christian Xinshuo Fang, 22554581
Christian Xinshuo Fang
About this study
Official title: Sterilised 3D-PRINTed Bone Models in Addition to Conventional CT Imaging for Operative Visualisation in Complex Intra-articular Fracture Repair - A Multi-centre, Double-blind Randomised Controlled Trial
The purpose of this study is to compare the effectiveness of 3D-printed bone models in addition to CT imaging versus CT imaging alone on surgical quality and operation time for patients undergoing surgical repair of intra-articular fractures.
Read the detailed description
Surgical fixation of intra-articular fractures is a technically demanding task that poses significant challenges to orthopaedic surgeons. Articular fragments may be comminuted, depressed, or impacted, and neighbouring soft tissue is often heavily compromised. Furthermore, aggressive surgical dissection is typically necessary to achieve adequate visualisation, and anatomical reduction often devitalises bone fragments and invites deep infection. The management of intra-articular fractures requires a well-designed preoperative plan and a skilfully executed surgical tactic to guarantee the best possible outcome. Multiplanar reformation (CT-MPR) and three-dimensional reconstruction (CT-3DR) are imaging techniques that have enhanced intraoperative visualisation, however, accurate analysis of complex fractures remains challenging.
3D printing is a rapidly developing, low-cost technology that is already being applied across numerous contexts in orthopaedics and traumatology. 3D printed bone models can be produced from digitised CT data in a matter of hours, providing a dimensionally accurate representation of the patient's skeleton which approximates real-life visual and tactile experiences. When used in preoperative planning, these models have shown to improve surgeon communication and shorten surgical duration. Despite positive early results, few clinical studies have studied the effect of 3D bone model use on surgical outcome. The purpose of this randomised controlled trial is to compare the effectiveness of intraoperatively utilised 3D bone models in addition to conventional CT imaging on reduction quality and surgical duration versus CT imaging alone for patients undergoing surgical fixation of complex intraarticular fractures.
Patients providing informed consent will be screened for eligibility. All eligible patients will be randomly assigned in a double-blind manner (participant and outcome assessor) to receive surgical fracture fixation with or without the addition of sterilised 3D-printed bone models to standard CT imaging for intraoperative visualisation.
- Conditions
- Distal Humerus Fracture, Distal Femur Fracture, Distal Tibia Fracture, Proximal Humeral Fracture
- Being tested
- 3D printed (3DP) bone models + CT imaging, CT imaging
- Keywords
- 3D Printing, Intra-articular Fracture, Patient-specific instrumentation
- Medical subject headings
- Humeral Fractures, Distal, Femoral Fractures, Distal, Shoulder Fractures, Intra-Articular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed (3DP) bone models + CT imagingOther
In addition to CT-MPR and CT-3DR, 3DP models will be used for surgical planning and intraoperative visualization.
CT imagingOther
CT-MPR and CT-3DR used for surgical planning and intraoperative visualization.
| Study group | Role | What they receive |
|---|---|---|
| 3D-printed models plus CT imaging | Experimental | Fracture repair surgery using sterilized 3DP models, CT-MPR and CT-3DR for planning and intraoperative visualization Receives: Other: 3D printed (3DP) bone models + CT imaging |
| CT imaging alone | Active comparator | Fracture repair surgery using CT-MPR and CT-3DR for planning and intraoperative visualization Receives: Other: CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of articular surface reduction grading assessed by three-point scale
The quality of articular surface reduction will be rated by two surgeons blinded to intervention allotment assessing post-operative and intraoperative fluoroscopic images. The Kappa value will be recorded for inter-observer agreement between two observers (1. Perfect reduction, 2. Observable imperfections 1-2mm, 3. Significant imperfections >2mm)
Measured: Immediately post-operation
Skin to skin duration of surgery (minutes)
The skin to skin duration of the surgery will be recorded.
Measured: Immediately post-operation
Secondary outcomes (7)
Total fluoroscopy time (seconds)
The total intraoperative fluoroscopy time will be recorded in seconds.
Measured: Immediately post-operation
Intraoperative blood loss (mL)
The patient's blood loss during the surgery will be recorded.
