Osteo Arthritis KneeNCT04541342
Arthroscopic Evaluation of Cartilage Regeneration After Opening-wedge High Tibial Osteotomy
A study testing initial arthroscopy with medial opening-wedge high tibial osteotomy fixed by a plate system then second look arthroscopy with plate removal in people with Osteo Arthritis Knee, run by Assiut University at 2 sites in Egypt.
Trial summary
Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to by varus deformity of the knee. High tibial osteotomy is a well-established method for treatment of medial unicompartmental knee osteoarthritis and correction of varus… Read more about this study
- Who is it for?
- Ages Up to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- initial arthroscopy with medial opening-wedge high tibial osteotomy fixed by a plate system then second look arthroscopy with plate removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Sep 2020to 31 Jan 2024
- 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 Up to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age younger than 65 years
- Medial joint line tenderness
- BMI less than 30
- Varus tibiofemoral malalignment
- Range of motion in the knee joint maintained from greater than 100 degrees of flexion to less than 15 degrees of flexion contracture
- Osteoarthritis of the knee with any degree of cartilage damage provided that the cartilage damage in the lateral compartment not exceeding Outerbridge grade 2
- No associated ligamentous functional instability
Who cannot join
- Age older than 65 years
- Severe Lateral compartment osteoarthritis (Outerbridge grade 3 or 4)
- Flexion contracture of greater than 15 degrees
- Inflammatory arthritis, post-traumatic osteoarthritis, active knee infection
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Second-look Arthroscopic Evaluation of Cartilage Regeneration After Medial Opening-wedge High Tibial Osteotomy
Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to by varus deformity of the knee. High tibial osteotomy is a well-established method for treatment of medial unicompartmental knee osteoarthritis and correction of varus deformity.
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. Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to by varus deformity of the knee. High tibial osteotomy is a well-established method for treatment of medial unicompartmental knee osteoarthritis and correction of varus deformity. It is a joint preserving procedure especially preferred in young patients for whom arthroplasty is not desirable. The procedure promotes regeneration by causing lateral shift of the weight-bearing axis, thus decreasing load on the medial compartment and widening the medial joint space. The methods for اigh tibial osteotomy include opening-wedge osteotomy and closed wedge osteotomy. An opening-wedge osteotomy has become increasingly popular compared to the other technique. One of the disadvantages of this technique is that the plate is placed subcutaneously on the medial aspect of the proximal tibia. Many of the patients complains of irritation through the plate and wish metal removal after healing of the osteotomy. Few papers assessed regeneration of the articular cartilage after medial opening-wedge osteotomy.
- Conditions
- Osteo Arthritis Knee
- Being tested
- initial arthroscopy with medial opening-wedge high tibial osteotomy fixed by a plate system then second look arthroscopy with plate removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
initial arthroscopy with medial opening-wedge high tibial osteotomy fixed by a plate system then second look arthroscopy with plate removalProcedure or surgery
It is a joint preserving procedure especially preferred in young patients for whom arthroplasty is not desirable. The procedure promotes regeneration by causing lateral shift of the weight-bearing axis, thus decreasing load on the medial compartment and widening the medial joint space.Many of the patients complains of irritation through the plate and wish metal removal after healing of the osteotomy.All patients will undergo initial arthroscopy before high tibial osteotomy (HTO). During arthroscopy, debridement of the degenerate tissues and meniscal tears if present will be performed. Then opening-wedge high tibial osteotomy (OWHTO) will be performed and fixed by a plate system. Second-look arthroscopy will be conducted at the time of plate removal after healing of the osteotomy. This will be after about 6 months up to one year.
| Study group | Role | What they receive |
|---|---|---|
| osteoarthritic with genu varus | Experimental | initial arthroscopy and high tibial osteotomy to be followed later by a second look arthroscopy with plate removal Receives: Procedure: initial arthroscopy with medial opening-wedge high tibial osteotomy fixed by a plate system then second look arthroscopy with plate removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arthroscopic assessment of cartilage regeneration after high tibial osteotomy
By use of Outerbridge classification of chondral lesions during arthroscopy, comparison will be made between cartilage status before and after high tibial osteotomy according to the Outerbrigde classification which classifies cartilage lesions into grades of 0 through IV. Grade 0 signifies normal cartilage.
