An interventional study of Mako4 Robotic Arm Assisted Total Knee Arthroplasty and conventional total knee arthroplasty using Triathlon Total Knee System in Osteoarthritis (Knee) and Robotic Assisted Arthroplasty, sponsored by Ain Shams University. Not yet recruiting at 1 site in Egypt. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
Among 91 studies in Osteoarthritis, Knee with a site in Egypt — 28 open to participants now, 34 under way, 1 of them phase 3. Osteoarthritis, Knee · Egypt.
Among the 91 studies in Osteoarthritis, Knee with a site in Egypt, this one is the 33rd largest by planned enrollment of the 83 interventional ones, is one of 15 that started in 2026, is one of 76 with no phase, reaches primary completion later than 33 of the 33 other live ones, and was the 89th registered.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 70 is close to the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →28 of the 91 studies in Osteoarthritis, Knee with a site in Egypt are open now, in 1 country. Each count lists the studies.
Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →91 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 15 started in 2026.
Median enrollment 62 across the 83 interventional studies, 69 across the 8 observational. Of the 50 that completed or were terminated, 0 (0%) have results posted.
None of the 91 has an industry lead sponsor. The 10 most frequent:
Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Ain Shams University has 7 studies filed under Osteoarthritis, Knee — fewer than ten, so there is no comparison to draw.
12 of the studies in Osteoarthritis, Knee with a site in Egypt that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07047040Phase 3Assiut UniversityAnalgesic Efficacy of Pre-operative Dose of Ketorolac and Gabapentin | 2027-10-30 |
| NCT07664371Tanta UniversityCryoneurolysis Versus Radiofrequency in Knee Osteoarthritis | 2026-11 |
| NCT07774195Cairo UniversityEfficacy of AI-Driven and Traditional Physical Therapy Programs in Patients With Knee Osteoarthritis | 2026-11-21 |
| NCT07468734German International UniversityShock Wave Versus Traditional Physical Therapy for Adult Chronic Knee Osteoarthritis | 2026-11-30 |
| NCT07666347Tanta UniversityIntraarticular Injection of Botox and Hyaluronic Acid in Knee Osteoarthritis | 2026-12-01 |
Among the 91 studies in Osteoarthritis, Knee with a site in Egypt, from their registry updates:
Total knee arthroplasty (TKA) remains the definitive treatment for advanced knee osteoarthritis and continues to be performed with increasing frequency worldwide. However, patient dissatisfaction remains reported in up to one-fifth of cases, despite technically successful procedures and acceptable radiographic results. This discrepancy has shifted attention toward early functional recovery and patient-reported outcomes as more meaningful indicators of success. In response, technological innovations such as robotic-assisted total knee arthroplasty have been introduced to enhance surgical precision and reduce alignment outliers. This study aims to determine whether these technical advantages translate into improved early clinical outcomes by comparing patient satisfaction, functional results, radiological accuracy, and perioperative parameters between robotic-assisted and conventional total knee arthroplasty over one year.
Two-arm, parallel-group, randomized controlled trial comparing Mako4 robotic-arm assisted total knee arthroplasty with conventional total knee arthroplasty. Participants will be allocated in a 1:1 ratio using simple computer-generated randomization. Allocation will be concealed by an off-site holder of the randomization sequence who is independent of participant enrollment and outcome assessment. Outcome assessors will be blinded to treatment allocation, while participants and the operating surgical team will not be blinded because of the nature of the interventions.
Group A: Conventional Total Knee Arthroplasty (C-TKA). Group B: Robotic-Assisted Total Knee Arthroplasty (RA-TKA).
I. Primary (Preoperative) Diagnosis and Evaluation:
A. Clinical Evaluation
history
General examination:
local examination
B. Radiological Evaluation:
PLAIN FILMS
Standing long-leg radiographs, obtained with the patellae facing forward and the feet flat on the ground
Overall, Limb Alignment
Femoral and tibial Parameters
Joint-Related Angles
Deformity Analysis
C. preoperative patient preparation:
II. intraoperative management:
All patients will be managed by the same surgical team following a standardized perioperative protocol. Surgery will be performed with the patient in the supine position. Prophylactic intravenous antibiotics will be administered 30 minutes prior to skin incision in accordance with hospital policy, using weight-adjusted dosing.
Above-knee pneumatic tourniquet will be applied in all cases. A standard medial parapatellar approach will be utilized. Total knee arthroplasty will be performed either using a conventional manual jig-based technique (C-TKA) (Group A) with a Fixed-bearing Posterior- Stabilized (PS) implants or robotic-assisted total knee arthroplasty (RA-TKA) (Group B), according to patient allocation. All implants and instrumentation will be provided by the same company (STRYKER).
