PRCT: Ligament Reconstruction & Tendon Interposition With a Joint Spacer for Trapeziometacarpal OA
NCT ID: NCT00671333
Last Updated: 2018-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
82 participants
INTERVENTIONAL
2008-04-30
2017-11-14
Brief Summary
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The hypothesis is that insertion of a spacer will provide similar symptomatic relief, but improved long term gains in key and tripod pinch strength when compared to LRTI.
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Detailed Description
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There is controversy regarding the best treatment of this condition and many surgical techniques are in common use.
One of these involves removing the wrist bone (trapezium) at the base of the thumb and, using a tendon from the forearm, reconstructing an important ligament, which contributes to the stability of the thumb. This is known as a Ligament Reconstruction and Tendon Interposition (LRTI).
A newer type of operation involves the insertion of a Ascension PyroDisk which is made from a thick pyrocarbon layer encasing a graphite core with a small amount of tungsten. These materials have been shown to be safe when implanted in the body. The PyroDisk is a disk shaped design which has a curved surface designed to fit between the bony surfaces of the trapezium and the metacarpal, reducing pain and allowing for full movement of the joint. It contains a hole in the center through which a strip of tendon can be passed and helps hold the disk in place.
This research study is designed to determine the effectiveness of the Ascension PyroDisk spacer when compared to the LRTI procedure described above. The effectiveness of both of these procedures will be determined by comparing range of motion, grip and pinch strength, x-rays, function and return to work. It is important to compare both procedures, as it is not known which procedure is the most effective.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
(LRTI) Ligament reconstruction and tendon interposition
LRTI
Dorsal radial incision, capsulotomy between EPB and APL protecting the radial artery, trapeziectomy using a cruciate osteotomy and rongeurs, creation of a metacarpal base bone tunnel using a high speed burr, harvesting of entire FCR tendon through two transverse volar incisions, ligament reconstruction and tendon interposition using "Fibre Wire" suture. Closure of capsule with Vicryl. Closure of skin with running Prolene suture.
2
Ascension PyroDisk
Ascension PyroDisk
Dorsal radial incision, capsulotomy between EPB and APL protecting the radial artery, distal 2 mm of trapezium and dorsal cortex of both trapezium and metacarpal removed using osteotomes/rongeurs. A hole is drilled through the trapezium from dorsal to resected distal surface, and a second hole is drilled through the first metacarpal from the resected base to the dorsal surface. A slip of FCR is harvested. The tendon is woven through the trapezium, the central hole in the device, and the metacarpal tunnel then sutured back onto itself. Closure of capsule with Vicryl. Closure of skin with running Prolene suture.
Interventions
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LRTI
Dorsal radial incision, capsulotomy between EPB and APL protecting the radial artery, trapeziectomy using a cruciate osteotomy and rongeurs, creation of a metacarpal base bone tunnel using a high speed burr, harvesting of entire FCR tendon through two transverse volar incisions, ligament reconstruction and tendon interposition using "Fibre Wire" suture. Closure of capsule with Vicryl. Closure of skin with running Prolene suture.
Ascension PyroDisk
Dorsal radial incision, capsulotomy between EPB and APL protecting the radial artery, distal 2 mm of trapezium and dorsal cortex of both trapezium and metacarpal removed using osteotomes/rongeurs. A hole is drilled through the trapezium from dorsal to resected distal surface, and a second hole is drilled through the first metacarpal from the resected base to the dorsal surface. A slip of FCR is harvested. The tendon is woven through the trapezium, the central hole in the device, and the metacarpal tunnel then sutured back onto itself. Closure of capsule with Vicryl. Closure of skin with running Prolene suture.
Eligibility Criteria
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Inclusion Criteria
* duration of symptoms of at least six months
* failure to respond to non-operative management
* age 50 or older
* less than 30 degrees of ipsilateral MCP hyperextension
* British Columbian resident living in the Lower Mainland and available for protocol follow-up
Exclusion Criteria
* other significant ipsilateral wrist or hand pathology
* a history of inflammatory arthropathy
* a requirement for concommitant surgery for another condition
* any previous hand or wrist fracture
50 Years
ALL
No
Sponsors
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Fraser Orthopaedic Research Society
NETWORK
Responsible Party
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Principal Investigators
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Bertrand H Perey, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Columbian Hospital, Eagle Ridge Hospital
Locations
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Royal Columbian Hospital
New Westminster, British Columbia, Canada
Eagle Ridge Hospital
Port Moody, British Columbia, Canada
Countries
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References
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Armstrong AL, Hunter JB, Davis TR. The prevalence of degenerative arthritis of the base of the thumb in post-menopausal women. J Hand Surg Br. 1994 Jun;19(3):340-1. doi: 10.1016/0266-7681(94)90085-x.
Eaton RG, Littler JW. Ligament reconstruction for the painful thumb carpometacarpal joint. J Bone Joint Surg Am. 1973 Dec;55(8):1655-66. No abstract available.
Wilson JN, Bossley CJ. Osteotomy in the treatment of osteoarthritis of the first carpometacarpal joint. J Bone Joint Surg Br. 1983 Mar;65(2):179-81. doi: 10.1302/0301-620X.65B2.6826626.
Carroll RE, Hill NA. Arthrodesis of the carpo-metacarpal joint of the thumb. J Bone Joint Surg Br. 1973 May;55(2):292-4. No abstract available.
Burton RI, Pellegrini VD Jr. Surgical management of basal joint arthritis of the thumb. Part II. Ligament reconstruction with tendon interposition arthroplasty. J Hand Surg Am. 1986 May;11(3):324-32. doi: 10.1016/s0363-5023(86)80137-x.
GERVIS WH. Excision of the trapezium for osteoarthritis of the trapezio-metacarpal joint. J Bone Joint Surg Br. 1949 Nov;31B(4):537-9, illust. No abstract available.
Swanson AB. Disabling arthritis at the base of the thumb: treatment by resection of the trapezium and flexible (silicone) implant arthroplasty. J Bone Joint Surg Am. 1972 Apr;54(3):456-71. No abstract available.
Cooney WP, Linscheid RL, Askew LJ. Total arthroplasty of the thumb trapeziometacarpal joint. Clin Orthop Relat Res. 1987 Jul;(220):35-45.
Tomaino MM, Pellegrini VD Jr, Burton RI. Arthroplasty of the basal joint of the thumb. Long-term follow-up after ligament reconstruction with tendon interposition. J Bone Joint Surg Am. 1995 Mar;77(3):346-55. doi: 10.2106/00004623-199503000-00003.
Low AK, Edmunds IA. Isolated scaphotrapeziotrapezoid osteoarthritis: preliminary results of treatment using a pyrocarbon implant. Hand Surg. 2007;12(2):73-7. doi: 10.1142/S0218810407003523.
Nunez VA, Citron ND. Short-term results of the Ascension pyrolytic carbon metacarpophalangeal joint replacement arthroplasty for osteoarthritis. Chir Main. 2005 Jun-Aug;24(3-4):161-4. doi: 10.1016/j.main.2005.04.009.
Heers G, Grifka J, Borisch N. [First results after implantation of a pyrocarbon-endoprosthesis in patients with degenerative arthritis]. Z Orthop Ihre Grenzgeb. 2006 Nov-Dec;144(6):609-13. doi: 10.1055/s-2006-955189. German.
Beckenbaugh RD. [Arthroplasty of the metacarpophalangeal joint using pyrocarbonate implants]. Orthopade. 2003 Sep;32(9):794-7. doi: 10.1007/s00132-003-0519-x. German.
Other Identifiers
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2006-060
Identifier Type: -
Identifier Source: org_study_id
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