Osteoarthritis (OA) of the KneerKA-KA-TKANCT06726993
Comparison of Restricted Versus Unrestricted Kinematic Alignment in 1ry TKA
A study testing Total knee arthroplasty in people with Osteoarthritis (OA) of the Knee and Total Knee Anthroplasty, run by Assiut University.
Trial summary
Knee osteoarthritis is a growing socioeconomic burden because of the ageing and obesity. By 2030, the majority of individuals undergoing knee arthroplasty in USA will be those younger than 65 years, with up to 1 million achieved annually. The definitive treatment for knee joint degeneration is total knee arthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis (OA) of the Knee, Total Knee Anthroplasty
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -Patients suffered from end stage knee osteoarthritis of grade four according to Kellgren-Lawrence classification in at least one of the three knee compartments, who have an osteoarthritic knees of varus Coronal Plane Alignment of the Knee classification
Who cannot join
- Any valgus malalignment of the knee joint.
- Malalignment more than 10° or less than 3° varus of knee joint.
- Ligamentous laxity of the affected knee (medial or lateral collateral ligaments)
- any tumors or secondary neoplasia diseases
- Knee joint infection
- severe cardiopulmonary dysfunction.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Restricted Kinematic Alignment Versus Unrestricted Kinematic Alignment in Primary Total Knee Arthroplasty:- Randomized Controlled Trial
Knee osteoarthritis is a growing socioeconomic burden because of the ageing and obesity. By 2030, the majority of individuals undergoing knee arthroplasty in USA will be those younger than 65 years, with up to 1 million achieved annually.
The definitive treatment for knee joint degeneration is total knee arthroplasty.
Read the detailed description
Furthermore, the commonest technique is neutral mechanical alignment total knee arthroplasty. Latest studies have revealed that the mechanical alignment technique repeatedly causing substantial anatomical alterations with a widespread of complex collateral ligament imbalances, which are not repairable by collateral ligament release. Consequently, the total knee arthroplasty individuals walk with an abnormal gait, and they do not experience a normal knee joint. This may be one of the causes that up to 20% of total knee arthroplasty individuals are disappointed, and over 50% may have remaining symptoms.
Consequently, the conventional mechanical alignment technique has been recently challenged by a new alternative technique, namely unrestricted kinematic alignment proposed by Howell, as a possible solution to the high dissatisfaction following total knee arthroplasty, aiming at reproducing the constitutional tibiofemoral tridimensional alignment and knee laxity. It is almost a pure bone procedure with only exceptional collateral ligament release, which has been shown to reliably position knee components.
The restricted kinematic alignment protocol suggested by Vendittoli has been developed as an alternative to the unrestricted kinematic alignment for patients with an outlier or atypical knee anatomy. The restricted kinematic alignment is founded on five principles: hip-knee-ankle angle should be maintained within ± 3° postoperatively; a limitation to a maximum of 5° for lateral distal femoral angle and medial proximal tibial angle may be considered; restoration of collateral ligament balance should be achieved without the gap balancing technique; native femoral anatomy preservation is suggested over tibial one to maintain knee biomechanics; resurface resection must be accomplished on the unworn side with a thickness equivalent to the width of the implant;cut fine-tuning may be sought at the worn side.
- Being tested
- Total knee arthroplasty
- Keywords
- Total knee arthroplasty, TKA, Total knee replacement, TKR, Restricted kinematic alignment, rKA, Kinematic alignment, KA, Unrestricted kinematic alignment
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
Also called Total knee replacement
Total knee arthroplasty (TKA) is a common orthopaedic surgery that involves replacing the articular surfaces (femoral condyles and tibial plateau) of the knee joint with smooth metal and highly cross-linked polyethylene plastic
| Study group | Role | What they receive |
|---|---|---|
| Unrestricted kinematic alignment | Experimental | reproducing the constitutional tibiofemoral tridimensional alignment and knee laxity. It is almost a pure bone procedure with only exceptional collateral ligament release, which has been shown to reliably position knee components. |
| Restricted kinematic alignment | Experimental | reproducing patient's constitutional knee anatomy within a safe range while avoiding extreme or pathological anatomies that have been demonstrated to exist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxoford knee score
The Oxford Knee Score is a 12-item patient-reported outcomes specifically designed and developed to assess function and pain after total knee replacement arthroplasty. It is short, reproducible, valid and sensitive to clinically important changes.
