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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

December 11, 2012
November 3, 2014
March 2013
July 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01751503 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
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.
Same as current
 
Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer
Prospective Randomized Controlled Trial Comparing Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer.

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?

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Muscle Injury
  • Nerve Injury
  • Poliomyelitis
  • Leprosy
  • Cerebral Palsy
  • 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
  • Procedure: Extra membranous route of TPTT
    Rerouting the posterior tibialis tendon subcutaneously around the medial side of tibia i.e. Extramembranous or circumtibial route (
  • 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.
    Intervention: Procedure: Interosseous route of TPTT
  • 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
    Intervention: Procedure: Extra membranous route of TPTT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
52
July 2017
July 2017   (final data collection date for primary outcome measure)

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.
Both
16 Years to 85 Years
Yes
Contact: Iva Hauptmannova, BSC, MA 0044(0)2086065529 research@rnoh.nhs.uk
Contact: Jagwant Singh, MBBS, MRCS 00447912862591 drjagwant@gmail.com
United Kingdom
 
NCT01751503
RCT- PTTT, RNOH- PNI- RCT-PTTT
No
Iva Hauptmannova, Royal National Orthopaedic Hospital NHS Trust
Iva Hauptmannova
Not Provided
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
Royal National Orthopaedic Hospital NHS Trust
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP