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Knee OsteoarthritisNCT05807451

Anatomic Relationship Of the Popliteal Vessels In Open Wedge Osteotomy

An observational study of Knee Osteoarthritis, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Aim Is To Study The Anatomic Relationship Of The Popliteal Vesseles In Two Types Of (OWHTO) Techniques (Monoplanar VS Biplanar) Which Provide More Safe Technique To The PV Read more about this study

Who is it for?
Ages 30 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Knee Osteoarthritis
What is being tested?
High Tibial Osteotomy (Uniplanar and Biplanar )
Type of treatment
Surgery or procedure
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Sep 2022to 30 Aug 2024
Phase
Observational
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 30 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Patient Of Assuit univeristy hospital

Who may be able to join

  • age 30-60
  • BMI less than 40
  • isolated medial compartment OA
  • mild to moderate degree OA Grade 2 to 3 according to kellgren\&Lawrence classification
  • near normal lateral and patellofemoral compartment
  • intact lateral meniscus
  • varus malalignment less than 15 degree
  • functional range of motion

Who cannot join

  • inflammatory arthritis
  • post traumatic arthritis
  • patients with previous peripheral arterial injury
  • disease or prior insertion of metallic stent in the PV
  • patient allergic to contrast agent
  • patient with renal impairement
  • Patients who refuse to participate in the study
  • Patients who are not available for follow up

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut University

    Asyut, 71515

Other trials in Egypt

About this study

Official title: Anatomic Relationship Of the Popliteal Vessels In Two Types Of Open Wedge High Tibial Osteotomy ( Monoplanar VS Biplanar )

The Aim Is To Study The Anatomic Relationship Of The Popliteal Vesseles In Two Types Of (OWHTO) Techniques (Monoplanar VS Biplanar) Which Provide More Safe Technique To The PV

Read the detailed description

Open wedge High tibial osteotomy (OWHTO) is a common surgical Procedure that is utilized to correct knee varus deformity and prevent development or advancement of medial compatment knee osteoarthritis.

By turning the mechanical weight-bearing axis to the lateral side it correct lower limb alignment,decrease medial compartment load,pain,arthritic changes, postpone the need for arthroplasty and allow cartilage regeneration.

Like any other surgical procedure (OWHTO) has its own complications.injury to the popliteal vessels (PV) is catastrophic and limb threatening compliation that had been reported with prevalence rate ranging from 0.4% to 1.7% PV runs close to the posterior tibial cortex it might be injured while taking osteotomy cut. To avoid this problem many studies with different tools done to define PV position and its relations to provide safe technique for osteotomy.

(OWHTO) has different methods: Monoplanar and Biplanar osteotomy are most popular,both techniques differ in cut level and shape.

In this study the investigators compare between the two methods (Monoplanar VS Biplanar) concerning their proximity and safety to the PV .

Our hypothesis is that there is increase in the distance between the PV and the posterior tibial cortex the more distal the osteotomy level.

Previous studies cadaveric or preoperative studies provide useful informations with some different results , to the best of our knowledge postoperative studies rarely reported in this subject , the investigators hope this study could provide valuable informations,recommend safer technique and improve surgical outcomes from this procedure.

Being tested
High Tibial Osteotomy (Uniplanar and Biplanar )
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Tibial Osteotomy (Uniplanar and Biplanar )Procedure or surgery

    High Tibial Osteotomy using monoplanar and biplanar osteotomy techniques

Study groups in NCT05807451
Study groupRoleWhat they receive
Monoplanar Osteotomy groupHigh Tibial Osteotomy using single plane osteotomy
Receives: Procedure: High Tibial Osteotomy (Uniplanar and Biplanar )
Biplanar Osteotomy groupHigh Tibial Osteotomy using two plane osteotomy
Receives: Procedure: High Tibial Osteotomy (Uniplanar and Biplanar )

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. comparing between (OWHTO) methods Monoplanar and Biplanar which provide more safe technique to the PV.

    measuring distance (in mm) between Popliteal Vessels and Posterior Tibial Cortex at each osteotomy level using CT Angiography

    Measured: 3 months

Secondary outcomes (1)

  1. pain and function using Oxford Knee Score

    patient reports outcome questionnaire pre and post operative,measuring patient satisfaction,the score range from 0 to 48 (the higher the better the outcome)

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2023
  2. Study start1 Sep 2022
  3. Primary completion30 Aug 2023
  4. Study completion30 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05807451
Sponsor's protocol ID
Tibial Osteotomy
Status last verified
Feb 2026
First submitted
9 Aug 2022
Last updated
9 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Amendola A, Bonasia DE. Results of high tibial osteotomy: review of the literature. Int Orthop. 2010 Feb;34(2):155-60. doi: 10.1007/s00264-009-0889-8. Epub 2009 Oct 17.

