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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01344421
Other study ID # M-20100206
Secondary ID
Status Completed
Phase N/A
First received April 27, 2011
Last updated April 4, 2013
Start date March 2011
Est. completion date March 2013

Study information

Verified date April 2013
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

The purpose of this study is to examine the movement pattern in patients with hip dysplasia preoperative, six and 12 month after minimally invasive approach for Periacetabular osteotomy (PAO). Secondary to examine the movement pattern in patients compared to healthy controls and historical data.


Description:

Congenital hip dysplasia is a disease characterised by pathological changes in the hip joint. Hip dysplasia is a normal disease with a prevalence of 4.3% in men and 3.6 in woman. Untreated hip dysplasia is a known cause of developing osteoarthritis early in life and symptoms as pain, hip instability together with a changed gait pattern are normal. Symptomatic hip dysplasia is seen in patients between 15 and 55 years and can be unilateral as well as bilateral. Causes of hip dysplasia are described as genetic, mechanic or hormonal.

Today patients with hip dysplasia are offered a hip conserving surgery before the osteoarthritis has developed. In 2003 a minimally invasive approach for periacetabular osteotomy (PAO) was introduced at Aarhus University Hospital. An advantage of minimally invasive approach compared to the classical Bernese periacetabular osteotomy is minimal impact of the soft tissues in the hip region.

Hip pain and activity limitations highly affect quality of life and physical function. The gait distance is reduced and patients have to compensate to relieve the pressure on the hip joint. Knowledge about the dynamics of the gait and running pattern in patients with dysplasia is important to understand the consequences of the dysplastic hip joint. Furthermore knowledge about gait compensations is relevant for the clinicians in the management and treatment of patients with hip dysplasia.

Today, gait and running compensation is unknown after minimally invasive approach The purpose of this study is, therefore, to examine the movement pattern in patients with hip dysplasia preoperative, six and 12 month after minimally invasive approach for Peri-acetabular osteotomy (PAO). Secondary to examine the movement pattern in patients compared to healthy controls and historical data.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Patients diagnosed with hip dysplasia

- Patients in the age of 18-60 years

- Patients, who can speak, understand and read Danish

Exclusion Criteria:

- Persons with hip dysplasia secondary to other hip conditions such as Calvé Perthes and epiphysiolysis.

- Persons who have had alloplastic surgery in the hip, knee or ankle.

- Persons with diseases that affect the gait pattern.

- Persons with serious hip, knee, ankle or back pain.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Procedure:
Minimally invasive approach for Periacetabular osteotomy
A peri-acetabular osteotomy is a surgery performed to correct the dysplastic acetabulum and reduce joint contact pressures and early osteoarthritis.

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (1)

Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hip flexion's muscle moment in stance evaluated in gait, run and jump test Examined using 3D Movement Capture System Preoperative (baseline), 6 and 12 month postoperative No
Secondary Hip extension angle evaluated in gait, run and jump test Examined using 3D Movement Capture Systen Preoperative (baseline), 6 and 12 month postoperative No
Secondary On-set of the hip muscles evaluated in gait, run and jump test Examined using skin electromyography (EMG) Preoperative (baseline), 6 and 12 month postoperative No
Secondary Function, sports and recreational activities Evaluated with Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and The Copenhagen Hip and Groin Outcome Score (HAGOS) Preoperative (baseline), 6 and 12 month postoperative No
Secondary Quality of life Evaluated with Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and The Copenhagen Hip and Groin Outcome Score (HAGOS) preoperative (baseline), 6 and 12 month postoperative No
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