Knee Stiffness in Fibrosis Diathesis

Fibrosis Clinical Trial

Official title:

Does Fibrosis Diathesis Influence the Recovery of Knee Mobility After Total Knee Replacement?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02294890
• Other study ID #: UHPellenberg
• Status: Not yet recruiting
• Phase: N/A
• First received: November 5, 2014
• Last updated: November 15, 2014
• Start date: January 2015
• Est. completion date: April 2015

Study information

• Verified date: November 2014
• Source: University Hospital Pellenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

At the standard follow-up moment one year after primary TKA for gonarthrosis, all patients will be checked for signs of fibrosis diathesis. This will be done by examining their hands for Dupuytren's nodules and contractures and recording risk factors associated with increased severity and risk of recurrence of Dupuytren's contracture. These include family history, bilateral DD, and ectopic lesions, age of onset less than 50 years, male gender, Ledderhose disease, first ray involvement, multiple ray involvement and ectopic fibromatosis.

This way, two groups of patients will be identified: those with and those without signs of fibrosis diathesis. For both groups, the range of motion (ROM) of the operated knee at 3 and 6 months will be retrieved in the charts, the ROM at 12 months will be measured at that time. Also, additional procedures performed to increase ROM postoperatively will be retrieved from the charts (e.g. continuous passive motion, mobilization under anesthesia). Other causes for knee stiffness will have to be recorded, since these will be the most important exclusion criteria.

In the patients with clear signs of finger contractures, any impression of increase of contracture over the past 12 months will be recorded.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing a total knee replacement for primary gonarthrosis with a minimum follow-up of 1 year

Exclusion Criteria:

• Patients undergoing a TKA for other reasons than primary gonarthrosis, e.g. after infection, posttraumatic arthritis,hemophilia,…

• Patients who had other problems after their TKA resulting in knee stiffness, e.g. infection, bleeding,…

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dupuytren Contracture
• Dupuytren's Disease
• Fibrosis
• Knee Replacement Arthroplasty

Intervention

Procedure:
• Total knee arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Pellenberg

References & Publications (5)

Abe Y, Rokkaku T, Ofuchi S, Tokunaga S, Takahashi K, Moriya H. An objective method to evaluate the risk of recurrence and extension of Dupuytren's disease. J Hand Surg Br. 2004 Oct;29(5):427-30. — View Citation

Hindocha S, Stanley JK, Watson S, Bayat A. Dupuytren's diathesis revisited: Evaluation of prognostic indicators for risk of disease recurrence. J Hand Surg Am. 2006 Dec;31(10):1626-34. — View Citation

Issa K, Rifai A, Boylan MR, Pourtaheri S, McInerney VK, Mont MA. Do various factors affect the frequency of manipulation under anesthesia after primary total knee arthroplasty? Clin Orthop Relat Res. 2015 Jan;473(1):143-7. doi: 10.1007/s11999-014-3772-x. — View Citation

Lungu E, Desmeules F, Dionne CE, Belzile EL, Vendittoli PA. Prediction of poor outcomes six months following total knee arthroplasty in patients awaiting surgery. BMC Musculoskelet Disord. 2014 Sep 8;15:299. doi: 10.1186/1471-2474-15-299. — View Citation

Smith SP, Devaraj VS, Bunker TD. The association between frozen shoulder and Dupuytren's disease. J Shoulder Elbow Surg. 2001 Mar-Apr;10(2):149-51. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of movement of the operated knee at 12 months postoperatively		12 months	No
Primary	Additional procedures/interventions to gain motion		12 months	No
Secondary	- Increase of contracture or appearance of the nodules and contractures in the hand after the knee surgery.		12 months	No
Secondary	KSS score for knee function		12 months	No