Knee OsteoarthritisNCT06135454
Comparison of Outcomes Between Open Wedge High Tibial Osteotomy and Double Level Osteotomy in Antromedial Knee Arthritis With Extra Articular Deformity
A study testing Open Wedge High Tibial Osteotomy and Double Level Osteotomy in people with Knee Osteoarthritis, run by Assiut University.
Trial summary
To compare the radiographic and clinical outcomes of varus osteoarthritic knees treated with an open-wedge high tibial osteotomy (OWHTO) alone or with a double-level osteotomy (DLO). Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Open Wedge High Tibial Osteotomy and Double Level Osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2024to 10 Dec 2026
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients that are indicated for surgery for medial compartment osteoarthritis only (medial joint line tenderness, varus tibiofemoral malalignment) with classification of Kellgren Lawrence grade (1/2/3)
- Age between 40 _ 60 years
- No associated bony fractures or deformities
- No associated ligamentous functional instability
- Varus more than or equal 15 degrees
Who cannot join
- Age younger than 40 or older than 60 years
- Secondary Arthritis (Inflammatory arthritis, post-traumatic osteoarthritis, active knee infection)
- Lateral Compartment OA or patellofemoral OA
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: Open Wedge High Tibial Osteotomy Versus Double Level Osteotomy
To compare the radiographic and clinical outcomes of varus osteoarthritic knees treated with an open-wedge high tibial osteotomy (OWHTO) alone or with a double-level osteotomy (DLO). It was hypothesized that treatment with DLO would prevent the joint line obliquity (JLO) , optimize post-operative limb alignment and provide better clinical and radiological outcomes after surgery than medial opening-wedge high tibial osteotomy (OWHTO) alone for patients with medial compartment osteoarthritis.
Read the detailed description
Osteoarthritis is a degenerative joint disease characterized by erosion of the articular cartilage, hypertrophy of the bone at the margins and subchondral sclerosis(1). Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to be varus deformity of the knee(2). High tibial osteotomy (HTO) is a well-established method for treatment of medial Uni compartmental-knee osteoarthritis and correction of varus deformity(3).Double level osteotomy recently used as another method for treatment this problem to improve outcomes and decrease complication(4).
- Conditions
- Knee Osteoarthritis
- Being tested
- Open Wedge High Tibial Osteotomy, Double Level Osteotomy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Wedge High Tibial OsteotomyProcedure or surgery
For OWHTO,The osteotomy plane, directed from 30 to 35 mm distal to the medial tibial plateau to 10-15 mm distal to the lateral tibial plateau in the coronal plane, was marked by two Kirschner wires with threaded tips. A transverse osteotomy was performed, leaving the lateral cortex intact as a hinge. After the ascending osteotomy and opening. The medial opening gap was filled with two β-TCP wedges and fixed with a TomoFix anatomical plate and locking screws .
Double Level OsteotomyProcedure or surgery
The DLO was started from a lateral DFO. A 5-6-cm incision was made proximally at the distal femur from the lateral femoral epicondyle.Two Kirschner wires with threaded tips were inserted to make a length between the wires that was preoperatively planned as the lateral closed osteotomy. Transverse and ascending osteotomies were performed using a Precision Oscillating Tip Saw. The gap was closed and fixed using a TomoFix medial distal femur anatomical plate , which was bent for the lateral distal femur. The subsequent OWHTO was performed as described above.
| Study group | Role | What they receive |
|---|---|---|
| Open Wedge High Tibial Osteotomy | Experimental | Not described Receives: Procedure: Open Wedge High Tibial Osteotomy |
| Double Level Osteotomy | Experimental | Not described Receives: Procedure: Open Wedge High Tibial Osteotomy; Procedure: Double Level Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of joint line obliquity (JLO) in the two groups.
Postoperative limb alignment using bilateral standing anteroposterior full-length views of both lower limbs
Measured: Preoperative , three months postoperative , one year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start10 Dec 2024 (estimated)
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abd Elgawad Mohamed Abd Elgawad Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135454
- Sponsor's protocol ID
- Knee Osteoarthritis
- Status last verified
- Feb 2024
- First submitted
- 13 Nov 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akamatsu Y, Nejima S, Tsuji M, Kobayashi H, Muramatsu S. Joint line obliquity was maintained after double-level osteotomy, but was increased after open-wedge high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2022 Feb;30(2):688-697. doi: 10.1007/s00167-020-06430-6. Epub 2021 Jan 12.
PubMed 33433634Babis GC, An KN, Chao EY, Rand JA, Sim FH. Double level osteotomy of the knee: a method to retain joint-line obliquity. Clinical results. J Bone Joint Surg Am. 2002 Aug;84(8):1380-8. doi: 10.2106/00004623-200208000-00013.
PubMed 12177268Schuster P, Rathgeb F, Mayer P, Michalski S, Hielscher L, Buchholz J, Kruger L, Richter J. Double level osteotomy for medial osteoarthritis and bifocal varus malalignment has excellent short-term results while maintaining physiologic radiographic joint parameters. Knee Surg Sports Traumatol Arthrosc. 2023 Aug;31(8):3124-3132. doi: 10.1007/s00167-022-07247-1. Epub 2022 Dec 10.