Regardless of surgical technique, all TKAs will be performed using cemented fixation. Stem extensions will be selectively used on a case-by-case basis in the presence of obesity, osteoporosis, or significant bone defects. The patella will be managed with conventional patelloplasty in all patients. Closed-suction drains will be used routinely.
III. Postoperative management and follow up:
A. Rehab and medications:
All patients will receive the same
B. Radiological study:
With follow up at 6 weeks, 3months , 6 months and 1 year.
C. Computed tomography (CT) of the operated knee will be performed in the immediate postoperative period to assess femoral and tibial component rotational alignment and overall implant rotational profile.
D. Functional score At follow-up visits, the FJS-12, OKS, and ((2011 KSS) objective knee parameters, Symptoms, Functional Activities, fulfilled Expectations, and Satisfaction domains) will be recorded at 6 weeks, 3 months, 6 months, and 1 year and compared between both groups throughout follow-up.
E. Complications will be monitored and managed accordingly, e.g.: DVT, infection, periprosthetic fracture, implant loosening or failure .
Statistical Analysis:
By using Power Analysis and Sample Size Software (PASS 15) (Version 15.0.10) for sample size calculation, with a power of 80% and a significance level of 0.05, based on previous study results (Bollars et al., 2025), which reported that among patients undergoing total knee arthroplasty (TKA), patient satisfaction measured by FJS-12 was higher in those who underwent robotic-assisted TKA (mean 73.2 ± 23.3) compared to conventional instrumented TKA (mean 53.6 ± 29.0), and accounting for a 10% dropout rate; a sample size of at least 70 patients presenting with symptomatic end-stage primary knee osteoarthritis divided randomly into 2 groups (35 patients in each group) will be needed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients will be managed by the same surgical team , performed with the patient in supine position. Prophylactic intravenous antibiotics will be administered 30 minutes before skin incision , using weight-adjusted dosing. An above-knee pneumatic tourniquet will be applied in all cases, and a standard medial parapatellar approach will be used. Patients allocated to the robotic-assisted group will undergo total knee arthroplasty using the Mako Robotic-Arm Assisted System (Stryker, Kalamazoo, Michigan, USA) with the Triathlon Total Knee System. Robotic assistance will be used for preoperative/intraoperative surgical planning, bone preparation, component positioning, and intraoperative assessment of soft-tissue balance. In both groups, all components will be implanted using cemented fixation. Stem extensions may be used selectively on a case-by-case basis.The patella will be managed with conventional patelloplasty in all patients. Closed-suction drains will be used routinely.
Device: Mako4 Robotic Arm Assisted Total Knee Arthroplasty
All patients will be managed by the same surgical team , performed with the patient in supine position. Prophylactic intravenous antibiotics will be administered 30 minutes before skin incision , using weight-adjusted dosing. An above-knee pneumatic tourniquet will be applied in all cases, and a standard medial parapatellar approach will be used. Patients allocated to the conventional (control) group will undergo total knee arthroplasty using the Triathlon Total Knee System (Stryker, Kalamazoo, Michigan, USA) with standard manual instrumentation and conventional cutting jigs, without robotic assistance. Component sizing, bone preparation, positioning, and soft-tissue balancing will be performed using standard conventional techniques. All components will be implanted using cemented fixation. Stem extensions may be used selectively on a case-by-case basis. The patella will be managed with conventional patelloplasty in all patients. Closed-suction drains will be used routinely.
Procedure: conventional total knee arthroplasty using Triathlon Total Knee System
All patients will be managed by the same surgical team , performed with the patient in supine position. Prophylactic intravenous antibiotics will be administered 30 minutes before skin incision , using weight-adjusted dosing. An above-knee pneumatic tourniquet will be applied in all cases, and a standard medial parapatellar approach will be used. Patients allocated to the robotic-assisted group will undergo total knee arthroplasty using the Mako Robotic-Arm Assisted System (Stryker, Kalamazoo, Michigan, USA) with the Triathlon Total Knee System. Robotic assistance will be used for preoperative/intraoperative surgical planning, bone preparation, component positioning, and intraoperative assessment of soft-tissue balance. In both groups, all components will be implanted using cemented fixation. Stem extensions may be used selectively on a case-by-case basis.The patella will be managed with conventional patelloplasty in all patients. Closed-suction drains will be used routinely.
