Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer

This study is currently recruiting participants.

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Contacts and Locations

Verified May 2017 by Iva Hauptmannova, Royal National Orthopaedic Hospital NHS Trust

Sponsor:

ClinicalTrials.gov Identifier:

NCT01751503

First Posted: December 18, 2012

Last Update Posted: May 22, 2017

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Information provided by (Responsible Party):

Iva Hauptmannova, Royal National Orthopaedic Hospital NHS Trust

Purpose

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?

Condition	Intervention
Muscle Injury Nerve Injury Poliomyelitis Leprosy Cerebral Palsy	Procedure: Interosseous route of TPTT Procedure: Extra membranous route of TPTT


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Prospective Randomized Controlled Trial Comparing Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer.

Resource links provided by NLM:

MedlinePlus related topics: Foot Health

Genetic and Rare Diseases Information Center resources: Cerebral Palsy Hansen's Disease Poliomyelitis Myelitis

U.S. FDA Resources

Further study details as provided by Iva Hauptmannova, Royal National Orthopaedic Hospital NHS Trust:

Primary Outcome Measures:

Change in Functional and clinical outcome at 6 and 12 months in these two groups using the Stanmore score. [ Time Frame: 6 and 12 months ]
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 [ Time Frame: 3,6 and 12 months ]
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 [ Time Frame: 3,6 and 12 Months ]
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. [ Time Frame: 6 and 12 Months ]
Validation of the Stanmore score. Data for the validation will be provided as part of another study, which aims to validate the score.

Other Outcome Measures:

Dynamic and static foot pressure measurement [ Time Frame: 3,6 and 12 Months ]
dynamic and static foot pressure measurement will be analysed using Foot pressure scanner. This is a one test, which determines the foot movement.


Estimated Enrollment:	52
Study Start Date:	March 2013
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Interosseous route of TPTT 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.	Procedure: Interosseous route of TPTT 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
Active Comparator: Extra membranous route of TPTT 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	Procedure: Extra membranous route of TPTT Rerouting the posterior tibialis tendon subcutaneously around the medial side of tibia i.e. Extramembranous or circumtibial route (

Arms

Assigned Interventions

Active Comparator: Interosseous route of TPTT

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.

Procedure: Interosseous route of TPTT

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

Active Comparator: Extra membranous route of TPTT

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

Procedure: Extra membranous route of TPTT

Rerouting the posterior tibialis tendon subcutaneously around the medial side of tibia i.e. Extramembranous or circumtibial route (

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	16 Years to 85 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751503

Contacts


Contact: Iva Hauptmannova, BSC, MA	0044(0)2086065529	research@rnoh.nhs.uk
Contact: Jagwant Singh, MBBS, MRCS	00447912862591	drjagwant@gmail.com

Locations


United Kingdom
Royal National Orthopaedic Hospital NHS Trust	Recruiting
London, Middlesex, United Kingdom, HA7 4LP
Contact: Iva Hauptmannova, BSc,MA 0044(0)2086065529 research@rnoh.nhs.uk
Sub-Investigator: Marco Sinisi, MD
Sub-Investigator: Anthony MacQuillan, FRCS
Principal Investigator: Jagwant Singh, MBBS,MRCS

Sponsors and Collaborators

Iva Hauptmannova

Investigators


Study Director:	Michael Fox, FRCS (T&0)	Royal National Orthopaedic Hospital NHS Trust
Principal Investigator:	Jagwant Singh, MBBS, MRCS	Royal National Orthopaedic Hospital NHS Trust

More Information

Additional Information:

Trust web site This link exits the ClinicalTrials.gov site


Responsible Party:	Iva Hauptmannova, Research & Development Manager, Royal National Orthopaedic Hospital NHS Trust
ClinicalTrials.gov Identifier:	NCT01751503 History of Changes
Other Study ID Numbers:	RCT- PTTT RNOH- PNI- RCT-PTTT ( Other Identifier: RNOH- PNI )
First Submitted:	December 11, 2012
First Posted:	December 18, 2012
Last Update Posted:	May 22, 2017
Last Verified:	May 2017

Keywords provided by Iva Hauptmannova, Royal National Orthopaedic Hospital NHS Trust:


Foot drop deformity gold standard treatment Tibialis posterior tendon transfer Interosseous route Extramembranous or circumtibial route

Additional relevant MeSH terms:


Wounds and Injuries Cerebral Palsy Poliomyelitis Leprosy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Enterovirus Infections Picornaviridae Infections	RNA Virus Infections Virus Diseases Myelitis Central Nervous System Infections Spinal Cord Diseases Neuromuscular Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections

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