Patello-femoral OsteoarthritisNCT07907159
Hybrid Closed Wedge High Tibial Osteotomy
A study testing Hybrid Closed Wedge High Tibial Osteotomy in people with Patello-femoral Osteoarthritis, run by Assiut University.
Trial summary
Osteoarthritis (OA) is the most prevalent condition of the knee joint. High tibial osteotomy (HTO) is an effective treatment for medial compartmental osteoarthritis (OA) of the knee with good clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Patello-femoral Osteoarthritis
- What is being tested?
- Hybrid Closed Wedge High Tibial Osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 1 Feb 2029
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with medial knee compartment osteoarthritis with concomitant Anterior knee pain
- Patients with Genu Varum deformity related to the tibia
Who cannot join
- Inflammatory arthritis
- Advanced tricompartmental osteoarthritis or severe lateral compartment osteoarthritis.
- Knee flexion contracture >15°.
- Limited knee range of motion (e.g., flexion <90°).
- Significant peripheral vascular disease.
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: Short Term Results of Hybrid Closed Wedge High Tibial Osteotomy: A Case Series
Osteoarthritis (OA) is the most prevalent condition of the knee joint. High tibial osteotomy (HTO) is an effective treatment for medial compartmental osteoarthritis (OA) of the knee with good clinical outcomes. In particular, the two most commonly used surgical techniques of HTO are medial open wedge HTO (OWHTO) and lateral closed wedge HTO (CWHTO). However, OWHTO has been reported to have a negative effect on the patellofemoral (PF) joint postoperatively due to a decrease in patellar height and an increase in PF contact pressure, in contrast to CWHTO. Biomechanical studies indicated that the alteration in patellar height can be attributed to distalization of the tibial tuberosity following OWHTO, which leads to the patella being pulled down toward the joint lines. In CWHTO, the tibial tuberosity was reported to move proximally in a biomechanical study. Therefore, CWHTO may lead to improvement of PF joint congruity compared with descending OWHTO. Meanwhile, CWHTO has also been reported to have several disadvantages, such as loss of the large bone block below the lateral tibial plateau, increase in lateral offset due to the horizontal osteotomy, and late full weight-bearing walking. To improve these disadvantages, the hybrid closed wedge HTO (HCWHTO) technique, a kind of CWHTO, was developed. The points of difference for HCWHTO compared with conventional CWHTO are an oblique osteotomy to achieve a large contact area, a contact for the lateral cortices in the proximal and distal fragments without lateral offset for early full weight-bearing, and a removal of a smaller bone wedge to maintain leg length. Furthermore, this procedure has good effects on PF joint congruity through improvement in tibial tuberosity-trochlear groove distance and the proximalization of the tibial tuberosity when compared with OWHTO If a patient has PF-OA preoperatively, HCWHTO may be chosen to prevent progression of PF-OA postoperatively. However, HCWHTO may be performed in patients with varus deformity of the knee combined with PF-OA, because progression of PF-OA is correlated with varus knee .
- Conditions
- Patello-femoral Osteoarthritis
- Being tested
- Hybrid Closed Wedge High Tibial Osteotomy
- Keywords
- high tibial osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Closed Wedge High Tibial OsteotomyProcedure or surgery
Also called HCWHTO
Under knee arthroscopy, lateral retinacular release (LRR) of the PF joint will be performed.
Before the tibial osteotomy, the fibular osteotomy at the mid-portion and segmental resection will be performed.
The tibia will undergo biplanar osteotomy. The hinge point that divides the proximal tibial osteotomy line by approximately 2-1 will be then determined.
After removal of the lateral closed wedge bone block, the medial side will be opened, and the lateral side will be closed.
A lateral tibial haed plate will be inserted on the lateral side of the tibia after plate bending for the proximal screws to become parallel to the tibial plateau and will be fixed in place with locking screws with.
- Osteotomy opening angle and correction will be achieved intraoperatively.