Grade I chondral lesions are characterized by softening and swelling, which often require tactile feedback with a probe or other instrument to assess. Grade II lesion describes a partial-thickness defect with fissures that do not exceed 0.5 inches in diameter or reach subchondral bone.
Grade III is fissuring of the cartilage with a diameter > 0.5 inches with an area reaching subchondral bone.
The most severe is Grade IV, which includes erosion of the articular cartilage that exposes subchondral bone.
Measured: 6 months after high tibial osteotomy
Secondary outcomes (1)
Post-operative limb alignment
by use of bilateral standing anteroposterior full-length views of both lower limbs before high tibial osteotomy and at time of plate removal. The tibiofemoral angle will be measured to detect the degree of varus correction.
Measured: 6 months after high tibial osteotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Sep 2020
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis 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
- Not applicable
- Intervention model
- Single group
- Model description
- quasi experimental one group pretest posttest study design
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Sayed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541342
- Sponsor's protocol ID
- arthroscopy with HTO
- Status last verified
- Jul 2024
- First submitted
- 28 Aug 2020
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim KI, Seo MC, Song SJ, Bae DK, Kim DH, Lee SH. Change of Chondral Lesions and Predictive Factors After Medial Open-Wedge High Tibial Osteotomy With a Locked Plate System. Am J Sports Med. 2017 Jun;45(7):1615-1621. doi: 10.1177/0363546517694864. Epub 2017 Mar 14.
PubMed 28291955Slattery C, Kweon CY. Classifications in Brief: Outerbridge Classification of Chondral Lesions. Clin Orthop Relat Res. 2018 Oct;476(10):2101-2104. doi: 10.1007/s11999.0000000000000255. No abstract available.
PubMed 29533246Koshino T, Wada S, Ara Y, Saito T. Regeneration of degenerated articular cartilage after high tibial valgus osteotomy for medial compartmental osteoarthritis of the knee. Knee. 2003 Sep;10(3):229-36. doi: 10.1016/s0968-0160(03)00005-x.
PubMed 12893144AbdelKawi AF, El-Assal MA, Abdelhamid MM, Sayed AM. Arthroscopic evidence of improvement in cartilage lesions after medial opening-wedge high-tibial osteotomy with valgus correction and its positive impact on clinical outcomes, a prospective study. Int Orthop. 2025 Aug;49(8):1879-1885. doi: 10.1007/s00264-025-06552-x. Epub 2025 Jun 2.
PubMed 40455268
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second-look Arthroscopic Evaluation of Cartilage Regeneration After Medial Opening-wedge High Tibial Osteotomy
- ClinicalTrials.gov ID
- NCT04541342
- Acronym / sponsor ID
- arthroscopy with HTO
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 9 Sep 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.
Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to by varus deformity of the knee. High tibial osteotomy is a well-established method for treatment of medial unicompartmental knee osteoarthritis and correction of varus deformity.
