Clinical studies

This is a selection of articles related to our product areas.

Full copies of the journal articles can be obtained by contacting a library or the appropriate journal. Reprints of some of the articles may be available from Atos Medical and information can be obtained by contacting our Clinical Affairs Department.

Laryngology articles

Provox® Voice Prostheses

• Ward EC, Hancock K, Lawson N, van As-Brooks CJ. Perceptual characteristics of speech production using the new indwelling Provox Vega voice prosthesis: A randomized controlled cross-over trial. Head & Neck. In press 2010.
• Hancock K, Ward EC, Lawson N, van As-Brooks CJ. A RCT of two indwelling voice prostheses: Patient preferences. 2009 Nov 20; New Orleans, LA, USA: ASHA; 2009.
• Hilgers FJ, Ackerstaff AH, Jacobi I, Balm AJ, Tan B, Van den Brekel MW. Prospective clinical phase II study of two new indwelling voice prostheses (Provox Vega 22.5 and 20 Fr) and a novel anterograde insertion device (Provox SmartInserter). Laryngoscope. In press 2010.
• Hilgers FJ, Ackerstaff AH, van RM et al. Clinical phase I/feasibility study of the next generation indwelling Provox voice prosthesis (Provox Vega). Acta Otolaryngologica 2010 April; 130(4):511- 9..
• Bozec A, Poissonnet G, Chamorey E, Demard F, Santini J, Peyrade F, Ortholan C, Benezery K, Thariat J, Sudaka A, Anselme K, Adrey B, Giacchero P, Dassonville O. Results of vocal rehabilitation using tracheoesophageal voice prosthesis after total laryngectomy and their predictive factors. European Archives of Otorhinolaryngology 2010 May;267(5):751-8.
• Boscolo-Rizzo P, Marchiori C, Gava A, Da Mosto MC. The impact of radiotherapy and GERD on in situ lifetime of indwelling voice prostheses. European Archives of Otorhinolaryngology 2008 July; 265(7): 791-6.
• Lam PK, Ho WK, Ho AC, Ng RW, Yuen AP, Wei WI. Long-term performance of indwelling tracheoesophageal speaking valves in Chinese patients undergoing laryngectomy. Archives of Otolaryngology- Head and Neck Surgery 2005 November;131(11):954-8.
• Kummer P, Chahoud M, Schuster M, Eysholdt U, Rosanowski F. [Prosthetic voice rehabilitation after laryngectomy : Failures and complications after previous radiation therapy.]. HNO 2006 April;54(4):315-22
• Bien S, Okla S. [Analysis of complications after surgical voice and speech rehabilitation in laryngectomized patients. Problems related to implantation and change of voice prosthesis]. Otolaryngologica Polska 2006;60(2):129-34.
• Terada T, Saeki N, Toh K et al. Voice rehabilitation with Provox2 voice prosthesis following total laryngectomy for laryngeal and hypopharyngeal carcinoma. Auris Nasus Larynx 2007 March;34(1):65-71.
• Boscolo-Rizzo P, Zanetti F, Carpené S, Da Mosto MC. Long-term results with tracheoesophageal voice prosthesis: Primary versus secondary TEP. European Archives of Otorhinolaryngology 2008 Jan; 265(1): 73-77.
• Padhya TA, Athavale SM, Morgan JM, McCaffrey TV. An alternative approach for secondary tracheoesophageal puncture in the difficult laryngectomy neck. The Laryngoscope 2008 Feb; 118(2): 266-269.
• Soolsma J, Van Den Brekel MW, Ackerstaff AH, Malm AJ, Tan B, Hilgers FJ. Long-term results of Provox ActiValve, solving the problem of frequent Candida- and “Underpressure”-related voice prosthesis replacements. The Laryngoscope 2008 Feb; 118(2): 252-257.
• Ramalingam WVBS, Chikara D, Rajagopal G, Mehta AR, Sarkar S. Tracheo-esophageal puncture (TEP) for voice rehabilitation in laryngectomized patients Blom-Singer vs Provox: Our experience. Medical Journal of the Armed Forces India 2007; 63(1): 15-18.
