NCT03443648

Brief Summary

Assessment of accuracy of correction of genu varum more than 20 degrees using external fixator assisted plating. Intraoperatively, the operative time needed for completion of accurate correction, torniquet use, blood loss will be assessed. Postoperative complications either early ones like infection, thromboembolic complications, peroneal nerve palsy or late post operative complications like implant failure, delayed union, non union and bone healing time will be assessed..

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

November 25, 2017

Last Update Submit

April 28, 2018

Conditions

Deformity

Outcome Measures

Primary Outcomes (1)

  • assesment of accuracy of correction of high degree genu varum using this method of correction.

    assessment of mechanical axis deviation in degrees, mechanical tibiofemral angle in degrees, medial proximal tibial angle in degrees and the position of mechanical axis ratio. They are all measured in the immediate post operative long film and the long film after one year. The normal angles are known documented angles so, we will compare the preoperative and postoperative angles with the normal ones.Immediate postoperative long film on the lower limbs to compare pre and postoperative angles with the normal angles. Another long film is done after one year to follow up the achieved correction

    one year

Interventions

External fixator assisted plaingPROCEDURE

The plate length is marked on the skin. Limb reconstruction system (LRS) with one swivel clamp or Taylor Spatial frame (TSF) is used in all cases. The fixator is put in a plane parallel to that of the deformity. Two tapered pins are placed on either side of the planned osteotomy site and passed at a distance from the osteotomy so that they will not impede the subsequent internal fixation. Swivel clamps or the struts of the TSF are aligned in such a way that full correction is achieved. After osteotomy, swivel clamp is loosened and angular correction is achieved. Translation is carried out according to preoperative planning. If readjustment is required the swivel clamps or TSF struts are loosened and further correction is carried out. Once desired correction is achieved, the clamps or struts are tightened. Definitive internal fixation is carried out while external fixation holds the fragments. For internal fixation, locked T plate will be used.

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18years old or more
  • Varus 20 degrees or more

You may not qualify if:

  • Contraindication to internal fixation
  • Associated osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • Hochberg MC, Altman RD, Brandt KD, Clark BM, Dieppe PA, Griffin MR, Moskowitz RW, Schnitzer TJ. Guidelines for the medical management of osteoarthritis. Part II. Osteoarthritis of the knee. American College of Rheumatology. Arthritis Rheum. 1995 Nov;38(11):1541-6. doi: 10.1002/art.1780381104.

    PMID: 7488273BACKGROUND

  • Sharma L, Song J, Felson DT, Cahue S, Shamiyeh E, Dunlop DD. The role of knee alignment in disease progression and functional decline in knee osteoarthritis. JAMA. 2001 Jul 11;286(2):188-95. doi: 10.1001/jama.286.2.188.

    PMID: 11448282BACKGROUND

  • Hernigou P, Medevielle D, Debeyre J, Goutallier D. Proximal tibial osteotomy for osteoarthritis with varus deformity. A ten to thirteen-year follow-up study. J Bone Joint Surg Am. 1987 Mar;69(3):332-54.

    PMID: 3818700BACKGROUND

  • Tuli SM, Kapoor V. High tibial closing wedge osteotomy for medial compartment osteoarthrosis of knee. Indian J Orthop. 2008 Jan;42(1):73-7. doi: 10.4103/0019-5413.38585.

    PMID: 19823659BACKGROUND

  • Sundaram NA, Hallett JP, Sullivan MF. Dome osteotomy of the tibia for osteoarthritis of the knee. J Bone Joint Surg Br. 1986 Nov;68(5):782-6. doi: 10.1302/0301-620X.68B5.3782246.

    PMID: 3782246BACKGROUND

  • Rozbruch SR, Segal K, Ilizarov S, Fragomen AT, Ilizarov G. Does the Taylor Spatial Frame accurately correct tibial deformities? Clin Orthop Relat Res. 2010 May;468(5):1352-61. doi: 10.1007/s11999-009-1161-7. Epub 2009 Nov 13.

    PMID: 19911244BACKGROUND

  • Kazemi SM, Qoreishi M, Behboudi E, Manafi A, Kazemi SK. Evaluation of Changes in the Tibiotalar joint after High Tibial Osteotomy. Arch Bone Jt Surg. 2017 May;5(3):149-152.

    PMID: 28656162BACKGROUND

  • Gugenheim JJ Jr, Brinker MR. Bone realignment with use of temporary external fixation for distal femoral valgus and varus deformities. J Bone Joint Surg Am. 2003 Jul;85(7):1229-37. doi: 10.2106/00004623-200307000-00008.

    PMID: 12851347BACKGROUND

  • Bar-On E, Becker T, Katz K, Velkes S, Salai M, Weigl DM. Corrective lower limb osteotomies in children using temporary external fixation and percutaneous locking plates. J Child Orthop. 2009 Apr;3(2):137-43. doi: 10.1007/s11832-009-0165-x. Epub 2009 Mar 12.

    PMID: 19308625BACKGROUND

  • Rozbruch SR. Fixator-assisted plating of limb deformities. Oper Tech Orthop. 2011;21:174-.

    BACKGROUND

  • Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.

    PMID: 2805470BACKGROUND

  • Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.

    PMID: 4028566BACKGROUND

  • Paley D, Herzenberg JE, Tetsworth K, McKie J, Bhave A. Deformity planning for frontal and sagittal plane corrective osteotomies. Orthop Clin North Am. 1994 Jul;25(3):425-65.

    PMID: 8028886BACKGROUND

  • Paley D. 1st ed. New York: Springer; 2002. Principles of deformity correction; p 1-18.12.

    BACKGROUND

  • Paley D. 1st ed. New York: Springer; 2002. Principles of deformity correction; pp. 175-94

    BACKGROUND

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Kerolos Maged, MBBCH

CONTACT

+2/01063692926Kerolosmaged230@gmail.com

Wael El Adly, MD

CONTACT

01224265850eladlyw@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in the orhtopaedics and traumatology department

Study Record Dates

First Submitted

November 25, 2017

First Posted

February 23, 2018

Study Start

June 1, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

May 1, 2018

Record last verified: 2018-04