Measured: Immediately post-operation
Total length of skin incision (mm)
The total length on the incision will be measured post operation.
Measured: Immediately post-operation
Total tourniquet time (minutes)
Total time the tourniquet was applied will be recorded.
Measured: Immediately post-operation
Incidence of surgical complications
Incidence of infection, neurological deficit, wound breakdown, loss of fixation, revision surgery will be recorded at follow up.
Measured: 3 months post-operation
Quality of articular surface reduction grading assessed by three-point scale
The quality of articular surface reduction will be rated by two surgeons blinded to intervention allotment assessing post-operative and intraoperative fluoroscopic images. The Kappa value will be recorded for inter-observer agreement between two observers (1. Perfect reduction, 2. Observable imperfections 1-2mm, 3. Significant imperfections >2mm)
Measured: 3 months post operation
Health-related quality of life measured by SF-12 Chinese (HK) version
12-item Short Form Health Survey (SF-12), a patient-reported outcome measure of HRQOL comprised of a mental component (MCS) and physical component (PCS), each with a final score ranging from 0 (worst outcome) to 100 (best outcome).
Measured: 3 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start13 Mar 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Distal Humerus FractureStudies of the same condition, open and under way.
- More trials run by The 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomised control trial with 40 patients in two interventional arm
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christian Xinshuo Fang, The University of Hong Kong
- Investigators
- Christian Fang, Principal investigator, Dept of Orthopaedics and Traumatology, Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748016
- Sponsor's protocol ID
- UW 18-480
- Acronym
- SPRINT
- Status last verified
- Jul 2022
- First submitted
- 5 Feb 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized dataset to be included as supplementary data in final publication
Publications
Jupiter JB, Fernandez DL, Toh CL, Fellman T, Ring D. Operative treatment of volar intra-articular fractures of the distal end of the radius. J Bone Joint Surg Am. 1996 Dec;78(12):1817-28. doi: 10.2106/00004623-199612000-00004.
PubMed 8986658Kang HW, Lee SJ, Ko IK, Kengla C, Yoo JJ, Atala A. A 3D bioprinting system to produce human-scale tissue constructs with structural integrity. Nat Biotechnol. 2016 Mar;34(3):312-9. doi: 10.1038/nbt.3413. Epub 2016 Feb 15.
PubMed 26878319You W, Liu LJ, Chen HX, Xiong JY, Wang DM, Huang JH, Ding JL, Wang DP. Application of 3D printing technology on the treatment of complex proximal humeral fractures (Neer3-part and 4-part) in old people. Orthop Traumatol Surg Res. 2016 Nov;102(7):897-903. doi: 10.1016/j.otsr.2016.06.009. Epub 2016 Aug 9.
PubMed 27521179Yang L, Shang XW, Fan JN, He ZX, Wang JJ, Liu M, Zhuang Y, Ye C. Application of 3D Printing in the Surgical Planning of Trimalleolar Fracture and Doctor-Patient Communication. Biomed Res Int. 2016;2016:2482086. doi: 10.1155/2016/2482086. Epub 2016 Jul 3.
PubMed 27446944Kacl GM, Zanetti M, Amgwerd M, Trentz O, Seifert B, Stucki H, Hodler J. Rapid prototyping (stereolithography) in the management of intra-articular calcaneal fractures. Eur Radiol. 1997;7(2):187-91. doi: 10.1007/s003300050132.
PubMed 9038112Yan CH, Chiu KY, Ng FY, Chan PK, Fang CX. Comparison between patient-specific instruments and conventional instruments and computer navigation in total knee arthroplasty: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2015 Dec;23(12):3637-45. doi: 10.1007/s00167-014-3264-2. Epub 2014 Sep 13.
PubMed 25217311Yang J, Cai H, Lv J, Zhang K, Leng H, Sun C, Wang Z, Liu Z. In vivo study of a self-stabilizing artificial vertebral body fabricated by electron beam melting. Spine (Phila Pa 1976). 2014 Apr 15;39(8):E486-92. doi: 10.1097/BRS.0000000000000211.