• Markowski J, Gierek T, Paluch J, Wardas P: The use of the vocal prosthesis Provox 2 for speech rehabilitation after total laryngectomy. Otolaryngologica Polska 2005;59(3):373-7. [Article in Polish]
• Hancock K, Houghton B, Van As-Brooks CJ, Coman W: First clinical experience with a new nonindwelling voice prosthesis (Provox NID) for voice rehabilitation after total laryngectomy. Acta Otolaryngologica 2005 Sep;125(9):981-90.
• Morshed K, Golabek W, Szymanski M, Olszanski W: Speech rehabilitation using Provox voice prosthesis. Otolaryngologica Polska 2005;59(2):225-8. [Article in Polish]
• Ameye D, Honraet K, Loose D, Vermeersch H, Nelis H, Remon JP: Effect of a buccal bioadhesive nystatin tablet on the lifetime of a Provox silicone tracheoesophageal voice prosthesis. Acta Otolaryngologica 2005 Mar;125(3):304-6.
• Kummer P, Chahoud M, Schuster M, Eysholdt U, Rosanowski F: Prosthetic voice rehabilitation after laryngectomy Failures and complications after previous radiation therapy. HNO 2006 April;54(4):315-22. [Article in German]
• Trussart C, Lawson G, Remacle M: Voice prostheses: long-term follow-up retrospective study (three- to sixteen-year follow-up of 22 patients). Revue Laryngologie-Otologie- Rhinologie (Bord) 2003;124(5):299-304.
• Makitie AA, Niemensivu R, Juvas A, Aaltonen LM, Back L, Lehtonen H: Postlaryngectomy voice restoration using a voice prosthesis: a single institution’s ten-year experience. Annals of Otology, Rhinology and Laryngology 2003 Dec;112(12):1007-10.
• Hilgers FJ, Ackerstaff AH, Balm AJ, Van den Brekel MW, Bing Tan I, Persson JO: A new problem-solving indwelling voice prosthesis, eliminating the need for frequent Candida- and “underpressure”-related replacements: Provox ActiValve. Acta Otolaryngologica Oct;123(8):972- 9.
• Free RH, Van der Mei HC, Elving GJ, Van Weissenbruch R, Albers FW, Busscher HJ: Influence of the Provox Flush, blowing and imitated coughing on voice prosthetic biofilms in vitro. Acta Otolaryngologica 2003 May;123(4):547-51.
• Op de Coul BMR, Hilgers FJM, Balm AJM, Tan IB, van den Hoogen FJA, van Tinteren H: A decade of post-laryngectomy vocal rehabilitation in 318 patients: A single institution’s experience with consistent application of Provox® indwelling voice prostheses. Archives of Otolaryngology- Head & Neck Surgery 2000 Nov;126(11):1320-8.
• BalleVH, Rindsø L, Thomsen JC. Primary speech restoration at laryngectomy by insertion of voice prosthesis – 10 years experience. Acta Otolaryngologica 2000; Suppl 543:244-245.
• Ackerstaff AH, Hilgers FJ, Meeuwis CA, van der Velden LA, van den Hoogen FJ, Marres HA, Vreeburg GC, Manni JJ: Multi-institutional assessment of the Provox®2 voice prosthesis. Archives of Otolaryngology - Head & Neck Surgery 1999 Feb;125(2):167-73.
• Laccourreye O, Menard M, Crevier-Buchman L, Couloigner V, Brasnu D: In situ lifetime, causes for replacement, and complications of the Provox® voice prosthesis. Laryngoscope 1997 Apr;107(4):527-30.
• Aust MR, McCaffrey TV: Early speech results with the Provox® [1] prosthesis after laryngectomy. Archives of Otolaryngology - Head & Neck Surgery 1997 Sep;123(9):966-8.
• Hilgers FJM, Ackerstaff AH, Balm AJM, Tan IB, Aaronson NK, Persson JO. Development and clinical evaluation of a second-generation voice prosthesis (Provox®2) designed for anterograde and retrograde insertion. Acta Otolaryngologica 1997; 117: 889-896.
• Hilgers FJM, Balm AJM: Long-term results of vocal rehabilitation after total laryngectomy with the low-resistance, indwelling Provox® voice prosthesis. Clinical Otolaryngology 1993, 18:517- 523.
• Hilgers FJM, Schouwenburg PF. A new low-resistance, self-retaining prosthesis (Provox®) for voice rehabilitation after total laryngectomy. Laryngoscope 1990; 100, 1202-1207.