Score each question from 0 to 4 with 4 being the best outcome. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome
Measured: 12 months
Secondary outcomes (2)
Knee Injury and Osteoarthritis Outcome Score
The Knee Injury and Osteoarthritis Outcome Score is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The questionnaire is self-administered and assesses five outcomes: pain(9 items), symptoms(7 items), activities of daily living(17 items), sport and recreation function(5 items), and knee-related quality of life (4 items). The questionnaire meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome.
A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Measured: 24 months
Forgotten Joint Score
The Forgotten Joint Score was designed to assess patient outcome in patients undergoing conservative or operative treatment of the knee. This questionnaire shows its strengths in patients with a good level of knee function and a low pain level. It has been designed specifically to reduce ceiling effects commonly associated with many patients reported outcome measures in this patient group, e.g. when assessing short- to mid-term results in total knee arthroplasty patients.
Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score.
Final score = 100 - ((sum(item01 to item12) - 12)/48*100) For the final 'Forgotten Joint Score -12' a high score indicates good outcome.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Feb 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sohibe Abdulazeem Ghietah Hussein, Assiut University
- Investigators
- Sohibe A Ghietah, Specialist, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726993
- Sponsor's protocol ID
- 04-2024-100320
- Acronym
- rKA-KA-TKA
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Howell SM HM. Kinematic alignment in TKA: definition, surgical technique, and challenging cases.. Orthopedic Knowledge Online. 2012; 10(7).
Risitano S, Cacciola G, Sabatini L, Capella M, Bosco F, Giustra F, Masse A, Vaishya R. Restricted kinematic alignment in primary total knee arthroplasty: A systematic review of radiographic and clinical data. J Orthop. 2022 Jul 2;33:37-43. doi: 10.1016/j.jor.2022.06.014. eCollection 2022 Sep-Oct.
PubMed 35812351Albishi W, AbuDujain NM, Arafah O, Alshaygy IS, Aldosari ZA, Alhuqbani MN, Alangari SM. Cross-cultural adaptation, validity and reliability of the Arabic version of the Forgotten Joint Score for knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2023 Oct;31(10):4312-4318. doi: 10.1007/s00167-023-07484-y. Epub 2023 Jun 17.
PubMed 37329371Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13.
PubMed 22000572Almangoush A, Herrington L, Attia I, Jones R, Aldawoudy A, Abdul Aziz A, Waley A. Cross-cultural adaptation, reliability, internal consistency and validation of the Arabic version of the knee injury and osteoarthritis outcome score (KOOS) for Egyptian people with knee injuries. Osteoarthritis Cartilage. 2013 Dec;21(12):1855-64. doi: 10.1016/j.joca.2013.09.010. Epub 2013 Oct 2.
PubMed 24095836Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.
PubMed 9699158Ahmed KM, Said HG, Ramadan EKA, Abd El-Radi M, El-Assal MA. Arabic translation and validation of three knee scores, Lysholm Knee Score (LKS), Oxford Knee Score (OKS), and International Knee Documentation Committee Subjective Knee Form (IKDC). SICOT J. 2019;5:6. doi: 10.1051/sicotj/2018054. Epub 2019 Mar 8.
PubMed 30848244Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br. 1998 Jan;80(1):63-9. doi: 10.1302/0301-620x.80b1.7859.
PubMed 9460955MacDessi SJ, Griffiths-Jones W, Harris IA, Bellemans J, Chen DB. Coronal Plane Alignment of the Knee (CPAK) classification. Bone Joint J. 2021 Feb;103-B(2):329-337. doi: 10.1302/0301-620X.103B2.BJJ-2020-1050.R1.
PubMed 33517740Vendittoli PA, Martinov S, Blakeney WG. Restricted Kinematic Alignment, the Fundamentals, and Clinical Applications. Front Surg. 2021 Jul 20;8:697020. doi: 10.3389/fsurg.2021.697020. eCollection 2021.
PubMed 34355018Hutt JR, LeBlanc MA, Masse V, Lavigne M, Vendittoli PA. Kinematic TKA using navigation: Surgical technique and initial results. Orthop Traumatol Surg Res. 2016 Feb;102(1):99-104. doi: 10.1016/j.otsr.2015.11.010. Epub 2016 Jan 6.
PubMed 26776100Ranawat AS, Ranawat CS, Elkus M, Rasquinha VJ, Rossi R, Babhulkar S. Total knee arthroplasty for severe valgus deformity. J Bone Joint Surg Am. 2005 Sep;87 Suppl 1(Pt 2):271-84. doi: 10.2106/JBJS.E.00308.
