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Not yet recruitingNCT07907159Updated Oct 30, 2026

Hybrid Closed Wedge High Tibial Osteotomy

An interventional study of Hybrid Closed Wedge High Tibial Osteotomy in Patello-femoral Osteoarthritis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Updated Oct 30, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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 .

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Conditions studied

  • Patello-femoral Osteoarthritis

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Keywords

  • high tibial osteotomy
03

In context

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.

This study's planned enrollment of 20 is below the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Patients with medial knee compartment osteoarthritis with concomitant Anterior knee pain
  • Patients with Genu Varum deformity related to the tibia

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    HCWHTO arm

    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

    Procedure: Hybrid Closed Wedge High Tibial Osteotomy

Interventions

  • ProcedureHybrid Closed Wedge High Tibial Osteotomy

    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)

    Also known as: HCWHTO

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What researchers measure

Primary outcomes

  1. 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

    Time frame: from enrollment till 12 months post-operative

  2. 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)

    Time frame: from enrollment till 12 months post-operative

Secondary outcomes

  1. Mechanical axis correction

    The invistigators aim for HKA angle at approximately 0°

    Time frame: from enrollment till 12 months post-operative

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Study locations

No study locations are listed for this record.

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References and documents

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 20833833 ↗
  • Feucht 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 25008139 ↗
  • Duivenvoorden 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 26026274 ↗
  • Bito 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 20217394 ↗
  • Amis 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 22773067 ↗
  • Michael 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 ↗

Individual participant data

Plan to share: Undecided

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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2028, 23 months later.

Of 578 non-industry interventional studies with no phase under Osteoarthritis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 52. This study's planned 23 months is below that.

Counting every sponsor, half of 713 studies reached it within 29 months; a quarter within 11 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2026
First posted
Oct 30, 2026
StartEst.
Nov 15, 2026
Primary completionEst.
Nov 1, 2028
CompletionEst.
Feb 1, 2029
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07907159
Lead sponsor
Assiut University
Responsible party
Ahmed Mostafa Shafeek (Resident of Orthopedic and trauma surgery, Assiut University) — Principal investigator
First posted
Oct 30, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Nov 1, 2028 (estimated)
Completion
Feb 1, 2029 (estimated)
Last update
Oct 30, 2026

Study contacts

Ahmed Mostafa Shafeek
Contact
ahmedshafeekm@gmail.com
+201066169950

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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