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Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer

Primary Purpose

Muscle Injury, Nerve Injury, Poliomyelitis

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Interosseous route of TPTT
Extra membranous route of TPTT
Sponsored by
Iva Hauptmannova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Injury focused on measuring Foot drop deformity, gold standard treatment, Tibialis posterior tendon transfer, Interosseous route, Extramembranous or circumtibial route

Eligibility Criteria

16 Years - 85 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Traumatic peroneal nerve injuries in age group 16 yrs to 80 yrs Upper-level nerve injuries after hip and lumbar surgery

Exclusion Criteria:

  • Sciatic nerve injuries with tibial component Previous fractures to Distal 1/3rd Tibia and fibula Previous history of Neuropathy Patients who are mentally challenged, vulnerable or non- English speakers will not be part of our study.

Sites / Locations

  • Royal National Orthopaedic Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Interosseous route of TPTT

Extra membranous route of TPTT

Arm Description

The investigators will have two groups of patients, one who had their tendon transfer using the extra membranous route and other group which had their tendon transfer through the interosseous route. Patients will be randomized to either groups before the surgery and both the patients and the assessors will be blinded to the technique used. Both these techniques have been widely described in literature and are being extensively used in surgical management of foot drop. The selection of technique depends on surgeon choice and patient factors.

Extramembranous or circumtibial route of Tibialis Posterior tendon transfer.Both these techniques have been widely described in literature and are being extensively used in surgical management of foot drop. The selection of technique depends on surgeon choice and patient factors

Outcomes

Primary Outcome Measures

Change in Functional and clinical outcome at 6 and 12 months in these two groups using the Stanmore score.
The Stanmore score is unique, as being the only score to evaluate the results specific to tendon transfers for foot drop. Though this score is not validated but has been widely used as an outcome measure in various studies on tendon transfers. One of the secondary aims of the study will be to validate the Stanmore score.

Secondary Outcome Measures

Visual analogue scale foot and ankle (VAS FA) score
To compare VASFA, EQ-5D in the two groups of patients at 3, 6 and 12 months. We will also record the dynamic and static foot pressure measurements in these two groups of patients at 3, 6 and 12 months
EQ-5D
We will use EQ-5D as an index of quality of life and will compare it with normalized values for UK population
Validate the Stanmore score.
Validation of the Stanmore score. Data for the validation will be provided as part of another study, which aims to validate the score.

Full Information

First Posted
December 11, 2012
Last Updated
March 9, 2021
Sponsor
Iva Hauptmannova
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1. Study Identification

Unique Protocol Identification Number
NCT01751503
Brief Title
Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer
Official Title
Prospective Randomized Controlled Trial Comparing Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
investigator no longer available on site
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Iva Hauptmannova

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Foot drop deformity is a life limiting condition characterized by loss of ankle dorsiflexion and eversion. Main condition leading to drop foot condition include irrecoverable muscle and nerve injuries, poliomyelitis, drug poisoning, strokes, cerebral palsy, Charcot - Marie - Tooth disease, meningomyelocele, club foot, Friedreich's ataxia and Leprosy (1-4). Anterior transposition of Posterior tibialis tendon (PTT) is the gold standard for surgical restoration of functional dorsiflexion of a permanently paralyzed foot (1, 4-10). Two methods of rerouting the posterior tibialis tendon have been reported, one through the interosseous membrane i.e. Interosseous route (7, 10) and second subcutaneously around the medial side of tibia i.e. Extramembranous or circumtibial route (11-13). Both these techniques have been widely described in literature (4-16) and are being extensively used in surgical management of foot drop. The selection of technique depends on surgeon choice and patient factors. There is a clinical equipoise with regards to these two techniques of Tibialis posterior tendon transfer and through our study we aim to compare the clinical and functional outcomes of these two techniques. There are no studies in literature which compare the clinical and functional outcomes with regards to both these methods. Although there are many studies to demonstrate the functional and clinical effectiveness of the respective procedures, there is a paucity of clinical trials comparing these two surgical techniques with regards to clinical and functional outcomes. Furthermore there are no head to head clinical trials to compare the outcomes with regards to these two methods of Tibialis Posterior tendon transfer (Medline search dated 03/03/ 2012) we propose to compare the clinical and functional outcomes with regards to the two techniques i.e extra membranous and Interosseous technique of Tibialis Posterior tendon transfer performed in patients with foot drop as a result of nerve palsy. Through our prospective randomized trial we aim to answer the research question, whether one method has any superior outcome over the other?
Detailed Description
Foot drop deformity is a life limiting condition. This has far reaching consequences in patients of all age groups. Anterior transfer of tibialis posterior tendon is now regarded as the gold standard treatment as this allows walking without wearing an orthosis and thus substantial improvement in quality of life. This equally applies to developing and developed world. The rationale for our study is that that there is a clinical equipoise with regards to these two techniques of Tibialis posterior tendon transfer and through our study we aim to compare the clinical and functional outcomes of these two techniques. Both these techniques have been widely described in literature (References attached) and are being extensively used in surgical management of foot drop. The selection of technique depends on surgeon choice and patient factors. There are no studies in literature which compare the clinical and functional outcomes with regards to both these methods. Although there are many studies to demonstrate the functional and clinical effectiveness of the respective procedures, there is a paucity of clinical trials comparing these two surgical techniques with regards to clinical and functional outcomes. Furthermore there are no head to head clinical trials to compare the outcomes with regards to these two methods of Tibialis Posterior tendon transfer (Pub med search dated 12/03/2012) This study is of great interest to health care professionals managing foot drop both in developing and developed world. The answer to our research question; whether one surgical technique has better clinical, functional and quality of life over the other, will greatly impact the future surgical management of foot drop.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Injury, Nerve Injury, Poliomyelitis, Leprosy, Cerebral Palsy
Keywords
Foot drop deformity, gold standard treatment, Tibialis posterior tendon transfer, Interosseous route, Extramembranous or circumtibial route