PubMed 16140800Howell SM, Howell SJ, Hull ML. Assessment of the radii of the medial and lateral femoral condyles in varus and valgus knees with osteoarthritis. J Bone Joint Surg Am. 2010 Jan;92(1):98-104. doi: 10.2106/JBJS.H.01566.
PubMed 20048101Bellemans J, Colyn W, Vandenneucker H, Victor J. The Chitranjan Ranawat award: is neutral mechanical alignment normal for all patients? The concept of constitutional varus. Clin Orthop Relat Res. 2012 Jan;470(1):45-53. doi: 10.1007/s11999-011-1936-5.
PubMed 21656315Nam D, Nunley RM, Barrack RL. Patient dissatisfaction following total knee replacement: a growing concern? Bone Joint J. 2014 Nov;96-B(11 Supple A):96-100. doi: 10.1302/0301-620X.96B11.34152.
PubMed 25381418
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Restricted Kinematic Alignment Versus Unrestricted Kinematic Alignment in Primary Total Knee Arthroplasty:- Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06726993
- Acronym / sponsor ID
- rKA-KA-TKA / 04-2024-100320
- Keywords
- Total knee arthroplasty, TKA, Total knee replacement, TKR, Restricted kinematic alignment, rKA, Kinematic alignment, KA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 10 Dec 2024 (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.
Knee osteoarthritis is a growing socioeconomic burden because of the ageing and obesity. By 2030, the majority of individuals undergoing knee arthroplasty in USA will be those younger than 65 years, with up to 1 million achieved annually.
The definitive treatment for knee joint degeneration is total knee arthroplasty.
Detailed description
Furthermore, the commonest technique is neutral mechanical alignment total knee arthroplasty. Latest studies have revealed that the mechanical alignment technique repeatedly causing substantial anatomical alterations with a widespread of complex collateral ligament imbalances, which are not repairable by collateral ligament release. Consequently, the total knee arthroplasty individuals walk with an abnormal gait, and they do not experience a normal knee joint. This may be one of the causes that up to 20% of total knee arthroplasty individuals are disappointed, and over 50% may have remaining symptoms.
Consequently, the conventional mechanical alignment technique has been recently challenged by a new alternative technique, namely unrestricted kinematic alignment proposed by Howell, as a possible solution to the high dissatisfaction following total knee arthroplasty, aiming at reproducing the constitutional tibiofemoral tridimensional alignment and knee laxity. It is almost a pure bone procedure with only exceptional collateral ligament release, which has been shown to reliably position knee components.
The restricted kinematic alignment protocol suggested by Vendittoli has been developed as an alternative to the unrestricted kinematic alignment for patients with an outlier or atypical knee anatomy. The restricted kinematic alignment is founded on five principles: hip-knee-ankle angle should be maintained within ± 3° postoperatively; a limitation to a maximum of 5° for lateral distal femoral angle and medial proximal tibial angle may be considered; restoration of collateral ligament balance should be achieved without the gap balancing technique; native femoral anatomy preservation is suggested over tibial one to maintain knee biomechanics; resurface resection must be accomplished on the unworn side with a thickness equivalent to the width of the implant;cut fine-tuning may be sought at the worn side.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unrestricted kinematic alignment | Experimental | –reproducing the constitutional tibiofemoral tridimensional alignment and knee laxity. It is almost a pure bone procedure with only exceptional collateral ligament release, which has been shown to reliably position knee components. |
| Restricted kinematic alignment | Experimental | –reproducing patient's constitutional knee anatomy within a safe range while avoiding extreme or pathological anatomies that have been demonstrated to exist. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients suffered from end stage knee osteoarthritis of grade four according to Kellgren-Lawrence classification in at least one of the three knee compartments, who have an osteoarthritic knees of varus Coronal Plane Alignment of the Knee classification
Key exclusion criteria (6 listed)
- Any valgus malalignment of the knee joint.
- Malalignment more than 10° or less than 3° varus of knee joint.
- Ligamentous laxity of the affected knee (medial or lateral collateral ligaments)
- any tumors or secondary neoplasia diseases
- Knee joint infection
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 |
|---|---|---|
| Total knee arthroplastyAlso: Total knee replacementTotal knee arthroplasty (TKA) is a common orthopaedic surgery that involves replacing the articular surfaces (femoral condyles and tibial plateau) of the knee joint with smooth metal and highly cross-linked polyethylene plastic | Procedure or surgery | – |
Primary outcome
Oxoford knee score
Time frame: 12 months
The Oxford Knee Score is a 12-item patient-reported outcomes specifically designed and developed to assess function and pain after total knee replacement arthroplasty. It is short, reproducible, valid and sensitive to clinically important changes. Score each question from 0 to 4 with 4 being the best outcome. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome
2 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score
Time frame: 24 months
Forgotten Joint Score
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Results publicationHowell SM HM. Kinematic alignment in TKA: definition, surgical technique, and challenging cases.. Orthopedic Knowledge Online. 2012; 10(7).