- Type of fixation device will be used (plate/screws)
| Study group | Role | What they receive |
|---|---|---|
| HCWHTO arm | Experimental | Patients with medial knee compartment osteoarthritis and genu varum deformity who undergo Hybrid Closed Wedge High Tibial Osteotomy (HCWHTO) with arthroscopic lateral retinacular release, followed by clinical and radiological follow-up at 6 weeks, 6 months, and 12 months postoperatively Receives: Procedure: Hybrid Closed Wedge High Tibial Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement by KOOS Functional knee score
Validated knee scoring systems will be recorded preoperatively and during follow-up by Knee injury and Osteoarthritis Outcome Score (KOOS)
The standard full-length KOOS consists of 42 items divided into 5 separate subscales:
- Pain (9 items)
- Other Symptoms (such as swelling, stiffness, and range of motion) (7 items)
- Function in Daily Living (ADL) (17 items)
- Function in Sport and Recreation (Sport/Rec) (5 items)
- Knee-Related Quality of Life (QOL) (4 items
Scoring
- Format: Patients rate each item using a 5-point Likert scale (from 0 to 4) based on their experiences over the preceding week.
- Scale: Each subscale is calculated independently and transformed to a 0 to 100 scale.
- Interpretation:
- 0 represents extreme knee problems / total disability.
- 100 represents no knee problems / perfect joint health.
- No Total Score: An aggregate or single total score is not calculated
Measured: from enrollment till 12 months post-operative
Clinical improvement by AKPS Functional knee score
Validated knee scoring systems will be recorded preoperatively and during follow-up by Kujala Anterior Knee Pain Scale (AKPS) The AKPS is a 13-item, patient-reported questionnaire used to evaluate subjective symptoms and functional limitations in people with patellofemoral disorders Overview of the Scale
- Total Score Range: 0 to 100 points
- Interpretation:
- 85-100: Near-normal / minimal dysfunction (Excellent)
- 70-84: Mild dysfunction (Scores around 70 often reflect moderate disability)
- 50-69: Moderate patellofemoral dysfunction (Fair)
- 0-49: Severe patellofemoral dysfunction with significant pain and limitations (Poor)
Measured: from enrollment till 12 months post-operative
Secondary outcomes (1)
Mechanical axis correction
The invistigators aim for HKA angle at approximately 0°
Measured: from enrollment till 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Patello-femoral 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mostafa Shafeek, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907159
- Sponsor's protocol ID
- Resultsofhightibialosteotomy
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hui C, Salmon LJ, Kok A, Williams HA, Hockers N, van der Tempel WM, Chana R, Pinczewski LA. Long-term survival of high tibial osteotomy for medial compartment osteoarthritis of the knee. Am J Sports Med. 2011 Jan;39(1):64-70. doi: 10.1177/0363546510377445. Epub 2010 Sep 10.
PubMed 20833833Feucht MJ, Minzlaff P, Saier T, Cotic M, Sudkamp NP, Niemeyer P, Imhoff AB, Hinterwimmer S. Degree of axis correction in valgus high tibial osteotomy: proposal of an individualised approach. Int Orthop. 2014 Nov;38(11):2273-80. doi: 10.1007/s00264-014-2442-7. Epub 2014 Jul 10.
PubMed 25008139Duivenvoorden T, van Diggele P, Reijman M, Bos PK, van Egmond J, Bierma-Zeinstra SMA, Verhaar JAN. Adverse events and survival after closing- and opening-wedge high tibial osteotomy: a comparative study of 412 patients. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):895-901. doi: 10.1007/s00167-015-3644-2. Epub 2015 May 31.
PubMed 26026274Bito H, Takeuchi R, Kumagai K, Aratake M, Saito I, Hayashi R, Sasaki Y, Saito T. Opening wedge high tibial osteotomy affects both the lateral patellar tilt and patellar height. Knee Surg Sports Traumatol Arthrosc. 2010 Jul;18(7):955-60. doi: 10.1007/s00167-010-1077-5. Epub 2010 Mar 9.
PubMed 20217394Amis AA. Biomechanics of high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2013 Jan;21(1):197-205. doi: 10.1007/s00167-012-2122-3. Epub 2012 Jul 7.
PubMed 22773067Michael JW, Schluter-Brust KU, Eysel P. The epidemiology, etiology, diagnosis, and treatment of osteoarthritis of the knee. Dtsch Arztebl Int. 2010 Mar;107(9):152-62. doi: 10.3238/arztebl.2010.0152. Epub 2010 Mar 5.