PubMed 36494478
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Wedge High Tibial Osteotomy Versus Double Level Osteotomy
- ClinicalTrials.gov ID
- NCT06135454
- Acronym / sponsor ID
- Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 18 Nov 2023 (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.
To compare the radiographic and clinical outcomes of varus osteoarthritic knees treated with an open-wedge high tibial osteotomy (OWHTO) alone or with a double-level osteotomy (DLO). It was hypothesized that treatment with DLO would prevent the joint line obliquity (JLO) , optimize post-operative limb alignment and provide better clinical and radiological outcomes after surgery than medial opening-wedge high tibial osteotomy (OWHTO) alone for patients with medial compartment osteoarthritis.
Detailed description
Osteoarthritis is a degenerative joint disease characterized by erosion of the articular cartilage, hypertrophy of the bone at the margins and subchondral sclerosis(1). Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to be varus deformity of the knee(2). High tibial osteotomy (HTO) is a well-established method for treatment of medial Uni compartmental-knee osteoarthritis and correction of varus deformity(3).Double level osteotomy recently used as another method for treatment this problem to improve outcomes and decrease complication(4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Wedge High Tibial Osteotomy | Experimental | Procedure: Open Wedge High Tibial Osteotomy |
| Double Level Osteotomy | Experimental | Procedure: Open Wedge High Tibial Osteotomy, Procedure: Double Level Osteotomy |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients that are indicated for surgery for medial compartment osteoarthritis only (medial joint line tenderness, varus tibiofemoral malalignment) with classification of Kellgren Lawrence grade (1/2/3)
- Age between 40 _ 60 years
- No associated bony fractures or deformities
- No associated ligamentous functional instability
- Varus more than or equal 15 degrees
Key exclusion criteria (3 listed)
- Age younger than 40 or older than 60 years
- Secondary Arthritis (Inflammatory arthritis, post-traumatic osteoarthritis, active knee infection)
- Lateral Compartment OA or patellofemoral OA
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 |
|---|---|---|
| Open Wedge High Tibial OsteotomyFor OWHTO,The osteotomy plane, directed from 30 to 35 mm distal to the medial tibial plateau to 10-15 mm distal to the lateral tibial plateau in the coronal plane, was marked by two Kirschner wires with threaded tips. A transverse osteotomy was performed, leaving the lateral cortex intact as a hinge. After the ascending osteotomy and opening. The medial opening gap was filled with two β-TCP wedges and fixed with a TomoFix anatomical plate and locking screws . | Procedure or surgery | Double Level Osteotomy, Open Wedge High Tibial Osteotomy |
| Double Level OsteotomyThe DLO was started from a lateral DFO. A 5-6-cm incision was made proximally at the distal femur from the lateral femoral epicondyle.Two Kirschner wires with threaded tips were inserted to make a length between the wires that was preoperatively planned as the lateral closed osteotomy. Transverse and ascending osteotomies were performed using a Precision Oscillating Tip Saw. The gap was closed and fixed using a TomoFix medial distal femur anatomical plate , which was bent for the lateral distal femur. The subsequent OWHTO was performed as described above. | Procedure or surgery | Double Level Osteotomy |
Primary outcome
Occurrence of joint line obliquity (JLO) in the two groups.
Time frame: Preoperative , three months postoperative , one year postoperative
Postoperative limb alignment using bilateral standing anteroposterior full-length views of both lower limbs
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 15 Feb 2024.
- Background: PubMed 33433634Akamatsu Y, Nejima S, Tsuji M, Kobayashi H, Muramatsu S. Joint line obliquity was maintained after double-level osteotomy, but was increased after open-wedge high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2022 Feb;30(2):688-697. doi: 10.1007/s00167-020-06430-6. Epub 2021 Jan 12.
- Background: PubMed 12177268Babis GC, An KN, Chao EY, Rand JA, Sim FH. Double level osteotomy of the knee: a method to retain joint-line obliquity. Clinical results. J Bone Joint Surg Am. 2002 Aug;84(8):1380-8. doi: 10.2106/00004623-200208000-00013.
- Background: PubMed 36494478Schuster P, Rathgeb F, Mayer P, Michalski S, Hielscher L, Buchholz J, Kruger L, Richter J. Double level osteotomy for medial osteoarthritis and bifocal varus malalignment has excellent short-term results while maintaining physiologic radiographic joint parameters. Knee Surg Sports Traumatol Arthrosc. 2023 Aug;31(8):3124-3132. doi: 10.1007/s00167-022-07247-1. Epub 2022 Dec 10.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Open Wedge High Tibial Osteotomy and Double Level Osteotomy in people with Knee Osteoarthritis, 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 5 inclusion and 3 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 15 Feb 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 Abd Elgawad Mohamed Abd Elgawad, Resident (00201003272019, abdelgawadmohamed@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of joint line obliquity (JLO) in the two groups. (time frame: Preoperative , three months postoperative , one year postoperative). 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 NCT06135454, which also lists 3 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 15 Feb 2024.