Proximal Row Carpectomy Versus Four Corner Fusion

Wrist Osteoarthritis Clinical Trial

Official title:

Comparison of Subjective, Radiological and Functional Results After Proximal Row Carpectomy and Four Corner Fusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906996
• Other study ID #: PRC01
• Status: Completed
• Phase: N/A
• First received: July 11, 2013
• Last updated: February 26, 2014
• Start date: July 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Kantonale Ethikkommission Zürich
• Study type: Observational

Clinical Trial Summary

There are two types of interventions to treat a post-traumatic wrist osteoarthritis: the proximal row carpectomy and the four corner fusion. They are used to reduce pain and to maintain the mobility. In previous studies are shown that the proximal row carpectomy shows a better mobility of the wrist postoperatively, whereas the four corner fusion has lower progression of radiocarpale osteoarthritis.

The purpose of this study is to compare the clinical, radiological and subjective outcomes after the treatment with a proximal row carpectomy or a four corner fusion.

Description:

Two surgical procedures are used to treat a post-traumatic wrist osteoarthritis, especially after scaphoid non-union advanced collapse (SNAC) and scapholunate advanced collapse (SLAC): the proximal row carpectomy and the four corner fusion. Both surgical procedures are rescue operations. They are used to reduce pain and to maintain the mobility, compared to a complete stiffening of the wrist.

In previous studies are shown that the proximal row carpectomy shows a better mobility of the wrist postoperatively and a lower complication rate, whereas the four corner fusion has a lower progression of radiocarpale osteoarthritis and a better grip strength.

The purpose of this study is to compare the clinical, radiological and subjective outcomes after the treatment with a proximal row carpectomy or a four corner fusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• post-traumatic wrist osteoarthritis

• treated with a proximal row carpectomy or four corner fusion

• signed written informed consent

Exclusion Criteria:

• no knowledge of German

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Wrist Osteoarthritis

Intervention

Procedure:
• proximal row carpectomy
excision of the scaphoid, lunate and triquetrum
• four corner fusion
excision of the scaphoid and stiffening of the lunate, capitate and triquetrum by a plate

Locations

Country	Name	City	State
Switzerland	Schulthess Klinik	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Schulthess Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	grip strength	measurement of grip strength	participants will be followed up by an expected average of 4.5 years	No
Other	Patient-Rated Wirst Evaluation (PRWE)	Comparison of proximal row carpectomy and four corner fusion in respect to PRWE	participants will be followed up by an expected average of 4.5 years	No
Other	Michigan Hand Outcomes Questionnaire (MHQ)	Comparison of proximal row carpectomy and four corner fusion in respect to MHQ	participants will be followed up by an expected average of 4.5 years	No
Other	Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)	Comparison of proximal row carpectomy and four corner fusion in rsespect to QuickDASH	participants will be followed up by an expected average of 4.5 years	No
Other	Detection of radiological parameters	Detection of arthrosis fossa lunata, impingement and loosening	participants will be followed up by an expected average of 4.5 years	No
Primary	Range of motion of the wrist	measurements of flexion/extension,supination/pronation and radial-/ulnarduction of the wrist	participants will be followed up by an expected average of 4.5 years	No
Secondary	complication rate	Detection of complications of both surgical procedures	participants will be followed up by an expected average of 4.5 years	No