PubMed 20305774
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Results of Hybrid Closed Wedge High Tibial Osteotomy: A Case Series
- ClinicalTrials.gov ID
- NCT07907159
- Acronym / sponsor ID
- Resultsofhightibialosteotomy
- Conditions
- Patello-femoral Osteoarthritis
- Keywords
- high tibial osteotomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 30 Oct 2026 (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 (OA) is the most prevalent condition of the knee joint. High tibial osteotomy (HTO) is an effective treatment for medial compartmental osteoarthritis (OA) of the knee with good clinical outcomes. In particular, the two most commonly used surgical techniques of HTO are medial open wedge HTO (OWHTO) and lateral closed wedge HTO (CWHTO). However, OWHTO has been reported to have a negative effect on the patellofemoral (PF) joint postoperatively due to a decrease in patellar height and an increase in PF contact pressure, in contrast to CWHTO. Biomechanical studies indicated that the alteration in patellar height can be attributed to distalization of the tibial tuberosity following OWHTO, which leads to the patella being pulled down toward the joint lines. In CWHTO, the tibial tuberosity was reported to move proximally in a biomechanical study. Therefore, CWHTO may lead to improvement of PF joint congruity compared with descending OWHTO. Meanwhile, CWHTO has also been reported to have several disadvantages, such as loss of the large bone block below the lateral tibial plateau, increase in lateral offset due to the horizontal osteotomy, and late full weight-bearing walking. To improve these disadvantages, the hybrid closed wedge HTO (HCWHTO) technique, a kind of CWHTO, was developed. The points of difference for HCWHTO compared with conventional CWHTO are an oblique osteotomy to achieve a large contact area, a contact for the lateral cortices in the proximal and distal fragments without lateral offset for early full weight-bearing, and a removal of a smaller bone wedge to maintain leg length. Furthermore, this procedure has good effects on PF joint congruity through improvement in tibial tuberosity-trochlear groove distance and the proximalization of the tibial tuberosity when compared with OWHTO If a patient has PF-OA preoperatively, HCWHTO may be chosen to prevent progression of PF-OA postoperatively. However, HCWHTO may be performed in patients with varus deformity of the knee combined with PF-OA, because progression of PF-OA is correlated with varus knee .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCWHTO arm | Experimental | Procedure: Hybrid Closed Wedge High Tibial OsteotomyPatients with medial knee compartment osteoarthritis and genu varum deformity who undergo Hybrid Closed Wedge High Tibial Osteotomy (HCWHTO) with arthroscopic lateral retinacular release, followed by clinical and radiological follow-up at 6 weeks, 6 months, and 12 months postoperatively |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with medial knee compartment osteoarthritis with concomitant Anterior knee pain
- Patients with Genu Varum deformity related to the tibia
Key exclusion criteria (5 listed)
- Inflammatory arthritis
- Advanced tricompartmental osteoarthritis or severe lateral compartment osteoarthritis.
- Knee flexion contracture >15°.
- Limited knee range of motion (e.g., flexion <90°).
- Significant peripheral vascular disease.
