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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45056

Enrollment

Registered

2013-10-17

Start date

2014-09-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

osteoarthritis of the hip joint

Interventions

Patients in the study group will undergo THA using the minimally invasive single-incision anterior approach. This approach will be compared to the conventional posterolateral approach for THA.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age between 18 * 90 years; - Indication for THA is primary or secondary symptomatic osteoarthritis of the hip joint

Exclusion criteria

Exclusion criteria: - A history of previous surgery on the ipsilateral hip; - peripheral neuropathy; - (active) arthritis (e.g. rheumatic disease); - a history of CVA; - a contraindication for MRI; - cognitive impairments.

Design outcomes

Primary

Measure	Time frame
The levels of serum creatine kinase (CK), creatine phosphokinase (CPK), and C-reactive protein (CRP) will be assessed. For the pilot study the reliability of macrophage and monocyte measurements will be assessed.	—

Secondary

Measure	Time frame
Tissue damage will additionally 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. A second set of antibodies will be used to detect the intracellular tissue-specific protein fragments. In case of THA, such tissue-specific protein fragments have to be determined, e.g. derived from soft tissues and/or from skeletal muscle. 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. Besides a relative and quantitative assessment, another 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. Damage to tendons and musculature will be visualized by means of MRI. The amount of fatty atrophy of the muscles and (partial) tendon tears or detachments will be used to measure the actual damage following THA, Additionally, surgical time and length of hospital stay will be recorded as secondary clinical outcome measures.	—

Measure

Time frame

Tissue damage will additionally 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. A second set of antibodies will be used to detect the intracellular tissue-specific protein fragments. In case of THA, such tissue-specific protein fragments have to be determined, e.g. derived from soft tissues and/or from skeletal muscle. 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. Besides a relative and quantitative assessment, another 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. Damage to tendons and musculature will be visualized by means of MRI. The amount of fatty atrophy of the muscles and (partial) tendon tears or detachments will be used to measure the actual damage following THA, Additionally, surgical time and length of hospital stay will be recorded as secondary clinical outcome measures.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)