PubMed 24430723Peltola SM, Melchels FP, Grijpma DW, Kellomaki M. A review of rapid prototyping techniques for tissue engineering purposes. Ann Med. 2008;40(4):268-80. doi: 10.1080/07853890701881788.
PubMed 18428020Brown GA, Firoozbakhsh K, DeCoster TA, Reyna JR Jr, Moneim M. Rapid prototyping: the future of trauma surgery? J Bone Joint Surg Am. 2003;85-A Suppl 4:49-55. No abstract available.
PubMed 14652393Hurson C, Tansey A, O'Donnchadha B, Nicholson P, Rice J, McElwain J. Rapid prototyping in the assessment, classification and preoperative planning of acetabular fractures. Injury. 2007 Oct;38(10):1158-62. doi: 10.1016/j.injury.2007.05.020. Epub 2007 Sep 19.
PubMed 17884058Bizzotto N, Tami I, Tami A, Spiegel A, Romani D, Corain M, Adani R, Magnan B. 3D Printed models of distal radius fractures. Injury. 2016 Apr;47(4):976-8. doi: 10.1016/j.injury.2016.01.013. Epub 2016 Feb 6. No abstract available.
PubMed 26876530Li Z, Li Z, Xu R, Li M, Li J, Liu Y, Sui D, Zhang W, Chen Z. Three-dimensional printing models improve understanding of spinal fracture--A randomized controlled study in China. Sci Rep. 2015 Jun 23;5:11570. doi: 10.1038/srep11570.
PubMed 26099838Fang C, Fang B, Wong TM, Lau TW, Pun T, Leung F. Fixing a fractured arthrodesed hip with rapid prototype templating and minimal invasive plate osteosynthesis. Trauma Case Rep. 2015 Nov 14;1(9-12):79-83. doi: 10.1016/j.tcr.2015.10.005. eCollection 2015 Dec.
PubMed 30101181Wong TM, Jin J, Lau TW, Fang C, Yan CH, Yeung K, To M, Leung F. The use of three-dimensional printing technology in orthopaedic surgery. J Orthop Surg (Hong Kong). 2017 Jan;25(1):2309499016684077. doi: 10.1177/2309499016684077.
PubMed 28142354Fedorov A, Beichel R, Kalpathy-Cramer J, Finet J, Fillion-Robin JC, Pujol S, Bauer C, Jennings D, Fennessy F, Sonka M, Buatti J, Aylward S, Miller JV, Pieper S, Kikinis R. 3D Slicer as an image computing platform for the Quantitative Imaging Network. Magn Reson Imaging. 2012 Nov;30(9):1323-41. doi: 10.1016/j.mri.2012.05.001. Epub 2012 Jul 6.
PubMed 22770690
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sterilised 3D-PRINTed Bone Models in Addition to Conventional CT Imaging for Operative Visualisation in Complex Intra-articular Fracture Repair - A Multi-centre, Double-blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04748016
- Acronym / sponsor ID
- SPRINT / UW 18-480
- Conditions
- Distal Humerus Fracture, Distal Femur Fracture, Distal Tibia Fracture, Proximal Humeral Fracture
- Keywords
- 3D Printing, Intra-articular Fracture, Patient-specific instrumentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Feb 2021 (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 purpose of this study is to compare the effectiveness of 3D-printed bone models in addition to CT imaging versus CT imaging alone on surgical quality and operation time for patients undergoing surgical repair of intra-articular fractures.
Detailed description
Surgical fixation of intra-articular fractures is a technically demanding task that poses significant challenges to orthopaedic surgeons. Articular fragments may be comminuted, depressed, or impacted, and neighbouring soft tissue is often heavily compromised. Furthermore, aggressive surgical dissection is typically necessary to achieve adequate visualisation, and anatomical reduction often devitalises bone fragments and invites deep infection. The management of intra-articular fractures requires a well-designed preoperative plan and a skilfully executed surgical tactic to guarantee the best possible outcome. Multiplanar reformation (CT-MPR) and three-dimensional reconstruction (CT-3DR) are imaging techniques that have enhanced intraoperative visualisation, however, accurate analysis of complex fractures remains challenging.