Provox® HME and Provox FreeHands HME
• Scheenstra RJ, Muller SH, Vincent A, Ackerstaff AH, Jacobi I, Hilgers FJM. Short term endotracheal climate changes and clinical effects of a heat and moisture exchanger with an integrated electrostatic virus and bacterial filter developed for laryngectomized individuals. Acta Otolaryngologica 2009.
• Scheenstra RJ, Muller SH, Vincent A, Sinaasappel M, Zuur JK, Hilgers FJ. Endotracheal temperature and humidity measurements in laryngectomized patients: intra- and inter-patient variability. Medical & Biological Engineering & Computing 2009 Jul;47(7):773-82.
• Scheenstra RJ, Muller SH, Vincent A, Sinaasappel M, Hilgers FJ. Influence of breathing resistance of heat and moisture exchangers on tracheal climate and breathing pattern in laryngectomized individuals. Head & Neck 2009 December [Epub ahead of print]
• Bien S, Okla S, van As-Brooks CJ, Ackerstaff AH. The effect of a Heat and Moisture Exchanger (Provox HME) on pulmonary protection after total laryngectomy: a randomized controlled study. . European Archives of Otorhinolaryngology 2010 March;267(3):429-35.
• Hamade, R., Hewlett, N., & Scanlon, E. (2006). A quantitative and qualitative evaluation of an automatic occlusion device for tracheoesophageal speech: the Provox FreeHands HME. Clinical Linguists and Phonetics , 20, 187-193.
• Hilgers, F. J. & Ackerstaff, A. H. Development and evaluation of a novel tracheostoma button and fixation system (Provox LaryButton and LaryClip adhesive) to facilitate hands-free tracheoesophageal speech. Acta Otolaryngologica 2006 Dec; 126(11): 1218-1224.
• Zuur JK, Muller SH, Sinaasappel M. Hart GA, Van Zandwijk N, Hilgers FJ. Influence of heat and moisture exchanger respiratory load on transcutaneou oxygenation in laryngectomized individuals: a randomized cross-over study. Head & neck 2007 Dec; 29(12): 1102-1110.
• Zuur JK, Muller SH, Vincent A, Sinaasappel M, de Jongh FH, Hilgers FJ. Assessment of tracheal temperature and humidity in laryngectomized individuals and the influence of a heat and moisture exchanger on tracheal climate. Head & Neck 2008 Aug; 30(8): 1072-1082.
• Lorenz KJ, Huverstuhl K, Maier H. [Finger-free speech with the Provox FreeHands HME Automatic Tracheostoma Valve system. Clinical long-term experience]. HNO 2009;57(11):1090- 1098.
• Zuur JK, Muller SH, Vincent A, Sinaasappel M, de Jongh FH, Hilgers FJ. The influence of a heat and moisture exchanger on tracheal climate in a cold environment. Medical & Biological Engineering & Computing 2009 Sep;31(7):852-7. Epub 2009 May 28.
• Lorenz KJ, Maier H. [Pulmonary rehabilitation after total laryngectomy using a heat and moisture exchanger (HME)]. Laryngorhinootologie 2009;88(8):513-522.
• Lorenz KJ, Ackerstaff AH, Hilgers FJM, Maier H. Hands-free speech after surgical voice rehabilitation with a Provox® voice prosthesis: experience with the Provox® Freehands™ HME tracheostoma valve system. European Archives of Otorhinolaryngology 2007 Feb; 264(2):151- 157.
• Hilgers FJM, Ackerstaff AH, Balm AJM, Gregor RT. A new heat and moisture exchanger with speech valve (Provox® [HME] Stomafilter). Clinical Otolaryngology 1996; 21: 414-418.
• Op de Coul BM, Ackerstaff AH, van As-Brooks CJ, van den Hoogen FJ, Meeuwis CA, Manni JJ, Hilgers FJ. Compliance, quality of life and quantitative voice quality aspects of hands-free speech. Acta Otolaryngologica 2005 Jun;125(6):629-37.
• Zuur JK, Muller SH, de Jongh FH, van Zandwijk N, Hilgers FJ: The physiological rationale of heat and moisture exchangers in post-laryngectomy pulmonary rehabilitation: a review. European Archives of Otorhinolaryngology 2006 Jan;263(1):1-8.
• Tervonen H, Back L, Juvas A, Rasanen P, Makitie AA, Sintonen H, Roine RP, Vilkman E, Aaltonen LM: Automatic speaking valve in speech rehabilitation for laryngectomized patients. European Archives of Otorhinolaryngology 2005 Oct;262(10):816-20. Epub 2005 Mar 1
• Ackerstaff AH, Fuller D, Irvin M, Maccracken E, Gaziano J, Stachowiak L: Multicenter study assessing effects of heat and moisture exchanger use on respiratory symptoms and voice quality in laryngectomized individuals. Otolaryngology Head & Neck Surgery 2003 Dec;129(6):705-12
• Hilgers FJ, Ackerstaff AH, Van As CJ, Balm AJ, Van den Brekel MW, Tan IB: Development and clinical assessment of a heat and moisture exchanger with a multi-magnet automatic tracheostoma valve (Provox FreeHands HME) for vocal and pulmonary rehabilitation after total laryngectomy. Acta Otolaryngologica 2003 Jan;123(1):91-9
• Herranz Gonzalez-Botas J, Suarez T, Garcia Carreira B, Martinez Moran A. Experience with the HME-Provox® Stomafilter in laryngectomized patients. Acta Otorrinolaringologica Espana 2001 Apr;52(3):221-5 [Spanish]
• van As CJ, Hilgers FJM, Koopmans-van Beinum FJ, Ackerstaff AH. The influence of stoma occlusion on aspects of alaryngeal speech. Acta Otolaryngologica 1998; 118: 732-738.
• Ackerstaff AH, Hilgers FJM, Balm AJM, Tan IB. Long term compliance of laryngectomized patients with a specialized pulmonary rehabilitation device, Provox® [HME] Stomafilter. Laryngoscope 1998; 108: 257-260.
• Hilgers FJM, Ackerstaff AH, Balm AJM, Gregor RT. A new heat and moisture exchanger with speech valve (Provox® [HME] Stomafilter). Clinical Otolaryngology 1996; 21: 414-418.
• Ackerstaff AH, Hilgers FJM, Aaronson NK, de Boer MF, Meeuwis CA, Knegt PPM, Spoelstra HAA, van Zandwijk N, Balm AJM. Heat and moisture exchangers as a preventative treatment option in the rehabilitation of laryngectomized patients. Clinical Otolaryngology 1995; 20: 504-509
• Ackerstaff AH, Hilgers FJM, Aaronson NK, Balm AJM, van Zandwijk N. Improvements in respiratory and psychosocial functioning following total laryngectomy by the use of a heat and moisture exchanger (HME). Annals of Otology, Rhinology and Laryngology 1993; 102: 878-883.
• Hilgers FJM, Aaronson NK, Ackerstaff AH, Schouwenburg PF, van Zandwijk N. The influence of a heat and moisture exchanger (HME) on the respiratory symptoms after total laryngectomy. Clinical Otolaryngology 1991; 16: 152-156.

