Clinical trial NCT02294890: Knee Stiffness in Fibrosis Diathesis
Official title: Does Fibrosis Diathesis Influence the Recovery of Knee Mobility After Total Knee Replacement?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Replacement Arthroplasty
Fibrosis
Dupuytren's Disease
Lead sponsor: University Hospital Pellenberg
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who undergo a total knee arthroplasty for primary gonarthrosis at a minimal age of 50 years showing signs of fibrosis diathesis at presentation can be included. Patients who do not show signs of fibrosis diathesis will serve as a control group.

Brief 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.


Eligibility criteria: 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,...

Primary outcomes:
measure: Range of movement of the operated knee at 12 months postoperatively
timeFrame: 12 months
measure: Additional procedures/interventions to gain motion
timeFrame: 12 months
Secondary outcomes:
measure: - Increase of contracture or appearance of the nodules and contractures in the hand after the knee surgery.
timeFrame: 12 months
measure: KSS score for knee function
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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. doi: 10.1016/j.jhsb.2004.06.004.
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. doi: 10.1016/j.jhsa.2006.09.006.
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.
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.
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. doi: 10.1067/mse.2001.112883.