Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer
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| First Received Date ICMJE | December 11, 2012 | ||||||||
| Last Updated Date | December 17, 2012 | ||||||||
| Start Date ICMJE | March 2013 | ||||||||
| Estimated Primary Completion Date | July 2017 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01751503 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE |
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. |
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| Original Other Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer | ||||||||
| Official Title ICMJE | Prospective Randomized Controlled Trial Comparing Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer. | ||||||||
| 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? |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 52 | ||||||||
| Estimated Completion Date | July 2017 | ||||||||
| Estimated Primary Completion Date | July 2017 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 16 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01751503 | ||||||||
| Other Study ID Numbers ICMJE | RCT- PTTT, RNOH- PNI- RCT-PTTT | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Iva Hauptmannova, Royal National Orthopaedic Hospital NHS Trust | ||||||||
| Study Sponsor ICMJE | Iva Hauptmannova | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Royal National Orthopaedic Hospital NHS Trust | ||||||||
| Verification Date | December 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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