The anterior vs the posterolateral approach for THA: is there a difference in tissue damage?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24737

Enrollment

Registered

2013-03-27

Start date

2013-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

total hip arthroplasty (THA)

Interventions

Patients in the study group will undergo THA using the minimally invasive single-incision anterior approach. An anterior incision centred over the hip joint is made in a supine patient. After division

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 90 years; 2. Indication for THA is primary or secondary symptomatic osteoarthritis.

Exclusion criteria

Exclusion criteria: 1. A history of previous surgery on the ipsilateral hip; 2. Peripheral neuropathy; 3. (Active) arthritis (e.g. rheumatic disease); 4. A history of CVA; 5. Cognitive impairments.

Design outcomes

Primary

Measure	Time frame
Tissue damage will be assessed via the enumeration of the tissue macrophages in blood (over time), preferably also using specific antibodies against fragments of tissue-specific proteins, such as soft tissue and skeletal muscle. Multiparameter (≥ 8 colors) flow cytometry can accurately detect and identify the circulating tissue macrophages with a first set of antibodies against membrane markers. The absolute and relative numbers of the blood tissue macrophages during and after the THA procedure should be able to give insight into the extent of tissue damage in individual patients. In addition, the levels of serum creatine kinase (CK), creatine phosphokinase (CPK), and C-reactive protein (CRP) will be assessed.	—

Measure

Time frame

Tissue damage will be assessed via the enumeration of the tissue macrophages in blood (over time), preferably also using specific antibodies against fragments of tissue-specific proteins, such as soft tissue and skeletal muscle. Multiparameter (≥ 8 colors) flow cytometry can accurately detect and identify the circulating tissue macrophages with a first set of antibodies against membrane markers. The absolute and relative numbers of the blood tissue macrophages during and after the THA procedure should be able to give insight into the extent of tissue damage in individual patients. In addition, the levels of serum creatine kinase (CK), creatine phosphokinase (CPK), and C-reactive protein (CRP) will be assessed.

—

Secondary

Measure	Time frame
Besides a relative and quantitative assessment, the secondary study parameter will be the presence of bone- and muscle- specific protein fragments in the circulating macrophages. The presence of these fragments, might be related to the extent of bone and muscle damage, potentially allowing a more accurate assessment of damage caused by the different THA approaches.	—

Contacts

Public ContactI.H.F. Reininga

Martini Hospital Groningen Dept. of Orthopaedics P.O. Box 30033

i.reininga@mzh.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)