Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2-3

Trapeziometacarpal Osteoarthritis Clinical Trial

Official title:

Total Joint Arthroplasty or Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2 and 3: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02204488
• Other study ID #: NL47755.075.14
• Secondary ID: NL47755.075.14
• Status: Recruiting
• Phase: N/A
• First received: July 29, 2014
• Last updated: September 2, 2016
• Start date: September 2014
• Est. completion date: September 2021

Study information

• Verified date: September 2016
• Source: Isala
• Contact: Ramon P. de Wildt, MD
• Email: r.p.de.wildt[@]isala.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. A relatively new treatment modality, which has been further developed in recent years is the total joint arthroplasty. Randomized prospective trials and long-term results are lacking, but prospective cohorts show a faster recovery and good results after one year, without an increase in complication rate.

We hypothesize that a total joint arthroplasty gives a better objective and subjective result after one year than a trapeziectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: September 2021
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Women.

• 40 years of age or more.

• Symptomatic trapeziometacarpal osteoarthritis.

• Eaton & Glickel stage 2 and 3.

Exclusion Criteria:

• An operation for trapeziometacarpal osteoarthritis on the same hand in the past.

• Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand.

• Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout.

• Symptomatic carpal tunnel syndrome in same hand.

• Symptomatic Quervain's tenosynovitis in same hand.

• Neurological or other disorders of the affected side that can influence postoperative rehabilitation.

• Insufficient knowledge of Dutch language.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Thumb Carpometacarpal Osteoarthritis
• Trapeziometacarpal Osteoarthritis

Intervention

Procedure:
• Total Joint Arthroplasty
Total Joint Arthroplasty with device: Maïa® trapezio-metacarpal joint prosthesis, Groupe Lépine, Genay, France
• Trapeziectomy
Trapeziectomy

Locations

Country	Name	City	State
Netherlands	Isala Hospital	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Isala

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Michigan Hand Outcomes Questionnaire (MHOQ)	Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 year postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?	1 year after surgery	No
Secondary	Michigan Hand Outcomes Questionnaire (MHOQ)	Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 5 years postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?	5 years after surgery	No
Secondary	Michigan Hand Outcomes Questionnaire (MHOQ)	Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years postoperatively, measured with the different subscales (i.e. pain) of the Michigan Hand Outcomes Questionnaire (MHOQ)?	1 and 5 years after surgery	No
Secondary	Disabilities of Arm Shoulder and Hand (DASH)	Is there a difference is daily hand function after 1 and 5 years postoperatively between patients with a total joint arthroplasty and patients with a trapeziectomy measured with the Disabilities of Arm Shoulder and Hand (DASH)?	1 and 5 years after surgery	No
Secondary	Grip strength	Is there a difference in grip strength between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?	1 and 5 years after surgery	No
Secondary	Thumb mobility	Is there a difference in mobility of the thumb between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?	1 and 5 years after surgery	No
Secondary	Complications	Is there a difference in postoperative complications between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?	1 and 5 years after surgery	No
Secondary	Return to work	Is there a difference in return to work between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?	1 and 5 years after surgery	No