Osteoarthritis, KneeNCT04235283
Comparison of Pinless Navigation and Conventional Method in Total Knee Arthroplasty
A study testing Primary total knee replacement by pinless navigation (Orthomap Express,Stryker, Michigan) and Primary total knee replacement by traditional jig and minimally invasive technique in people with Osteoarthritis, Knee, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to conduct a prospective randomized clinical trial to compare the accuracy of prosthesis, radiographic alignment, total blood loss, the risk of venous thromboembolism between pinless-navigated total knee arthroplasty (TKA) and traditional TKA. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Primary total knee replacement by pinless navigation (Orthomap Express,Stryker, Michigan) and Primary total knee replacement by traditional jig and minimally invasive technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2019to 31 Dec 2020
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with osteoarthritis of the knee secondary to degeneration, inflammatory arthritis, gouty arthritis, posttraumatic arthritis, and undergoing primary unilateral minimally invasive TKA
- Age > 50 years and < 90 years
- Failure of medical treatment or rehabilitation.
- Hemoglobin > 11g/dl,
- No use of non-steroid anti-inflammatory agent one week before operation
Who cannot join
- Preoperative Hemoglobin <11 g/dl
- History of infection or intraarticular fracture of the affective knee
- Renal function deficiency (GFR <30 ml/min/1.73m2)
- Elevated liver enzyme (AST/ALT level are more than twice normal range) , history of liver cirrhosis, impaired liver function(elevated total bilirubin level) and coagulopathy (including long-term use anticoagulant)
- History of deep vein thrombosis, ischemic heart disease, cardiac arrythmia requiring life-long anti-coagulants, or stroke
- Contraindications of tranexamic acid, rivaroxaban, or the excipients
Show all 9Show fewer
- Allergy to tranexamic acid, rivaroxaban, or the excipients
- Coagulopathy or bleeding tendency caused by organ dysfunction, such as cirrhosis, bone marrow suppression etc.
- Patient who have active bleeding disorder, such as intracranial hemorrhage, upper GI bleeding, hematuria
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Jun-Wen Wang, MD, 886-7-7317123, wangjw@adm.cgmh.org.tw
About this study
Official title: Comparison of the Radiographic Outcomes and Total Blood Loss Between Pinless Navigation and Conventional Method in Minimally Invasive Total Knee Arthroplasty
The purpose of this study is to conduct a prospective randomized clinical trial to compare the accuracy of prosthesis, radiographic alignment, total blood loss, the risk of venous thromboembolism between pinless-navigated total knee arthroplasty (TKA) and traditional TKA.
Read the detailed description
Minimal invasive surgery total knee arthroplasty (MIS-TKA) is an excellent surgical procedure for patients with end-stage knee diseases and can reduce the postoperative complications compared with traditional TKA procedures.
However, MIS-TKA procedures require a long learning curve to avoid malposition of prosthesis. In previous studies have demonstrated that the position of prosthesis and the postoperative mechanical axis are critical factors of outcome. Malposition of prosthesis and deviation more than 3 degrees of mechanical axis will lead to asymmetrical tibia-femoral tracking between prosthesis with the wear of linear, and increase the incidence of prosthesis loosening.
Computer navigation assisted system has been used in TKA procedures for more than one decade and has been proven to improve the accuracy of prosthesis placement and postoperative mechanical alignment. Moreover, navigated TKA avoids the use of intramedullary guide and preserve the medullary cavity of femur, so the risks of bleeding and venous thromboembolism are reduced. However, traditional navigation system requires additional procedure to set reference arrays with pin fixation of femur and tibia. Pin wound complications including bleeding, infection, and iatrogenic fracture were reported. Moreover, traditional navigation system requires conventional TKA approach in which the wound length of the knee will be as long as 15 to 20 cm. Therefore a combination of new navigation system with a MIS technique to perform TKA procedure is required The new pinless navigated system for TKA procedures has been developed, as the navigation tools were fixed in the surgical field without additional pin wounds. This advantage meets the rationale of MIS-TKA to take care of both minimal invasive procedures and accuracy of prosthesis placement. Therefore, the investigators want to investigate the application of this pinless navigation system in MIS-TKA procedures.
Our purpose is to conduct a prospective randomized clinical trial to compare the accuracy of prosthesis, radiographic alignment, total blood loss, the risk of venous thromboembolism between pinless-navigated MIS-TKA and traditional MIS-TKA.
