Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer

NCT01751503 | Terminated

• 2 other identifiers: RCT- PTTTRNOH- PNI- RCT-PTTT
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 and 12 months

Secondary Outcomes (3)

• Visual analogue scale foot and ankle (VAS FA) score

  3,6 and 12 months

• EQ-5D

  3,6 and 12 Months

• Validate the Stanmore score.

  6 and 12 Months

Other Outcomes (1)

• Dynamic and static foot pressure measurement

  3,6 and 12 Months

Study Arms (2)

Interosseous route of TPTT

ACTIVE COMPARATOR

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

Extra membranous route of TPTT

ACTIVE COMPARATOR

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

Interventions

Interosseous route of TPTT PROCEDURE

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

Interosseous route of TPTT

Extra membranous route of TPTT PROCEDURE

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

Extra membranous route of TPTT

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iva Hauptmannova: lead

Study Sites (1)

Royal National Orthopaedic Hospital NHS Trust

London, Middlesex, HA7 4LP, United Kingdom

Location

Related Links

• Trust web site

MeSH Terms

Conditions

Poliomyelitis; Leprosy; Cerebral Palsy

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Brain Damage, Chronic; Brain Diseases

Study Officials

• Michael Fox, FRCS (T&0)

  Royal National Orthopaedic Hospital NHS Trust

  STUDY DIRECTOR

• Jagwant Singh, MBBS, MRCS

  Royal National Orthopaedic Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research & Development Manager

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: December 18, 2012
• Study Start: March 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 10, 2021

Record last verified: 2021-03

Locations

GB (1)