Oralmaxillofacial articles

TheraBite

1. Buchbinder D, Currivan RB, Kaplan AJ, Urken ML. Mobilization regimens for the prevention of jaw hypomobility in the radiated patients. A comparison of three techniques. Journal of Oralmaxillofacial Surgery. 1993; 51:863-867.
2. Cohen EG, Deschler DG, Walsh K, Hayden RE. Early use of a mechanical stretching device to improve mandibular mobility after composite resection: a pilot study. Arch Phys Med Rehabil. 2005 Jul;86(7):1416-9.
3. Dijkstra PU, Kalk WW, Roodenburg JL. Trismus in head and neck oncology: a systematic review. Journal: Oral Oncol. 2004 Oct; 40(9):879-89.
4. Maloney GE, Mehta N, Forgione AG, Zazawi KH, Al-Badawi EA, Driscoll SE. Effects of a passive jaw motion device on pain and range of motion in TMD patients not responding to flat plane intraoral appliances. The Journal of CranioMandibular Practice, 2002; 20:55-66.
5. Messing BP, Saunders JR, Dietrich-Burns K, Farrell SS, Pyrke-Fairchild J, Melick CF. Trismus management in the head and neck cancer patient undergoing organ preservation treatment. 6th International Conference on Head and Neck Cancer, Washington DC, USA
August 07-11, 2004. Scientific Poster 01-97.
6. Bandy WD, Irion JM, Briggler M. The effect of static stretch on the flexibility of the hamstring muscles. Physical Therapy 1997; 77: 1090-1096.
7. Cohen GS, Fletcher M. Comparison of Jaw Mobilization Regimens. Journal of Dental Research, 1991; 70:329.
8. Dijkstra, PU, Huisman, PM, and Roodenburg, JL Criteria for trismus in head and neck oncology Int.J.Oral Maxillofac. Surg., 35[4], 337-342. 2006.
9. Dijkstra, PU, Sterken, MW, Pater, R, Spijkervet, FK, and Roodenburg, JL Exercise therapy for trismus in head and neck cancer Oral Oncol., 43[4], 389-394. 2007.
10. Jager-Wittenaar, H, Dijkstra, PU, Vissink, A, van Oort, RP, and Roodenburg, JL. Variation in repeated mouth-opening measurements in head and neck cancer patients with and without trismus Int.J.Oral Maxillofac. Surg., 38[1], 26-30. 2009.
11. Kent ML, Brennan, MT, Noll, JL, Fox, PC, Burri, SH, Hunter, JC, and Lockhart, PB. Radiation-induced trismus in head and neck cancer patients Support.Care Cancer, 16[3], 305-309. 2008.
12. Scott, B, Butterworth, C, Lowe, D, and Rogers, SN. Factors associated with restricted mouth opening and its relationship to health-related quality of life in patients attending a Maxillofacial Oncology clinic Oral Oncol., 44[5], 430-438. 2008.
13. Teguh, DN, Levendag, PC, Voet, P, van der Est, H, Noever, I, de Kruijf, W, van Rooij, P, Schmitz, PI, and Heijmen, BJ. Trismus in patients with oropharyngeal cancer: relationship with dose in structures of mastication apparatus Head Neck, 30[5], 622-
630. 2008.
14. Gibbons, A. J. and Abulhoul, S. Use of a Therabite appliance in the management of bilateral mandibular coronoid hyperplasia Br.J.Oral Maxillofac.Surg., 45[6], 505-506. 2007.