Clinical trial NCT00671333: PRCT: Ligament Reconstruction & Tendon Interposition With a Joint Spacer for Trapeziometacarpal OA
Official title: A Randomized Prospective Study Comparing Ligament Reconstruction and Tendon Interposition (LRTI) With a Joint Spacer (Ascension PyroDisk) for Trapeziometacarpal Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Joint Disease
Keywords: Randomized
Prospective
Procedure / Surgery
Lead sponsor: Fraser Orthopaedic Research Society
Sponsor class: NETWORK
First posted: 2008-05-05
Enrollment: 82
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of two types of operative treatment in terms of resolving symptoms, improving function and also with respect to x-ray outcomes.

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.

Detailed description: Trapeziometacarpal (TMC) arthritis is a common condition, which occurs when the cartilage (tissue) covering the bones at the joint at the base of the thumb wear away. This condition occurs in 10% of women and 1% of men.

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.

Eligibility criteria: Inclusion Criteria:

* isolated trapeziometacarpal osteoarthritis
* 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:

* previous surgery for TMC arthritis
* 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

Primary outcomes:
measure: Patient Rated Wrist Evaluation (PRWE) at baseline, 6 weeks, 3, 6 and 12 months post-operatively.
timeFrame: Subjects are followed for 12 months post-op.
Secondary outcomes:
measure: Wrist range of motion, grip strength, radiographs, and pain Visual Analog Scale.
timeFrame: Baseline, 6 weeks, 3,6 and 12 months.
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Port Moody
country: Canada
facility: Eagle Ridge Hospital
state: British Columbia
Study officials:
affiliation: Royal Columbian Hospital, Eagle Ridge Hospital
name: Bertrand H Perey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Cooney WP, Linscheid RL, Askew LJ. Total arthroplasty of the thumb trapeziometacarpal joint. Clin Orthop Relat Res. 1987 Jul;(220):35-45.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.