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Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Royal National Orthopaedic Hospital NHS Trust
Sponsor:
Information provided by (Responsible Party):
Iva Hauptmannova, Royal National Orthopaedic Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT01751503
First received: December 11, 2012
Last updated: November 3, 2014
Last verified: November 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: July 2017
Estimated Primary Completion Date: July 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 (

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

Ages Eligible for Study:   16 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: December 11, 2012
Last Updated: November 3, 2014
Health Authority: United Kingdom: Department of Health

Keywords provided by 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:
Poliomyelitis
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Enterovirus Infections
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014