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interosseous route of TPTT
Arm Type
Active Comparator
Arm Description
The investigators will have two groups of patients, one who had their tendon transfer using the extra membranous route and other group which had their tendon transfer through the interosseous route. Patients will be randomized to either groups before the surgery and both the patients and the assessors will be blinded to the technique used. Both these techniques have been widely described in literature and are being extensively used in surgical management of foot drop. The selection of technique depends on surgeon choice and patient factors.
Arm Title
Extra membranous route of TPTT
Arm Type
Active Comparator
Arm Description
Extramembranous or circumtibial route of Tibialis Posterior tendon transfer.Both these techniques have been widely described in literature and are being extensively used in surgical management of foot drop. The selection of technique depends on surgeon choice and patient factors
Intervention Type
Procedure
Intervention Name(s)
Interosseous route of TPTT
Intervention Description
Anterior transposition of Posterior tibialis tendon (PTT) is the gold standard for surgical restoration of functional dorsiflexion of a permanently paralyzed foot. Two methods of rerouting the posterior tibialis tendon have been reported, one through the interosseous membrane i.e. Interosseous route and second subcutaneously around the medial side of tibia i.e. Extramembranous or circumtibial route. Both these techniques have been widely described in literature and are being extensively used in surgical management of foot drop. The selection of technique depends on surgeon choice and patient factors
Intervention Type
Procedure
Intervention Name(s)
Extra membranous route of TPTT
Intervention Description
Rerouting the posterior tibialis tendon subcutaneously around the medial side of tibia i.e. Extramembranous or circumtibial route (
Primary Outcome Measure Information:
Title
Change in Functional and clinical outcome at 6 and 12 months in these two groups using the Stanmore score.
Description
The Stanmore score is unique, as being the only score to evaluate the results specific to tendon transfers for foot drop. Though this score is not validated but has been widely used as an outcome measure in various studies on tendon transfers. One of the secondary aims of the study will be to validate the Stanmore score.
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
Visual analogue scale foot and ankle (VAS FA) score
Description
To compare VASFA, EQ-5D in the two groups of patients at 3, 6 and 12 months. We will also record the dynamic and static foot pressure measurements in these two groups of patients at 3, 6 and 12 months
Time Frame
3,6 and 12 months
Title
EQ-5D
Description
We will use EQ-5D as an index of quality of life and will compare it with normalized values for UK population
Time Frame
3,6 and 12 Months
Title
Validate the Stanmore score.
Description
Validation of the Stanmore score. Data for the validation will be provided as part of another study, which aims to validate the score.
Time Frame
6 and 12 Months
Other Pre-specified Outcome Measures:
Title
Dynamic and static foot pressure measurement
Description
dynamic and static foot pressure measurement will be analysed using Foot pressure scanner. This is a one test, which determines the foot movement.
Time Frame
3,6 and 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Traumatic peroneal nerve injuries in age group 16 yrs to 80 yrs Upper-level nerve injuries after hip and lumbar surgery Exclusion Criteria: Sciatic nerve injuries with tibial component Previous fractures to Distal 1/3rd Tibia and fibula Previous history of Neuropathy Patients who are mentally challenged, vulnerable or non- English speakers will not be part of our study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Fox, FRCS (T&0)
Organizational Affiliation
Royal National Orthopaedic Hospital NHS Trust
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jagwant Singh, MBBS, MRCS
Organizational Affiliation
Royal National Orthopaedic Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal National Orthopaedic Hospital NHS Trust
City
London
State/Province
Middlesex
ZIP/Postal Code
HA7 4LP
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.rnoh.nhs.uk/
Description
Trust web site

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Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer

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