Material and Methods:
The investigators plan to enroll 100 patients who plan to undergo unilateral primary MIS-TKA and will be randomly assigned into two groups. The first group (50 patients) will be treated by pinless-navigation (Stryker, OrthoMap Express Knee Navigation) MIS-TKA, and the second group (50 patients) will undergo traditional MIS-TKA.
The investigators will record the surgical wound length, surgical time cost and calculate daily hemoglobin drainage and total blood loss after TKA procedures for all patients. At 3 months after operation, the whole leg scanography, AP and lat view of knee radiography will be take and the mechanical alignment (MA), anatomic alignment (AA), femoral bowing angle (FBA), and coronal femoral-component angle (CFA), coronal tibia-component angle (CTA) in coronary view and sagittal femoral component angle (SFA), sagittal tibial component angle (STA) in lateral view will be measured. The operating time and surgical wound length in knee full extension will be recorded. All complications including bleedings, wound complications, venous thromboembolism will be recorded.
Study year: one year Expecting Result The investigators anticipate that the position of prosthesis in pinless-navigated MIS-TKA is more accurate or equal to traditional MIS-TKA group. And the total blood loss in pinless-navigated MIS-TKA is less than traditional MIS-TKA group. The complication rate is similar between the two groups
- Conditions
- Osteoarthritis, Knee
- Being tested
- Primary total knee replacement by pinless navigation (Orthomap Express,Stryker, Michigan), Primary total knee replacement by traditional jig and minimally invasive technique
- Keywords
- Total knee arthroplasty, pinless, navigation, alignment, minimal invasive
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary total knee replacement by pinless navigation (Orthomap Express,Stryker, Michigan)Device
The varus/valgus, extension/flexion, thickness of distal cut of femur was determined and done by pinless navigation system. After cutting, the instant information of resection level can show on the display screen. If the alignment is satisfying, the anterior/posterior femoral cut, chamfer cut and box resection were done by conventional jig
Primary total knee replacement by traditional jig and minimally invasive techniqueProcedure or surgery
The femoral alignment was determined by intramedullary guide. The femoral alignment jig was set to 5-7 degree valgus dependent on the preoperative radiograph. A bone plug is impacted into the entry hole of femoral medullary canal before prosthesis placement.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Primary total knee replacement by pinless navigation and minimally invasive technique Receives: Device: Primary total knee replacement by pinless navigation (Orthomap Express,Stryker, Michigan) |
| Group II | Active comparator | Primary total knee replacement by traditional jig and minimally invasive technique Receives: Procedure: Primary total knee replacement by traditional jig and minimally invasive technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic outcome: the mechanical alignment (MA)
The mechanical alignment (MA): an angle between the mechanical axis of the femur and the tibial shaft axis
Measured: Three months after operation
Radiographic outcome: anatomic alignment (AA)
The anatomic alignment (AA): an angle between the axis of the femoral shaft and the tibial shaft axis
Measured: Three months after operation
Radiographic outcome: femoral bowing angle (FBA)
The femoral bowing angle (FBA): the angle between the distal and proximal femoral anatomical axes
Measured: Three months after operation
Radiographic outcome: coronal femoral-component angle (CFA)
Tthe angle between the femoral mechanical axis and the femoral component
Measured: Three months after operation
Radiographic outcome: coronal tibia-component angle (CTA)
The angle between the tibial shaft axis and the tibial component
Measured: Three months after operation
Secondary outcomes (6)
Total Blood Loss
The total blood loss was calculated according to Nadler et al., which uses maximum postoperative decrease of the Hb level adjusted for weight and height of the patient. Total blood loss consists of amount of blood loss calculated from the maximum Hb loss and amount of blood transfused
Measured: Postoperative Day 3
Blood transfusion rate
Record the event of blood transfusion, and calculate the incidence of transfusion
Measured: Three months after operation
Operating Time
Time needed for the surgical procedure (skin to skin) is recorded
Measured: After the procedure is done
Surgical wound length
The surgical wound length at full extension of knee is also recorded
Measured: After the procedure is done
Wound complications
Any wound complications including superficial infection, wound dehiscence, poor healing, etc. are all recorded
Measured: Three months after operation
Venous thromboembolism
perform duplex ultrasound study of both lower limbs in all patients on postoperative day 4
Measured: Postoperative Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 May 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (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 Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Model description
- Enroll 100 patients who plan to undergo unilateral primary MIS-TKA and will be randomly assigned into two groups. The first group (50 patients) will be treated by pinless-navigation (Stryker, OrthoMap Express Knee Navigation) MIS-TKA, and the second group (50 patients) will undergo traditional MIS-TKA.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun-Wen Wang, MD, Study director, Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235283
- Sponsor's protocol ID
- CMRPG8J0311
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zhang Z, Zhu W, Gu B, Zhu L, Chen C. Mini-midvastus versus mini-medial parapatellar approach in total knee arthroplasty: a prospective, randomized study. Arch Orthop Trauma Surg. 2013 Mar;133(3):389-95. doi: 10.1007/s00402-012-1645-x. Epub 2012 Dec 11.