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. Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to by varus deformity of the knee. High tibial osteotomy is a well-established method for treatment of medial unicompartmental knee osteoarthritis and correction of varus deformity. It is a joint preserving procedure especially preferred in young patients for whom arthroplasty is not desirable. The procedure promotes regeneration by causing lateral shift of the weight-bearing axis, thus decreasing load on the medial compartment and widening the medial joint space. The methods for اigh tibial osteotomy include opening-wedge osteotomy and closed wedge osteotomy. An opening-wedge osteotomy has become increasingly popular compared to the other technique. One of the disadvantages of this technique is that the plate is placed subcutaneously on the medial aspect of the proximal tibia. Many of the patients complains of irritation through the plate and wish metal removal after healing of the osteotomy. Few papers assessed regeneration of the articular cartilage after medial opening-wedge osteotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- quasi experimental one group pretest posttest study design
| Arm | Type | Receives |
|---|---|---|
| osteoarthritic with genu varus | Experimental | Procedure: initial arthroscopy with medial opening-wedge high tibial osteotomy fixed by a plate system then second look arthroscopy with plate removalinitial arthroscopy and high tibial osteotomy to be followed later by a second look arthroscopy with plate removal |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age younger than 65 years
- Medial joint line tenderness
- BMI less than 30
- Varus tibiofemoral malalignment
- Range of motion in the knee joint maintained from greater than 100 degrees of flexion to less than 15 degrees of flexion contracture
Key exclusion criteria (4 listed)
- Age older than 65 years
- Severe Lateral compartment osteoarthritis (Outerbridge grade 3 or 4)
- Flexion contracture of greater than 15 degrees
- Inflammatory arthritis, post-traumatic osteoarthritis, active knee 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 |
|---|---|---|
| initial arthroscopy with medial opening-wedge high tibial osteotomy fixed by a plate system then second look arthroscopy with plate removalIt is a joint preserving procedure especially preferred in young patients for whom arthroplasty is not desirable. The procedure promotes regeneration by causing lateral shift of the weight-bearing axis, thus decreasing load on the medial compartment and widening the medial joint space.Many of the patients complains of irritation through the plate and wish metal removal after healing of the osteotomy.All patients will undergo initial arthroscopy before high tibial osteotomy (HTO). During arthroscopy, debridement of the degenerate tissues and meniscal tears if present will be performed. Then opening-wedge high tibial osteotomy (OWHTO) will be performed and fixed by a plate system. Second-look arthroscopy will be conducted at the time of plate removal after healing of the osteotomy. This will be after about 6 months up to one year. | Procedure or surgery | osteoarthritic with genu varus |
Primary outcome
Arthroscopic assessment of cartilage regeneration after high tibial osteotomy
Time frame: 6 months after high tibial osteotomy
By use of Outerbridge classification of chondral lesions during arthroscopy, comparison will be made between cartilage status before and after high tibial osteotomy according to the Outerbrigde classification which classifies cartilage lesions into grades of 0 through IV. Grade 0 signifies normal cartilage. Grade I chondral lesions are characterized by softening and swelling, which often require tactile feedback with a probe or other instrument to assess. Grade II lesion describes a partial-thickness defect with fissures that do not exceed 0.5 inches in diameter or reach subchondral bone. Grade III is fissuring of the cartilage with a diameter > 0.5 inches with an area reaching subchondral bone. The most severe is Grade IV, which includes erosion of the articular cartilage that exposes subchondral bone.
1 secondary outcome
Post-operative limb alignment
Time frame: 6 months after high tibial osteotomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 28291955Kim KI, Seo MC, Song SJ, Bae DK, Kim DH, Lee SH. Change of Chondral Lesions and Predictive Factors After Medial Open-Wedge High Tibial Osteotomy With a Locked Plate System. Am J Sports Med. 2017 Jun;45(7):1615-1621. doi: 10.1177/0363546517694864. Epub 2017 Mar 14.
- Background: PubMed 29533246Slattery C, Kweon CY. Classifications in Brief: Outerbridge Classification of Chondral Lesions. Clin Orthop Relat Res. 2018 Oct;476(10):2101-2104. doi: 10.1007/s11999.0000000000000255. No abstract available.
- Background: PubMed 12893144Koshino T, Wada S, Ara Y, Saito T. Regeneration of degenerated articular cartilage after high tibial valgus osteotomy for medial compartmental osteoarthritis of the knee. Knee. 2003 Sep;10(3):229-36. doi: 10.1016/s0968-0160(03)00005-x.
- Derived from this study: PubMed 40455268AbdelKawi AF, El-Assal MA, Abdelhamid MM, Sayed AM. Arthroscopic evidence of improvement in cartilage lesions after medial opening-wedge high-tibial osteotomy with valgus correction and its positive impact on clinical outcomes, a prospective study. Int Orthop. 2025 Aug;49(8):1879-1885. doi: 10.1007/s00264-025-06552-x. Epub 2025 Jun 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing initial arthroscopy with medial opening-wedge high tibial osteotomy fixed by a plate system then second look arthroscopy with plate removal in people with Osteo Arthritis Knee, run by Assiut University at 2 sites in Egypt.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arthroscopic assessment of cartilage regeneration after high tibial osteotomy (time frame: 6 months after high tibial osteotomy). 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 NCT04541342, which also lists 4 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 30 Jul 2024.