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 |
|---|---|---|
| Hybrid Closed Wedge High Tibial OsteotomyAlso: HCWHTOUnder knee arthroscopy, lateral retinacular release (LRR) of the PF joint will be performed. Before the tibial osteotomy, the fibular osteotomy at the mid-portion and segmental resection will be performed. The tibia will undergo biplanar osteotomy. The hinge point that divides the proximal tibial osteotomy line by approximately 2-1 will be then determined. After removal of the lateral closed wedge bone block, the medial side will be opened, and the lateral side will be closed. A lateral tibial haed plate will be inserted on the lateral side of the tibia after plate bending for the proximal screws to become parallel to the tibial plateau and will be fixed in place with locking screws with. * Osteotomy opening angle and correction will be achieved intraoperatively. * Type of fixation device will be used (plate/screws) | Procedure or surgery | HCWHTO arm |
Primary outcome
Clinical improvement by KOOS Functional knee score
Time frame: from enrollment till 12 months post-operative
Validated knee scoring systems will be recorded preoperatively and during follow-up by Knee injury and Osteoarthritis Outcome Score (KOOS) The standard full-length KOOS consists of 42 items divided into 5 separate subscales: * Pain (9 items) * Other Symptoms (such as swelling, stiffness, and range of motion) (7 items) * Function in Daily Living (ADL) (17 items) * Function in Sport and Recreation (Sport/Rec) (5 items) * Knee-Related Quality of Life (QOL) (4 items Scoring * Format: Patients rate each item using a 5-point Likert scale (from 0 to 4) based on their experiences over the preceding week. * Scale: Each subscale is calculated independently and transformed to a 0 to 100 scale. * Interpretation: * 0 represents extreme knee problems / total disability. * 100 represents no knee problems / perfect joint health. * No Total Score: An aggregate or single total score is not calculated
Clinical improvement by AKPS Functional knee score
Time frame: from enrollment till 12 months post-operative
Validated knee scoring systems will be recorded preoperatively and during follow-up by Kujala Anterior Knee Pain Scale (AKPS) The AKPS is a 13-item, patient-reported questionnaire used to evaluate subjective symptoms and functional limitations in people with patellofemoral disorders Overview of the Scale * Total Score Range: 0 to 100 points * Interpretation: * 85-100: Near-normal / minimal dysfunction (Excellent) * 70-84: Mild dysfunction (Scores around 70 often reflect moderate disability) * 50-69: Moderate patellofemoral dysfunction (Fair) * 0-49: Severe patellofemoral dysfunction with significant pain and limitations (Poor)
1 secondary outcome
Mechanical axis correction
Time frame: from enrollment till 12 months post-operative
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 30 Oct 2026.
- Background: PubMed 20833833Hui C, Salmon LJ, Kok A, Williams HA, Hockers N, van der Tempel WM, Chana R, Pinczewski LA. Long-term survival of high tibial osteotomy for medial compartment osteoarthritis of the knee. Am J Sports Med. 2011 Jan;39(1):64-70. doi: 10.1177/0363546510377445. Epub 2010 Sep 10.
- Background: PubMed 25008139Feucht MJ, Minzlaff P, Saier T, Cotic M, Sudkamp NP, Niemeyer P, Imhoff AB, Hinterwimmer S. Degree of axis correction in valgus high tibial osteotomy: proposal of an individualised approach. Int Orthop. 2014 Nov;38(11):2273-80. doi: 10.1007/s00264-014-2442-7. Epub 2014 Jul 10.
- Background: PubMed 26026274Duivenvoorden T, van Diggele P, Reijman M, Bos PK, van Egmond J, Bierma-Zeinstra SMA, Verhaar JAN. Adverse events and survival after closing- and opening-wedge high tibial osteotomy: a comparative study of 412 patients. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):895-901. doi: 10.1007/s00167-015-3644-2. Epub 2015 May 31.
- Background: PubMed 20217394Bito H, Takeuchi R, Kumagai K, Aratake M, Saito I, Hayashi R, Sasaki Y, Saito T. Opening wedge high tibial osteotomy affects both the lateral patellar tilt and patellar height. Knee Surg Sports Traumatol Arthrosc. 2010 Jul;18(7):955-60. doi: 10.1007/s00167-010-1077-5. Epub 2010 Mar 9.
- Background: PubMed 22773067Amis AA. Biomechanics of high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2013 Jan;21(1):197-205. doi: 10.1007/s00167-012-2122-3. Epub 2012 Jul 7.
- Background: PubMed 20305774Michael JW, Schluter-Brust KU, Eysel P. The epidemiology, etiology, diagnosis, and treatment of osteoarthritis of the knee. Dtsch Arztebl Int. 2010 Mar;107(9):152-62. doi: 10.3238/arztebl.2010.0152. Epub 2010 Mar 5.
- Individual participant dataSharing planned: Undecided
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 Hybrid Closed Wedge High Tibial Osteotomy in people with Patello-femoral 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 2 inclusion and 5 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 30 Oct 2026. 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 Ahmed Mostafa Shafeek (+201066169950, ahmedshafeekm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement by KOOS Functional knee score (time frame: from enrollment till 12 months post-operative). The study lists 2 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 NCT07907159, which also lists 6 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 Oct 2026.