NCT00671333

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2008

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2017

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

9.6 years

First QC Date

May 1, 2008

Last Update Submit

April 30, 2018

Conditions

Joint Disease

Keywords

RandomizedProspectiveProcedure / Surgery

Outcome Measures

Primary Outcomes (1)

  • Patient Rated Wrist Evaluation (PRWE) at baseline, 6 weeks, 3, 6 and 12 months post-operatively.

    Subjects are followed for 12 months post-op.

Secondary Outcomes (1)

  • Wrist range of motion, grip strength, radiographs, and pain Visual Analog Scale.

    Baseline, 6 weeks, 3,6 and 12 months.

Study Arms (2)

1

ACTIVE COMPARATOR

(LRTI) Ligament reconstruction and tendon interposition

Procedure: LRTI

2

ACTIVE COMPARATOR

Ascension PyroDisk

Procedure: Ascension PyroDisk

Interventions

LRTIPROCEDURE

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.

1
Ascension PyroDiskPROCEDURE

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.

2

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Eagle Ridge Hospital

Port Moody, British Columbia, V3H 3W9, Canada

Location

Related Publications (13)

  • 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.

    PMID: 8077824BACKGROUND

  • 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.

    PMID: 4804988BACKGROUND

  • 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.

    PMID: 6826626BACKGROUND

  • 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.

    PMID: 4707297BACKGROUND

  • 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.

    PMID: 3711604BACKGROUND

  • 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.

    PMID: 15397137BACKGROUND

  • 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.

    PMID: 5055148BACKGROUND

  • Cooney WP, Linscheid RL, Askew LJ. Total arthroplasty of the thumb trapeziometacarpal joint. Clin Orthop Relat Res. 1987 Jul;(220):35-45.

    PMID: 3595008BACKGROUND

  • 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.

    PMID: 7890782BACKGROUND

  • 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.

    PMID: 18098356BACKGROUND

  • 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.

    PMID: 16121621BACKGROUND

  • 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.

    PMID: 17187336BACKGROUND

  • 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.

    PMID: 14508645BACKGROUND

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

  • Bertrand H Perey, MD

    Royal Columbian Hospital, Eagle Ridge Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2008

First Posted

May 5, 2008

Study Start

April 1, 2008

Primary Completion

November 14, 2017

Study Completion

November 14, 2017

Last Updated

May 2, 2018

Record last verified: 2018-04

Locations

CA(2)