PubMed 23229457Nestor BJ, Toulson CE, Backus SI, Lyman SL, Foote KL, Windsor RE. Mini-midvastus vs standard medial parapatellar approach: a prospective, randomized, double-blinded study in patients undergoing bilateral total knee arthroplasty. J Arthroplasty. 2010 Sep;25(6 Suppl):5-11, 11.e1. doi: 10.1016/j.arth.2010.04.003. Epub 2010 Jun 11.
PubMed 20541889Dalury DF, Dennis DA. Mini-incision total knee arthroplasty can increase risk of component malalignment. Clin Orthop Relat Res. 2005 Nov;440:77-81. doi: 10.1097/01.blo.0000185757.17401.7b.
PubMed 16239787Berend ME, Ritter MA, Meding JB, Faris PM, Keating EM, Redelman R, Faris GW, Davis KE. Tibial component failure mechanisms in total knee arthroplasty. Clin Orthop Relat Res. 2004 Nov;(428):26-34. doi: 10.1097/01.blo.0000148578.22729.0e.
PubMed 15534515King J, Stamper DL, Schaad DC, Leopold SS. Minimally invasive total knee arthroplasty compared with traditional total knee arthroplasty. Assessment of the learning curve and the postoperative recuperative period. J Bone Joint Surg Am. 2007 Jul;89(7):1497-503. doi: 10.2106/JBJS.F.00867.
PubMed 17606788Zhang Z, Gu B, Zhu W, Zhu L, Li Q, Du Y. Minimal invasive and computer-assisted total knee replacement compared with the minimal invasive technique: a prospective, randomized trial with short-term outcomes. Arch Orthop Trauma Surg. 2014 Jan;134(1):65-71. doi: 10.1007/s00402-013-1879-2. Epub 2013 Nov 8.
PubMed 24202408Seon JK, Song EK, Yoon TR, Park SJ, Bae BH, Cho SG. Comparison of functional results with navigation-assisted minimally invasive and conventional techniques in bilateral total knee arthroplasty. Comput Aided Surg. 2007 May;12(3):189-93. doi: 10.3109/10929080701311861.
PubMed 17538792Dutton AQ, Yeo SJ, Yang KY, Lo NN, Chia KU, Chong HC. Computer-assisted minimally invasive total knee arthroplasty compared with standard total knee arthroplasty. A prospective, randomized study. J Bone Joint Surg Am. 2008 Jan;90(1):2-9. doi: 10.2106/JBJS.F.01148.
PubMed 18171951Luring C, Beckmann J, Haibock P, Perlick L, Grifka J, Tingart M. Minimal invasive and computer assisted total knee replacement compared with the conventional technique: a prospective, randomised trial. Knee Surg Sports Traumatol Arthrosc. 2008 Oct;16(10):928-34. doi: 10.1007/s00167-008-0582-2. Epub 2008 Jul 17.
PubMed 18633597Hasegawa M, Yoshida K, Wakabayashi H, Sudo A. Minimally invasive total knee arthroplasty: comparison of jig-based technique versus computer navigation for clinical and alignment outcome. Knee Surg Sports Traumatol Arthrosc. 2011 Jun;19(6):904-10. doi: 10.1007/s00167-010-1253-7. Epub 2010 Sep 1.
PubMed 20811732Beldame J, Boisrenoult P, Beaufils P. Pin track induced fractures around computer-assisted TKA. Orthop Traumatol Surg Res. 2010 May;96(3):249-55. doi: 10.1016/j.otsr.2009.12.005. Epub 2010 Apr 8.