Also known as: Mako 4 SmartRobotics™, Mako 4.0, Stryker Mako 4, Mako Fourth Generation System
All patients will be managed by the same surgical team , performed with the patient in supine position. Prophylactic intravenous antibiotics will be administered 30 minutes before skin incision , using weight-adjusted dosing. An above-knee pneumatic tourniquet will be applied in all cases, and a standard medial parapatellar approach will be used. Patients allocated to the conventional (control) group will undergo total knee arthroplasty using the Triathlon Total Knee System (Stryker, Kalamazoo, Michigan, USA) with standard manual instrumentation and conventional cutting jigs, without robotic assistance. Component sizing, bone preparation, positioning, and soft-tissue balancing will be performed using standard conventional techniques. All components will be implanted using cemented fixation. Stem extensions may be used selectively on a case-by-case basis. The patella will be managed with conventional patelloplasty in all patients. Closed-suction drains will be used routinely.
Also known as: Manual Triathlon TKA:, Conventional Total Knee Arthroplasty (TKA), Triathlon Primary Total Knee System, Jig-based Total Knee Arthroplasty (TKA)
patient satisfaction (Forgotten Joint Score-12 (FJS-12))
Patient-reported joint awareness assessed using the 12-item Forgotten Joint Score (FJS-12). The score ranges from 0 to 100, with higher scores indicating less awareness of the operated knee during daily activities and therefore a better outcome.
Time frame: 6 weeks, 3 months, 6 months, and 12 months postoperatively
Patient Satisfaction (2011 Knee Society Score [KSS] Satisfaction Domain)
Patient satisfaction will be assessed using the satisfaction domain of the 2011 Knee Society Score. Scores range from 0 to 40, with higher scores indicating greater patient satisfaction and therefore a better outcome.
Time frame: 6 weeks, 3 months, 6 months, and 12 months postoperatively
Functional outcome: (2011 Knee Society Score [KSS] Symptoms Domain)
Symptoms will be assessed using the symptoms domain of the 2011 Knee Society Score (KSS). Scores range from 0 to 25, with higher scores indicating fewer symptoms and a better outcome.
Time frame: 6 weeks, 3 months, 6 months, and 12 months postoperatively
Functional outcome: (2011 Knee Society Score [KSS] Functional Activity Domain)
Functional activity will be assessed using the functional activity domain of the 2011 Knee Society Score (KSS). Scores range from 0 to 100, with higher scores indicating better functional ability.
Time frame: 6 weeks, 3 months, 6 months, and 12 months postoperatively
Functional outcome: (2011 Knee Society Score [KSS] Expectations Domain)
Patient expectations will be assessed using the expectations domain of the 2011 Knee Society Score (KSS). Scores range from 0 to 15, with higher scores indicating greater fulfillment of patient expectations.
Time frame: 6 weeks, 3 months, 6 months, and 12 months postoperatively
Functional outcome: (2011 Knee Society Score [KSS] objective knee indicators domain )
Objective knee status will be assessed using the Objective Knee Score of the 2011 Knee Society Score (KSS), which evaluates symptoms, range of motion, knee stability, and alignment. Scores range from 0 to 100, with higher scores indicating better objective knee status.
Time frame: 6 weeks, 3 months, 6 months, and 12 months postoperatively
Functional Outcome: (Oxford Knee Score [OKS])
Functional outcome will be assessed using the Oxford Knee Score (OKS), a 12-item patient-reported measure evaluating knee pain and function. Scores range from 0 to 48, with higher scores indicating better knee function and less pain.
Time frame: 6 weeks, 3 months, 6 months, and 12 months postoperatively
Radiological accuracy: Hip-Knee-Ankle angle (HKA)
Coronal lower-limb alignment will be assessed on standing full-length lower-limb radiographs using the hip-knee-ankle (HKA) angle, measured in degrees. The HKA angle will be determined from the mechanical axes of the femur and tibia. Deviation from the prespecified alignment target will also be recorded. An alignment outlier will be defined according to the prespecified study threshold, including deviation greater than 3 degrees from the intended alignment target where applicable.
Time frame: 6 weeks postoperatively
Radiological accuracy: Knee Society Radiographic Evaluation System (KSRES)
Postoperative radiographs will be obtained (Xray knees Ap, lateral and if applicable; merchant view) and will be assessed using the Knee Society Radiographic Evaluation System, which provides a standardized assessment of total knee arthroplasty component alignment and fixation. Radiolucent lines and osteolysis will be recorded according to predefined femoral and tibial component zones, and component position will be assessed in the coronal and sagittal planes.