- Results publication: PubMed 35812351Risitano S, Cacciola G, Sabatini L, Capella M, Bosco F, Giustra F, Masse A, Vaishya R. Restricted kinematic alignment in primary total knee arthroplasty: A systematic review of radiographic and clinical data. J Orthop. 2022 Jul 2;33:37-43. doi: 10.1016/j.jor.2022.06.014. eCollection 2022 Sep-Oct.
- Results publication: PubMed 37329371Albishi W, AbuDujain NM, Arafah O, Alshaygy IS, Aldosari ZA, Alhuqbani MN, Alangari SM. Cross-cultural adaptation, validity and reliability of the Arabic version of the Forgotten Joint Score for knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2023 Oct;31(10):4312-4318. doi: 10.1007/s00167-023-07484-y. Epub 2023 Jun 17.
- Results publication: PubMed 22000572Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13.
- Results publication: PubMed 24095836Almangoush A, Herrington L, Attia I, Jones R, Aldawoudy A, Abdul Aziz A, Waley A. Cross-cultural adaptation, reliability, internal consistency and validation of the Arabic version of the knee injury and osteoarthritis outcome score (KOOS) for Egyptian people with knee injuries. Osteoarthritis Cartilage. 2013 Dec;21(12):1855-64. doi: 10.1016/j.joca.2013.09.010. Epub 2013 Oct 2.
- Results publication: PubMed 9699158Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.
- Results publication: PubMed 30848244Ahmed KM, Said HG, Ramadan EKA, Abd El-Radi M, El-Assal MA. Arabic translation and validation of three knee scores, Lysholm Knee Score (LKS), Oxford Knee Score (OKS), and International Knee Documentation Committee Subjective Knee Form (IKDC). SICOT J. 2019;5:6. doi: 10.1051/sicotj/2018054. Epub 2019 Mar 8.
- Results publication: PubMed 9460955Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br. 1998 Jan;80(1):63-9. doi: 10.1302/0301-620x.80b1.7859.
- Results publication: PubMed 33517740MacDessi SJ, Griffiths-Jones W, Harris IA, Bellemans J, Chen DB. Coronal Plane Alignment of the Knee (CPAK) classification. Bone Joint J. 2021 Feb;103-B(2):329-337. doi: 10.1302/0301-620X.103B2.BJJ-2020-1050.R1.
- Results publication: PubMed 34355018Vendittoli PA, Martinov S, Blakeney WG. Restricted Kinematic Alignment, the Fundamentals, and Clinical Applications. Front Surg. 2021 Jul 20;8:697020. doi: 10.3389/fsurg.2021.697020. eCollection 2021.
- Results publication: PubMed 26776100Hutt JR, LeBlanc MA, Masse V, Lavigne M, Vendittoli PA. Kinematic TKA using navigation: Surgical technique and initial results. Orthop Traumatol Surg Res. 2016 Feb;102(1):99-104. doi: 10.1016/j.otsr.2015.11.010. Epub 2016 Jan 6.
- Results publication: PubMed 16140800Ranawat AS, Ranawat CS, Elkus M, Rasquinha VJ, Rossi R, Babhulkar S. Total knee arthroplasty for severe valgus deformity. J Bone Joint Surg Am. 2005 Sep;87 Suppl 1(Pt 2):271-84. doi: 10.2106/JBJS.E.00308.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoarthritis (OA) of the Knee
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
Recruiting
Pharmacist-physiotherapist Collaborative Management for Early Knee Osteoarthritis
Osteoarthritis (OA) of the Knee, Physiotherapy
RecruitingPhase 4
Personalized Analgesia Through Central Nervous System Engagement to Unlock Performance
Knee Osteoarthritis (Knee OA), Chronic Pain
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.
Sohibe A Ghietah, Specialist principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty in people with Osteoarthritis (OA) of the Knee and Total Knee Anthroplasty, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 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: opening soon, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaser E Khalifa, Professor (+201005673622, yaserkhalifa@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxoford knee score (time frame: 12 months). 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 NCT06726993, which also lists 21 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 19 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.