PubMed 20488143Hoke D, Jafari SM, Orozco F, Ong A. Tibial shaft stress fractures resulting from placement of navigation tracker pins. J Arthroplasty. 2011 Apr;26(3):504.e5-8. doi: 10.1016/j.arth.2010.05.009.
PubMed 20663640Berning ET, Fowler RM. Thermal damage and tracker-pin track infection in computer-navigated total knee arthroplasty. J Arthroplasty. 2011 Sep;26(6):977.e21-4. doi: 10.1016/j.arth.2010.08.012. Epub 2010 Oct 14.
PubMed 20950996Gulhane S, Holloway I, Bartlett M. A vascular complication in computer navigated total knee arthroplasty. Indian J Orthop. 2013 Jan;47(1):98-100. doi: 10.4103/0019-5413.106927.
PubMed 23531499Keyes BJ, Markel DC, Meneghini RM. Evaluation of limb alignment, component positioning, and function in primary total knee arthroplasty using a pinless navigation technique compared with conventional methods. J Knee Surg. 2013 Apr;26(2):127-32. doi: 10.1055/s-0032-1319788. Epub 2012 Jul 13.
PubMed 23288760
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Radiographic Outcomes and Total Blood Loss Between Pinless Navigation and Conventional Method in Minimally Invasive Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04235283
- Acronym / sponsor ID
- CMRPG8J0311
- Conditions
- Osteoarthritis, Knee
- Keywords
- Total knee arthroplasty, pinless, navigation, alignment, minimal invasive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 21 Jan 2020 (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 conduct a prospective randomized clinical trial to compare the accuracy of prosthesis, radiographic alignment, total blood loss, the risk of venous thromboembolism between pinless-navigated total knee arthroplasty (TKA) and traditional TKA.
Detailed description
Minimal invasive surgery total knee arthroplasty (MIS-TKA) is an excellent surgical procedure for patients with end-stage knee diseases and can reduce the postoperative complications compared with traditional TKA procedures.
However, MIS-TKA procedures require a long learning curve to avoid malposition of prosthesis. In previous studies have demonstrated that the position of prosthesis and the postoperative mechanical axis are critical factors of outcome. Malposition of prosthesis and deviation more than 3 degrees of mechanical axis will lead to asymmetrical tibia-femoral tracking between prosthesis with the wear of linear, and increase the incidence of prosthesis loosening.
Computer navigation assisted system has been used in TKA procedures for more than one decade and has been proven to improve the accuracy of prosthesis placement and postoperative mechanical alignment. Moreover, navigated TKA avoids the use of intramedullary guide and preserve the medullary cavity of femur, so the risks of bleeding and venous thromboembolism are reduced. However, traditional navigation system requires additional procedure to set reference arrays with pin fixation of femur and tibia. Pin wound complications including bleeding, infection, and iatrogenic fracture were reported. Moreover, traditional navigation system requires conventional TKA approach in which the wound length of the knee will be as long as 15 to 20 cm. Therefore a combination of new navigation system with a MIS technique to perform TKA procedure is required The new pinless navigated system for TKA procedures has been developed, as the navigation tools were fixed in the surgical field without additional pin wounds. This advantage meets the rationale of MIS-TKA to take care of both minimal invasive procedures and accuracy of prosthesis placement. Therefore, the investigators want to investigate the application of this pinless navigation system in MIS-TKA procedures.
Our purpose is to conduct a prospective randomized clinical trial to compare the accuracy of prosthesis, radiographic alignment, total blood loss, the risk of venous thromboembolism between pinless-navigated MIS-TKA and traditional MIS-TKA.
Material and Methods:
The investigators plan to enroll 100 patients who plan to undergo unilateral primary MIS-TKA and will be randomly assigned into two groups. The first group (50 patients) will be treated by pinless-navigation (Stryker, OrthoMap Express Knee Navigation) MIS-TKA, and the second group (50 patients) will undergo traditional MIS-TKA.
The investigators will record the surgical wound length, surgical time cost and calculate daily hemoglobin drainage and total blood loss after TKA procedures for all patients. At 3 months after operation, the whole leg scanography, AP and lat view of knee radiography will be take and the mechanical alignment (MA), anatomic alignment (AA), femoral bowing angle (FBA), and coronal femoral-component angle (CFA), coronal tibia-component angle (CTA) in coronary view and sagittal femoral component angle (SFA), sagittal tibial component angle (STA) in lateral view will be measured. The operating time and surgical wound length in knee full extension will be recorded. All complications including bleedings, wound complications, venous thromboembolism will be recorded.