Time frame: immediate postoperative , 6 months and and 12 months postoperatively
Femoral Component Rotational Alignment
Femoral component rotational alignment will be assessed using postoperative computed tomography (CT). Rotation will be measured in degrees relative to the predefined femoral anatomical reference axis. The magnitude and direction of rotational deviation will be recorded.
Time frame: immediate postoperative
Tibial component rotational alignment
Tibial component rotational alignment will be assessed using postoperative computed tomography (CT). Rotation will be measured in degrees relative to the predefined tibial anatomical reference axis. The magnitude and direction of rotational deviation will be recorded.
Time frame: immediate postoperative
Patellar Height
Patellar height will be assessed on standardized lateral knee radiographs using the Caton-Deschamps Index (CDI). The index is calculated as the ratio between the distance from the inferior edge of the patellar articular surface to the anterosuperior angle of the tibial plateau and the length of the patellar articular surface. Higher values indicate a relatively higher patellar position.
Time frame: Immediate postoperative period, 6 months, and 12 months postoperatively
Operative Time (minutes)
Total operative time will be recorded in minutes from skin incision to completion of skin closure.
Time frame: Intraoperative
perioperative Blood Loss
Measured perioperative blood loss will be calculated as the sum of estimated intraoperative blood loss (calculated from suction canister volume after subtraction of irrigation fluid plus gravimetric assessment of blood absorbed by surgical swabs and sponges.) and cumulative postoperative closed-suction drain output, expressed in milliliters.
Time frame: From the start of surgery until drain removal, typically within 24-48 hours postoperatively
Requirement for Soft-Tissue Release
The number and proportion of participants requiring one or more soft-tissue releases during total knee arthroplasty to achieve satisfactory ligament balance will be recorded. and also , the specific soft-tissue structure or structures released to achieve ligament balance will be recorded. These may include the medial collateral ligament, posteromedial capsule, posterior capsule, iliotibial band, lateral collateral ligament, popliteus tendon, or other periarticular soft-tissue structures as clinically indicated.
Time frame: Intraoperative
Final Polyethylene Insert Thickness
The thickness of the final implanted polyethylene tibial insert will be recorded in millimeters.
Time frame: Intraoperative
intraoperative and postoperative Blood transfusion (Packed RBCS units)
The number and proportion of participants receiving packed red blood cell transfusion during the intraoperative or postoperative period will be recorded.
Time frame: From the start of surgery through hospital discharge
Length of Hospital Stay ( days)
Duration of postoperative hospitalization will be measured in days from the date of surgery until hospital discharge.
Time frame: From surgery through hospital discharge
Incidence of infection
( prosthetic joint infection ) PJI will be diagnosed according to the 2018 evidence-based International Consensus Meeting (ICM) criteria, based on the presence of a major criterion or fulfillment of the validated weighted minor-criteria scoring system.
Time frame: through study completion, an average of 1 year follow up
periprosthetic fractures
Time frame: From the perioperative period through study completion, up to atleast 12 months postoperatively
neurovascular compromise
Time frame: From the perioperative period through study completion, up to atleast 12 months postoperatively
Deep Vein Thrombosis (DVT)
The number and proportion of participants developing postoperative deep vein thrombosis will be recorded. DVT will be diagnosed based on clinical suspicion confirmed by appropriate vascular imaging, such as duplex ultrasonography, according to institutional practice.
Time frame: From the perioperative period through study completion, up to atleast 12 months postoperatively
Need for Revision or Reoperation for Implant-Related Failure
The number and proportion of participants experiencing failure of the implanted total knee arthroplasty components will be recorded. Implant failure will include mechanical failure, clinically significant component loosening, breakage, instability, or any implant-related complication requiring revision or reoperation.
Time frame: From the perioperative period through study completion, up to atleast 12 months postoperatively
Plan to share: Yes — De-identified individual participant data underlying the published results may be made available upon reasonable request to the principal investigator, subject to approval by the Institutional Review Board of the Faculty of Medicine, Ain Shams University and applicable institutional data-sharing policies. No directly identifiable participant information will be shared
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data may be made available after publication of the primary study results and for a period of 2 years thereafter.
Access criteria: Access will be considered for qualified researchers who submit a scientifically justified request, a proposed analysis plan, and evidence of ethics approval where required. Requests will be reviewed by the principal investigator and, where necessary, the Institutional Review Board of the Faculty of Medicine, Ain Shams University. Access may be subject to a data-use agreement and approval based on the scientific merit of the request and protection of participant confidentiality.
Start is estimated for Oct 2026; primary completion for Apr 2028, 18 months later.
Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 18 months is close to that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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