3D printing is a rapidly developing, low-cost technology that is already being applied across numerous contexts in orthopaedics and traumatology. 3D printed bone models can be produced from digitised CT data in a matter of hours, providing a dimensionally accurate representation of the patient's skeleton which approximates real-life visual and tactile experiences. When used in preoperative planning, these models have shown to improve surgeon communication and shorten surgical duration. Despite positive early results, few clinical studies have studied the effect of 3D bone model use on surgical outcome. The purpose of this randomised controlled trial is to compare the effectiveness of intraoperatively utilised 3D bone models in addition to conventional CT imaging on reduction quality and surgical duration versus CT imaging alone for patients undergoing surgical fixation of complex intraarticular fractures.
Patients providing informed consent will be screened for eligibility. All eligible patients will be randomly assigned in a double-blind manner (participant and outcome assessor) to receive surgical fracture fixation with or without the addition of sterilised 3D-printed bone models to standard CT imaging for intraoperative visualisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomised control trial with 40 patients in two interventional arm
| Arm | Type | Receives |
|---|---|---|
| 3D-printed models plus CT imaging | Experimental | Other: 3D printed (3DP) bone models + CT imagingFracture repair surgery using sterilized 3DP models, CT-MPR and CT-3DR for planning and intraoperative visualization |
| CT imaging alone | Active comparator | Other: CT imagingFracture repair surgery using CT-MPR and CT-3DR for planning and intraoperative visualization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older
- with intra-articular fracture of the proximal or distal humerus, proximal ulna, proximal radius, distal femur, or proximal or distal tibia (pilon fracture)
- requiring anticipated surgical repair of fracture
- with pre-operative CT scan already available as part of routine assessment
Key exclusion criteria (5 listed)
- pathological fracture
- multiple fractures requiring simultaneous or staged operations
- fractures around the hip, pelvis and acetabulum, and any other fracture types not specified in the inclusion criteria
- requiring surgery within 24 hours of admission
- unable or unwilling to give consent to participate
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 |
|---|---|---|
| 3D printed (3DP) bone models + CT imagingIn addition to CT-MPR and CT-3DR, 3DP models will be used for surgical planning and intraoperative visualization. | Other | 3D-printed models plus CT imaging |
| CT imagingCT-MPR and CT-3DR used for surgical planning and intraoperative visualization. | Other | CT imaging alone |
Primary outcome
Quality of articular surface reduction grading assessed by three-point scale
Time frame: Immediately post-operation
The quality of articular surface reduction will be rated by two surgeons blinded to intervention allotment assessing post-operative and intraoperative fluoroscopic images. The Kappa value will be recorded for inter-observer agreement between two observers (1. Perfect reduction, 2. Observable imperfections 1-2mm, 3. Significant imperfections >2mm)
Skin to skin duration of surgery (minutes)
Time frame: Immediately post-operation
The skin to skin duration of the surgery will be recorded.
7 secondary outcomes
Total fluoroscopy time (seconds)
Time frame: Immediately post-operation
Intraoperative blood loss (mL)
Time frame: Immediately post-operation
Total length of skin incision (mm)
Time frame: Immediately post-operation
Total tourniquet time (minutes)
Time frame: Immediately post-operation
Incidence of surgical complications
Time frame: 3 months post-operation
Quality of articular surface reduction grading assessed by three-point scale
Time frame: 3 months post operation
Health-related quality of life measured by SF-12 Chinese (HK) version
Time frame: 3 months post-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 8986658Jupiter JB, Fernandez DL, Toh CL, Fellman T, Ring D. Operative treatment of volar intra-articular fractures of the distal end of the radius. J Bone Joint Surg Am. 1996 Dec;78(12):1817-28. doi: 10.2106/00004623-199612000-00004.
- Background: PubMed 26878319Kang HW, Lee SJ, Ko IK, Kengla C, Yoo JJ, Atala A. A 3D bioprinting system to produce human-scale tissue constructs with structural integrity. Nat Biotechnol. 2016 Mar;34(3):312-9. doi: 10.1038/nbt.3413. Epub 2016 Feb 15.