Study year: one year Expecting Result The investigators anticipate that the position of prosthesis in pinless-navigated MIS-TKA is more accurate or equal to traditional MIS-TKA group. And the total blood loss in pinless-navigated MIS-TKA is less than traditional MIS-TKA group. The complication rate is similar between the two groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Enroll 100 patients who plan to undergo unilateral primary MIS-TKA and will be randomly assigned into two groups. The first group (50 patients) will be treated by pinless-navigation (Stryker, OrthoMap Express Knee Navigation) MIS-TKA, and the second group (50 patients) will undergo traditional MIS-TKA.
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Device: Primary total knee replacement by pinless navigation (Orthomap Express,Stryker, Michigan)Primary total knee replacement by pinless navigation and minimally invasive technique |
| Group II | Active comparator | Procedure: Primary total knee replacement by traditional jig and minimally invasive techniquePrimary total knee replacement by traditional jig and minimally invasive technique |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with osteoarthritis of the knee secondary to degeneration, inflammatory arthritis, gouty arthritis, posttraumatic arthritis, and undergoing primary unilateral minimally invasive TKA
- Age > 50 years and < 90 years
- Failure of medical treatment or rehabilitation.
- Hemoglobin > 11g/dl,
- No use of non-steroid anti-inflammatory agent one week before operation
Key exclusion criteria (9 listed)
- Preoperative Hemoglobin <11 g/dl
- History of infection or intraarticular fracture of the affective knee
- Renal function deficiency (GFR <30 ml/min/1.73m2)
- Elevated liver enzyme (AST/ALT level are more than twice normal range) , history of liver cirrhosis, impaired liver function(elevated total bilirubin level) and coagulopathy (including long-term use anticoagulant)
- History of deep vein thrombosis, ischemic heart disease, cardiac arrythmia requiring life-long anti-coagulants, or stroke
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 |
|---|---|---|
| Primary total knee replacement by pinless navigation (Orthomap Express,Stryker, Michigan)The varus/valgus, extension/flexion, thickness of distal cut of femur was determined and done by pinless navigation system. After cutting, the instant information of resection level can show on the display screen. If the alignment is satisfying, the anterior/posterior femoral cut, chamfer cut and box resection were done by conventional jig | Device | Group I |
| Primary total knee replacement by traditional jig and minimally invasive techniqueThe femoral alignment was determined by intramedullary guide. The femoral alignment jig was set to 5-7 degree valgus dependent on the preoperative radiograph. A bone plug is impacted into the entry hole of femoral medullary canal before prosthesis placement. | Procedure or surgery | Group II |
Primary outcome
Radiographic outcome: the mechanical alignment (MA)
Time frame: Three months after operation
The mechanical alignment (MA): an angle between the mechanical axis of the femur and the tibial shaft axis
Radiographic outcome: anatomic alignment (AA)
Time frame: Three months after operation
The anatomic alignment (AA): an angle between the axis of the femoral shaft and the tibial shaft axis
Radiographic outcome: femoral bowing angle (FBA)
Time frame: Three months after operation
The femoral bowing angle (FBA): the angle between the distal and proximal femoral anatomical axes
Radiographic outcome: coronal femoral-component angle (CFA)
Time frame: Three months after operation
Tthe angle between the femoral mechanical axis and the femoral component
Radiographic outcome: coronal tibia-component angle (CTA)
Time frame: Three months after operation
The angle between the tibial shaft axis and the tibial component
6 secondary outcomes
Total Blood Loss
Time frame: Postoperative Day 3
Blood transfusion rate
Time frame: Three months after operation
Operating Time
Time frame: After the procedure is done
Surgical wound length
Time frame: After the procedure is done
Wound complications
Time frame: Three months after operation
Venous thromboembolism
Time frame: Postoperative Day 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Background: PubMed 23229457Zhang Z, Zhu W, Gu B, Zhu L, Chen C. Mini-midvastus versus mini-medial parapatellar approach in total knee arthroplasty: a prospective, randomized study. Arch Orthop Trauma Surg. 2013 Mar;133(3):389-95. doi: 10.1007/s00402-012-1645-x. Epub 2012 Dec 11.