    PubMed 19838706

  • Sabzevari S, Ebrahimpour A, Roudi MK, Kachooei AR. High Tibial Osteotomy: A Systematic Review and Current Concept. Arch Bone Jt Surg. 2016 Jun;4(3):204-12.

    PubMed 27517063

  • Kanamiya T, Naito M, Hara M, Yoshimura I. The influences of biomechanical factors on cartilage regeneration after high tibial osteotomy for knees with medial compartment osteoarthritis: clinical and arthroscopic observations. Arthroscopy. 2002 Sep;18(7):725-9. doi: 10.1053/jars.2002.35258.

    PubMed 12209429

  • Coventry MB. Upper tibial osteotomy. Clin Orthop Relat Res. 1984 Jan-Feb;(182):46-52.

    PubMed 6692627

  • Woodacre T, Ricketts M, Evans JT, Pavlou G, Schranz P, Hockings M, Toms A. Complications associated with opening wedge high tibial osteotomy--A review of the literature and of 15 years of experience. Knee. 2016 Mar;23(2):276-82. doi: 10.1016/j.knee.2015.09.018. Epub 2015 Nov 17.

    PubMed 26596554

  • Attinger MC, Behrend H, Jost B. Complete rupture of the popliteal artery complicating high tibial osteotomy. J Orthop. 2014 Oct 3;11(4):192-6. doi: 10.1016/j.jor.2014.08.002. eCollection 2014 Dec.

    PubMed 25561756

  • Chun KC, So BJ, Kang HT, Chun CH. Pseudoaneurysm Formation due to Popliteal Artery Injury Caused by Drilling during Medial Opening Wedge High Tibial Osteotomy. Knee Surg Relat Res. 2018 Dec 1;30(4):364-368. doi: 10.5792/ksrr.18.039.

    PubMed 30466257

  • Mori A, Matsushita T, Miyaji N, Nagai K, Araki D, Kanzaki N, Matsumoto T, Niikura T, Hoshino Y, Kuroda R. Analysis of popliteal artery location for high tibial and distal tuberosity osteotomy using contrast-enhanced computed tomography. Knee Surg Relat Res. 2022 May 8;34(1):25. doi: 10.1186/s43019-022-00154-2.

    PubMed 35527280

  • Kim J, Allaire R, Harner CD. Vascular safety during high tibial osteotomy: a cadaveric angiographic study. Am J Sports Med. 2010 Apr;38(4):810-5. doi: 10.1177/0363546510363664. Epub 2010 Mar 3.

    PubMed 20200321

  • Lee YS, Lee BK, Kim WS, Choi JS, Baek JR, Moon CW. Sagittal and coronal plane location of the popliteal artery in the open-wedge high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2014 Nov;22(11):2629-34. doi: 10.1007/s00167-013-2503-2. Epub 2013 Apr 17.

    PubMed 23592027

  • Kang T, Lee DW, Park JY, Han HS, Lee MC, Ro DH. Sawing toward the fibular head during open-wedge high tibial osteotomy carries the risk of popliteal artery injury. Knee Surg Sports Traumatol Arthrosc. 2020 May;28(5):1365-1371. doi: 10.1007/s00167-019-05439-w. Epub 2019 Feb 26.

    PubMed 30809721

  • Lobenhoffer P, Agneskirchner JD. Improvements in surgical technique of valgus high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2003 May;11(3):132-8. doi: 10.1007/s00167-002-0334-7. Epub 2003 Jan 11.

    PubMed 12774149

  • Choi CH, Lee WS, Jung M, Moon HS, Lee YH, Oh J, Kim SJ, Kim SH. Adequate protection rather than knee flexion prevents popliteal vascular injury during high tibial osteotomy: analysis of three-dimensional knee models in relation to knee flexion and osteotomy techniques. Knee Surg Sports Traumatol Arthrosc. 2020 May;28(5):1425-1435. doi: 10.1007/s00167-019-05515-1. Epub 2019 May 22.

    PubMed 31119339

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Osteoarthritis, run by Assiut University at 1 site 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 8 inclusion and 8 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 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

comparing between (OWHTO) methods Monoplanar and Biplanar which provide more safe technique to the PV. (time frame: 3 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 NCT05807451, which also lists 13 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 9 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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