- Background: PubMed 27521179You W, Liu LJ, Chen HX, Xiong JY, Wang DM, Huang JH, Ding JL, Wang DP. Application of 3D printing technology on the treatment of complex proximal humeral fractures (Neer3-part and 4-part) in old people. Orthop Traumatol Surg Res. 2016 Nov;102(7):897-903. doi: 10.1016/j.otsr.2016.06.009. Epub 2016 Aug 9.
- Background: PubMed 27446944Yang L, Shang XW, Fan JN, He ZX, Wang JJ, Liu M, Zhuang Y, Ye C. Application of 3D Printing in the Surgical Planning of Trimalleolar Fracture and Doctor-Patient Communication. Biomed Res Int. 2016;2016:2482086. doi: 10.1155/2016/2482086. Epub 2016 Jul 3.
- Background: PubMed 9038112Kacl GM, Zanetti M, Amgwerd M, Trentz O, Seifert B, Stucki H, Hodler J. Rapid prototyping (stereolithography) in the management of intra-articular calcaneal fractures. Eur Radiol. 1997;7(2):187-91. doi: 10.1007/s003300050132.
- Background: PubMed 25217311Yan CH, Chiu KY, Ng FY, Chan PK, Fang CX. Comparison between patient-specific instruments and conventional instruments and computer navigation in total knee arthroplasty: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2015 Dec;23(12):3637-45. doi: 10.1007/s00167-014-3264-2. Epub 2014 Sep 13.
- Background: PubMed 24430723Yang J, Cai H, Lv J, Zhang K, Leng H, Sun C, Wang Z, Liu Z. In vivo study of a self-stabilizing artificial vertebral body fabricated by electron beam melting. Spine (Phila Pa 1976). 2014 Apr 15;39(8):E486-92. doi: 10.1097/BRS.0000000000000211.
- Background: PubMed 18428020Peltola SM, Melchels FP, Grijpma DW, Kellomaki M. A review of rapid prototyping techniques for tissue engineering purposes. Ann Med. 2008;40(4):268-80. doi: 10.1080/07853890701881788.
- Background: PubMed 14652393Brown GA, Firoozbakhsh K, DeCoster TA, Reyna JR Jr, Moneim M. Rapid prototyping: the future of trauma surgery? J Bone Joint Surg Am. 2003;85-A Suppl 4:49-55. No abstract available.
- Background: PubMed 17884058Hurson C, Tansey A, O'Donnchadha B, Nicholson P, Rice J, McElwain J. Rapid prototyping in the assessment, classification and preoperative planning of acetabular fractures. Injury. 2007 Oct;38(10):1158-62. doi: 10.1016/j.injury.2007.05.020. Epub 2007 Sep 19.
- Background: PubMed 26876530Bizzotto N, Tami I, Tami A, Spiegel A, Romani D, Corain M, Adani R, Magnan B. 3D Printed models of distal radius fractures. Injury. 2016 Apr;47(4):976-8. doi: 10.1016/j.injury.2016.01.013. Epub 2016 Feb 6. No abstract available.
- Background: PubMed 26099838Li Z, Li Z, Xu R, Li M, Li J, Liu Y, Sui D, Zhang W, Chen Z. Three-dimensional printing models improve understanding of spinal fracture--A randomized controlled study in China. Sci Rep. 2015 Jun 23;5:11570. doi: 10.1038/srep11570.
- Individual participant dataSharing planned: Yes. Anonymized dataset to be included as supplementary data in final publication
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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.
Christian Fang principal investigator
Dept of Orthopaedics and Traumatology, Queen Mary 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 3D printed (3DP) bone models + CT imaging and CT imaging in people with Distal Humerus Fracture and Distal Femur Fracture, run by The 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 4 inclusion and 5 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 20 Jul 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.
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 Christian Fang (22554581, cfang@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of articular surface reduction grading assessed by three-point scale (time frame: Immediately post-operation). The study lists 2 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 NCT04748016, which also lists 18 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 20 Jul 2022.