- Background: PubMed 20541889Nestor BJ, Toulson CE, Backus SI, Lyman SL, Foote KL, Windsor RE. Mini-midvastus vs standard medial parapatellar approach: a prospective, randomized, double-blinded study in patients undergoing bilateral total knee arthroplasty. J Arthroplasty. 2010 Sep;25(6 Suppl):5-11, 11.e1. doi: 10.1016/j.arth.2010.04.003. Epub 2010 Jun 11.
- Background: PubMed 16239787Dalury DF, Dennis DA. Mini-incision total knee arthroplasty can increase risk of component malalignment. Clin Orthop Relat Res. 2005 Nov;440:77-81. doi: 10.1097/01.blo.0000185757.17401.7b.
- Background: PubMed 15534515Berend ME, Ritter MA, Meding JB, Faris PM, Keating EM, Redelman R, Faris GW, Davis KE. Tibial component failure mechanisms in total knee arthroplasty. Clin Orthop Relat Res. 2004 Nov;(428):26-34. doi: 10.1097/01.blo.0000148578.22729.0e.
- Background: PubMed 17606788King J, Stamper DL, Schaad DC, Leopold SS. Minimally invasive total knee arthroplasty compared with traditional total knee arthroplasty. Assessment of the learning curve and the postoperative recuperative period. J Bone Joint Surg Am. 2007 Jul;89(7):1497-503. doi: 10.2106/JBJS.F.00867.
- Background: PubMed 24202408Zhang Z, Gu B, Zhu W, Zhu L, Li Q, Du Y. Minimal invasive and computer-assisted total knee replacement compared with the minimal invasive technique: a prospective, randomized trial with short-term outcomes. Arch Orthop Trauma Surg. 2014 Jan;134(1):65-71. doi: 10.1007/s00402-013-1879-2. Epub 2013 Nov 8.
- Background: PubMed 17538792Seon JK, Song EK, Yoon TR, Park SJ, Bae BH, Cho SG. Comparison of functional results with navigation-assisted minimally invasive and conventional techniques in bilateral total knee arthroplasty. Comput Aided Surg. 2007 May;12(3):189-93. doi: 10.3109/10929080701311861.
- Background: PubMed 18171951Dutton AQ, Yeo SJ, Yang KY, Lo NN, Chia KU, Chong HC. Computer-assisted minimally invasive total knee arthroplasty compared with standard total knee arthroplasty. A prospective, randomized study. J Bone Joint Surg Am. 2008 Jan;90(1):2-9. doi: 10.2106/JBJS.F.01148.
- Background: PubMed 18633597Luring C, Beckmann J, Haibock P, Perlick L, Grifka J, Tingart M. Minimal invasive and computer assisted total knee replacement compared with the conventional technique: a prospective, randomised trial. Knee Surg Sports Traumatol Arthrosc. 2008 Oct;16(10):928-34. doi: 10.1007/s00167-008-0582-2. Epub 2008 Jul 17.
- Background: PubMed 20811732Hasegawa M, Yoshida K, Wakabayashi H, Sudo A. Minimally invasive total knee arthroplasty: comparison of jig-based technique versus computer navigation for clinical and alignment outcome. Knee Surg Sports Traumatol Arthrosc. 2011 Jun;19(6):904-10. doi: 10.1007/s00167-010-1253-7. Epub 2010 Sep 1.
- Background: PubMed 20488143Beldame J, Boisrenoult P, Beaufils P. Pin track induced fractures around computer-assisted TKA. Orthop Traumatol Surg Res. 2010 May;96(3):249-55. doi: 10.1016/j.otsr.2009.12.005. Epub 2010 Apr 8.
- Background: PubMed 20663640Hoke D, Jafari SM, Orozco F, Ong A. Tibial shaft stress fractures resulting from placement of navigation tracker pins. J Arthroplasty. 2011 Apr;26(3):504.e5-8. doi: 10.1016/j.arth.2010.05.009.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun-Wen Wang, MD study director
Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial 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 Primary total knee replacement by pinless navigation (Orthomap Express,Stryker, Michigan) and Primary total knee replacement by traditional jig and minimally invasive technique in people with Osteoarthritis, Knee, run by Chang Gung Memorial Hospital 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 5 inclusion and 9 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 31 Jan 2020. 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 Shih-Hsiang Yen, MD (886-7-7317123 ext. 8003, yswings@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic outcome: the mechanical alignment (MA) (time frame: Three months after operation). The study lists 5 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 NCT04235283, 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 31 Jan 2020.